The Effectiveness of Telehealth Gait Retraining in Addition to Standard Physical Therapy Treatment for Overuse Knee Injuries in Soldiers: A Protocol for a Randomized Clinical Trial

doi:10.21203/rs.3.rs-2492896/v1

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Research Article

The Effectiveness of Telehealth Gait Retraining in Addition to Standard Physical Therapy Treatment for Overuse Knee Injuries in Soldiers: A Protocol for a Randomized Clinical Trial

https://doi.org/10.21203/rs.3.rs-2492896/v1

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published 16 Oct, 2023

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Introduction:

Running is the most common cardiovascular exercise in the military. However, there is a high incidence of running-related overuse injuries that reduces military readiness. Gait retraining is a common intervention to treat running-related injuries, but the high cost of equipment and lack of clinician expertise and availability reduces utilization. Gait retraining intervention in a telehealth format might improve feasibility. The purpose of this randomized clinical trial is to determine the effectiveness of a telehealth gait retraining intervention on pain, self-reported function, and biomechanical risk factors for injury in Service Members who present to a Military Health System physical therapy clinic with an overuse knee injury.

Methods

This is a parallel, two-arm, single-blind randomized clinical trial. The two independent variables are intervention (2 levels: telehealth gait retraining intervention with standard of care or only standard of care) and time (3 levels: baseline, 10-weeks or post-intervention, 14-weeks). The primary dependent variables are: 1. worst reported pain during and after running as measured on a visual analog scale; and 2. foot strike pattern during running. Secondary outcomes include worst non-knee pain during running, worst overall knee pain, self-reported function (University of Wisconsin Running Injury and Recovery Index, Single Assessment Numerical Evaluation, Anterior Knee Pain Scale), and running biomechanics (step rate, step length, ground contact time, peak knee adduction angle, peak hip adduction angle, average vertical loading rate, instantaneous vertical loading rate, knee stiffness, and peak rearfoot inversion moment).

Discussion

The effectiveness of a telehealth gait retraining intervention to reduce pain and modify foot strike pattern is not known. The results of this study may help determine the effectiveness and feasibility of a telehealth gait retraining intervention to reduce pain, change foot strike, improve function, and improve running gait biomechanics.

Trial registration:

ClinicalTrials.gov, NCT04269473. Registered 05 February 2020, http://clinicaltrials.gov/NCT04269473.

Running injury

running biomechanics

rehabilitation

Soldiers need to possess excellent muscular strength and cardiovascular endurance to perform military duties well. Running is the most common mode of exercise for Soldiers to maintain cardiovascular fitness. However, running-related overuse injuries reduce military readiness, result in lost duty time, and cost money. Running was attributed to approximately 30% of all injuries sustained by Soldiers(1, 2) and approximately 50% of all sports, exercise or recreational activity-related injuries sustained by Soldiers.(3) The rate of overuse injuries associated with running in Soldiers is similar to that of civilian populations, where 19–79% of recreational runners incur an overuse injury each year.(4)

In both military and civilian runners, the knee is the site of most running injuries.(3–6) The presence of knee pain reduces military readiness as Soldiers are either unable to complete or have limited capacity to complete basic military tasks that load the knee.(7, 8) Unfortunately, chronic symptoms are common after running injuries. At long-term follow-up, approximately half of atraumatic knee pain patients report persistent pain and reduced function.(9–11) Recurrence is also common after running injuries affecting the knee(12) and a prior history of injury is a recognized risk factor for running injuries in both civilian and military populations.(13–15) Optimal treatment strategies for overuse knee injuries in are needed to avoid subsequent injury, restore running ability, and return to duty as quickly as possible.

Optimal treatment of musculoskeletal injuries due to running may reduce the risk of recurrence and improve return to duty rates. Treatment for knee pain during running has typically involved strengthening and stretching, but these interventions do not adequately address running biomechanics,(16) a common underlying cause of running-related knee injuries. (Davis) Gait retraining interventions have been effective at inducing specific changes to running biomechanics with long-term effects.(17, 18) A comprehensive approach to running-related injury treatment combining a gait retraining intervention with a standard of care strengthening and stretching intervention may improve injury recurrence and return to duty rates in Soldiers.(19)

Gait retraining interventions are complex treatments based on motor control principles to alter an individual’s running biomechanics. Substantial enhancements to injury prevention and rehabilitation outcomes in athletes were reported by multiple research studies using gait retraining.(17, 20, 21) In military populations, improvements in pain, function and occupational readiness, as well as reductions in healthcare cost and injury rates following gait retraining were reported.(19, 22, 23) Large group running gait retraining during Basic Military Training resulted in significantly fewer trainees both removed from training and separated from service because of injury.(19) Specifically, gait retraining to change foot strike pattern from a rearfoot strike (RFS) to a non-rearfoot strike (NRFS) has been shown to improve function, pain and known biomechanical factors related to running knee injury to include patellofemoral joint stress and components of the vertical ground reaction force.(24–26) However, most gait retraining interventions require multiple clinic visits(27) which limits feasibility in physical therapy clinics in the Military Health System.

With increasing technological capabilities, clinicians and researchers have sought new ways to leverage consumer technology for telehealth interventions. Administering a gait retraining intervention in a telehealth format might improve feasibility through decrease cost and time demands of treatment compared to the traditional in-clinic format. Recently, a biomechanical risk factor for overuse injury, high instantaneous vertical loading rates, were successfully decreased in healthy runners using a telehealth gait retraining intervention to increase step rate.(28) However, increasing habitual running step rate may only be suitable for runners with greater loading rates, as no change in loading rates was noted with increasing step rate in runners with increasing step rate in runners with low loading rates.(29) Other than step rate, adaptation of a non-rearfoot strike pattern in runners with a rearfoot strike pattern may be an effective and feasible treatment for overuse knee injuries. Gait retraining interventions focused on foot strike pattern may be more suitable for patients with an overuse knee injury than those focused on step rate. Greater decreases in loading rate and knee joint work per kilometer occurred after healthy runners converted from a habitual rearfoot strike pattern to a non-rearfoot strike pattern compared to increasing step rate.(29) Additionally, greater decreases to vertical loading rates over a longer time period was reported in healthy runners who completed a foot strike pattern intervention compared to those who completed a step rate intervention.(30) However, the effectiveness of a telehealth gait retraining intervention to adopt a non-rearfoot strike pattern during running on biomechanical and clinical outcomes in patients with overuse knee injuries is unknown.

The purpose of this randomized clinical trial is to determine the effectiveness of a telehealth gait retraining intervention on pain, foot-strike, self-reported function, and biomechanical risk factors for injury in Soldiers who present to a Military Health System physical therapy clinic with an overuse knee injury. The primary objectives are to assess the effect of telehealth gait retraining on pain during/after running and observed foot strike pattern during running. We hypothesize that patients who receive the telehealth gait retraining intervention in addition to standard of care will report greater improvements in self-reported pain intensity and will demonstrate a greater proportion of patients who display an NRFS running gait pattern than those who receive standard of care alone. Additional objectives are to assess the effect of telehealth gait retraining on self-reported function and gait biomechanics. We hypothesize that patients who receive the telehealth gait retraining intervention will transition from a rearfoot to a non-rearfoot strike pattern, will report greater improvements in function, and will demonstrate improved gait biomechanics (reduced foot strike index, foot angle, step rate, stride length, ground contact time, peak hip adduction angle, peak knee adduction angle, knee stiffness, peak rearfoot inversion moment, and vertical loading rates) during running.

Trial Design

This study will be a parallel, two-arm, single-blind randomized clinical trial. Participants will complete three data collection sessions before, immediately after, and one month after the intervention. Participants will receive either the telehealth gait retraining intervention with standard of care or only standard of care over eight weeks. During the eight-week intervention, all participants will follow-up at the discretion of their physical therapist (typically every 2–3 weeks), perform a rehabilitation program that home exercise program with or without supervised clinic sessions, and complete a standard return-to-run program that systematically progresses the duration, frequency, and intensity of running. Participants receiving the telehealth gait retraining intervention will also receive feedback on their running form via a smart device application. The flow of participants throughout this study is shown in Fig. 1.

The 2013 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) was followed in designing this clinical trial (Supplemental Materials).(31) The Consolidated Standards of Reporting Trials (CONSORT) statement and Template for Intervention Description and Replication (TIDieR) checklist will be followed in reporting the results of this clinical trial.(32, 33)

Participants and Study Setting

This randomized clinical trial will be a dual-site study. A total of 180 participants will be recruited for this study. Participants will be recruited from the cadet and active-duty Soldier population at Keller Army Community Hospital, United States Military Academy, West Point, NY or Womack Army Medical Center, Fort Bragg, NC who seek treatment for atraumatic knee pain.

To participate in this study, Service Members must be Department of Defense beneficiaries between the ages of 18 to 60 years, and report knee pain during and/or after running to be anywhere from a 3 to a 7 on the numerical pain rating scale. Potential participants who have a concurrent lower extremity injury, a running-limiting profile for something other than knee pain, rheumatoid or neurological disease, are pregnant or are deploying or moving within four months of consent will be excluded from the study. Potential participants who meet the preliminary inclusion and exclusion criteria and give their signed informed consent will be assessed additional screening criteria: evidence of internal derangement (i.e. ligamentous instability or meniscal pathology), adequate lower extremity strength, and a habitual rearfoot strike during running. Additionally, potential participants will be screened for lower extremity strength deficits and a non-rearfoot strike pattern during running. Lower extremity strength will be assessed by the participant’s ability to perform 10 consecutive single leg squats, bilaterally and 20 consecutive single-leg heel raises, bilaterally. Inability to perform single leg squats or heel raises will prevent study participation. Foot strike pattern will be assessed during a treadmill run at a self-selected speed that the participant would run at for an easy 20-minute run (Ford 2013). After participants run for 3 minutes, a ten second video of their feet in the sagittal plane will be recorded at 240 Hz on mobile device (Apple Inc., Cupertino, CA, USA) inside the OnForm: Video Analysis application (OnForm, Inc., Fort Collins, CO, USA). An investigator blinded to the treatment group will determine foot strike pattern by reviewing recorded footage of 10 seconds of consecutive steps of the left and right feet.(34) A rearfoot strike pattern will be defined contacting the ground with the posterior third of the shoe during the majority of steps over 10 seconds.(34)

Randomization and Blinding

Only participants who meet the screening criteria will be enrolled in the study. The baseline data collection will include a running-related injury history questionnaire and report their worst pain experienced during and after running in the past 7 days on visual analogue scales (VAS). Additionally, participants will report their perceived knee function, condition, and running ability by completing the Anterior Knee Pain Scale (AKPS) (35), Single Assessment Numerical Evaluation (SANE) (36, 37), and the University of Wisconsin Running Injury and Recovery Index (UWRI) (38, 39), respectively. After completing all surveys, participants’ three-dimensional running biomechanics will be measured using a force instrumented treadmill and motion capture system.

Following the baseline data collection, participants will be randomly assigned to either the control group or the experimental group using a concealed allocation process. The participant’s group assignment will be recorded with a unique participant identifier until completion of all data collection or through the final follow-up. Creation of the randomization sequence and concealment of participant group assignments will be completed by an individual not involved with the current study. The randomization sequence will utilize a random permuted block approach with a 1:1 allocation ratio to keep control and experimental group size similar throughout the data collection process.(40) The investigator determining foot strike pattern will be blinded to group allocation. The patient, physical therapist, and investigators collecting biomechanics data will be aware of the participant’s treatment group.

Interventions

Standard physical therapy (active control group and study intervention group)

During treatment, participants in both the control and experimental groups will receive standard of care physical therapy treatment that consists of a home exercise program with or without additional supervised clinic visits.(41) Participants will follow-up at the discretion of their referring physical therapist, or approximately every 2–3 weeks. Potential elements of the standard physical therapy treatment for overuse knee injuries are shown in Fig. 2.(41)

A supplemental exercise program for both the control group and intervention group will also be employed to target muscles that are utilized more extensively when running with a non-rearfoot strike. The exercises consist of lower extremity strength and flexibility exercises for the knee flexors, ankle plantarflexors, and plantar intrinsic foot musculature (Appendix B).

Standard Return to Run Program (active control group)

The return-to-run program is a standard prescription of running volume progression (Table 1) designed to allow the patient to adapt to gradually increasing load. Participants in the control group will not receive any verbal or tactile cues, coaching, or instruction to change their running form.

Table 1. Standard Return-to-Run Program

Phase	Rate of Perceived Exertion	Walk Interval	Run Interval	Total Distance
1	3/10 (“Easy”)	2 Minutes	3 Minutes	1.0 Mile
2	3/10 (“Easy”)	2 Minutes	3 Minutes	1.5 Miles
3	4/10 (“Somewhat Easy”)	2 Minutes	4 Minutes	1.5 Miles
4	4/10 (“Somewhat Easy”)	2 Minutes	4 Minutes	2.0 Miles
5	5/10 (“Somewhat Hard”)	1 Minute	4 Minutes	2.0 Miles
6	5/10 (“Somewhat Hard”)	0 Minutes	All Minutes	2.0 Miles
Stretch and warm-up for 10 to 15 minutes before exercise. Have at least *one day of rest* in between each run. Try each phase at least TWICE before progressing to the next phase. IF you experience swelling, stiffness, or an increase in pain during and/or after running, DO NOT progress to the next phase. Stay in the phase until you can complete it without swelling, stiffness, or an increase in pain. Perform at the defined rate of perceived exertion AND on level surfaces – NO HILLS. Use good jogging shoes that are no more than 6 months old.

Return to Run Program with Telehealth Gait Retraining (study intervention group)

Participants in the intervention group will receive telehealth gait retraining instruction on how to transition from a rearfoot strike pattern to a non-rearfoot strike pattern during their progression through the standard return-to-run program. Feedback will be facilitated in OnForm software application accessible via the participants’ personal mobile device. Participants in the intervention group will be asked to record a ten second video of themselves running on a treadmill from the sagittal plane view. To standardize the view of each video, the participants will be instructed to ensure that the video: aligns the bottom of the screen with the treadmill base and holds the mobile device as straight up and down as possible, captures the feet hitting the treadmill belt, and only records video from the waist down. The video will be shared to a therapist who then provides auditory and visual feedback to the video before sending back to the participant.

Therapists will use standardized visual and verbal cues reported by previous interventions which were successful in changing foot strike pattern and increasing step rate in previous studies for their feedback (Appendix A).(24, 42–44) Each therapist providing feedback to participants will undergo training to ensure uniformity in use of auditory and visual feedback to decrease the potential effect of therapist on intervention outcome. Participants view the provided feedback in their OnForm account at least twice and once before their next run. Running videos will be recorded and therapist directed feedback will be shared once a week during the first four weeks, then again at weeks six and eight of the eight-week intervention. The faded feedback schedule aligns with motor learning theory for new motor skill acquisition and retention (45) and previous gait retraining interventions reported long-term retention with similar faded feedback schedules.(18, 22)

Data Collection

At the baseline data collection, participants will change into athletic shorts, short-sleeve shirt, and their normal running shoes. Their height will be measured before preparing for three-dimensional gait analysis. Three-dimensional positions of retroreflective markers will be recorded using a nine-camera motion capture system (Vicon, Oxford, UK) at 120 Hz. Ground reaction forces will be recorded simultaneously and in synchronization with the motion capture system at 1200 Hz via force plates arranged in-series on an instrumented treadmill (AMTI, Watertown, MA, USA).

Retroreflective markers will be positioned on participants’ trunk, pelvis, and lower extremity. Specifically, markers will be positioned on participants bilateral acromion processes, iliac crests, greater trochanters, medial and lateral femoral epicondyles and malleoli, and first and fifth metatarsal heads to define segmental coordinate systems. Additionally, local coordinate systems for tracking segments will be defined by markers positioned on bilateral anterior and posterior superior iliac spines to track the pelvis segment, and bilateral superior, lateral, and medial shoe heels to track the foot. The trunk’s local coordinate system will be defined by four noncolinear markers on a thermoplastic shell positioned over the thoracic spine via a neoprene vest. Local coordinate systems for the thigh and shank will be defined by four noncolinear markers on thermoplastic shells positioned directly over the distal thighs and proximal shanks and secured using self-adherent wraps. A standing calibration trial will be recorded, after which all markers defining segmental coordinate systems will be removed.

Treadmill speed will be set at a self-selected speed that the participant would run at for an easy 20-minute run.(46) After participants run for 6 minutes, a twenty-second motion capture trial will be recorded. Treadmill speed will then be set to a standard speed of 2.68 m/s and another twenty-second motion capture trial will be recorded. After the last week of the intervention period (week 8), all participants will be asked to return to the clinic for the post-intervention data collection. At the post-intervention and follow-up visits, self-reported outcomes will be completed and running biomechanical analysis will be collected from all participants as previously. An additional treadmill speed condition, the speed that was self-selected during the pre-intervention visit, will be collected during the post-intervention and final follow-up data collection visits.

A visual Stroop task will be applied during the follow-up visit to assess retention of the newly learned running gait. The application of the dual-task paradigm requires participants to devote attentional resources to the cognitive task, which limits their ability to actively control their running gait, revealing the degree of motor learning. The visual Stroop task will be projected on a monitor positioned at eye level directly in front of the participant. The words red, blue, green, brown, and purple will be displayed in either with the font color matching the meaning of the word (congruent) or not matching (incongruent).(47) Color-word stimuli will be presented every three seconds during the recorded running trial and participants will be instructed to report the font color and not the word meaning. Response time will be automatically recorded via Bluetooth ear pods using SuperLab 6 stimulus presentation software (Cedrus, San Pedro, CA). Running biomechanics will be concurrently recorded while the participant runs at their preferred pace on the treadmill. After the follow-up data collection, subjects will be considered complete with the study.

Outcome Measures

Patient Self-Reported Outcome Measures

Each participant will complete an assessment of pain using a NPRS and assessments of function with the AKPS, the SANE and the UWRI. The NPRS measures a patient’s subjective report of pain, with ratings ranging from 0 (no pain) to 10 (worst possible pain). Participants will rate knee pain during running, after running, and their worst pain over the past 7 days. Participants will also rate their worst pain in a region other than their knee during running over the past 7 days. A composite score will be calculated as the sum of each rating. A composite NPRS is a valid and reliable measure of pain with a minimum important difference of 1.5 for a small change, 3.0 for a medium change, and 3.5 for a large change.(48, 49) The AKPS consists of 13 questions about a variety of running related tasks and knee function, such as limping, walking, running, jumping, stairs, knee swelling, and pain. Scores range from 0-100, with lower scores indicating greater disability. The AKPS is a reliable and responsive measure of function in patients with anterior knee pain, with a minimal detectable change of 14 points.(35) The SANE is a global rating scale that is a valid and responsive tool for measuring knee function. The SANE is scored on a 0-100% scale with 0% equating to unable to function and 100% equaling full function.(36, 37, 50) The MCID of the SANE for lower extremity conditions has been reported as 7% at 6-month follow-up. The UWRI is a running-specific patient reported outcome measure and is scored on a scale from 0–36 with 36 equaling full running function and a score of 0 equating to inability to run. The UWRI is reliable, valid, and responsive to change after a running-related injury, with measurement properties superior to other patient reported outcome measures typically used in this population. The MCID for the UWRI is 8 points.(38, 39)

Foot Strike Pattern

Two-dimensional (2D) sagittal plane running video will be collected while the participant runs on an instrumented treadmill (AMTI, Watertown, MA, USA) using an Apple iPad Pro (Apple, Cupertino, CA) sampling at 240 hertz (Hz) to assess foot strike pattern (FSP). The FSP utilized for the majority of 10-seconds of the third running trial will used to categorize participants’ FSPs dichotomously into 1 of 2 groups. A rearfoot strike (RFS) will be considered initial plantar contact observed in the posterior one-third of the foot. A non-rearfoot strike (NRFS) will be considered initial plantar contact observed in the anterior two-thirds of the foot. If both anterior and posterior aspects of the foot make initial contact with the ground simultaneously, the foot strike will be considered an NRFS pattern. This method has previously demonstrated excellent inter- and intra-rater reliability and validity when compared with plantar pressure insoles.(34, 51)

3D Gait Analysis

Marker trajectories will be filtered using a low-pass second-order Butterworth filter with a cutoff frequency of 12 Hz. Kinetic and kinematic analyses were performed based on the Plug-In Gait model (Vicon Nexus 1.8.2, Oxford Metrics, UK). Variables of interest were calculated using Visual 3D (C-Motion Bethesda MD) and extracted using custom processing software (Matlab, MathWorks, Natick MA). Temporal spatial variables of interest, kinematic, and kinetic data will be collected during gait using a 16-camera, three-dimensional motion capture system as each participant runs on a force-plate instrumented treadmill, respectively. Variables of interest are step rate, ground contact time and will be calculated from the force plate signal. Foot contact and toe off events will be defined as when the vertical ground reaction force exceeds and falls below a 50N threshold, respectively. Step rate is the number of foot contacts per minute, contact time is the time between foot contact and toe off events, and step length is the distance between the proximal contralateral and ipsilateral foot segments at their respective foot contact events plus the distance traveled by the treadmill belt. Kinematic variables of interest are peak knee adduction angle and peak hip adduction angle. Hip and knee angles were calculated using rigid body principles and the joint coordinate system with an XYZ order of rotation (Cole, Grood & Suntay). Peak hip adduction angle was the maximum frontal plane hip angle during the first 60% of the stance phase. Peak knee adduction angle was the maximum frontal plane knee angle during the first 60% of the stance phase. Kinetic variables of interest include average vertical loading rate, instantaneous vertical loading rate, knee stiffness, and peak rearfoot inversion moment. Average vertical loading rate was defined in two ways: 1. the average slope from 20–80% of the vGRF magnitude at the impact peak; and 2. the average slope from 3–12% of stance time.(52) Data from the entire 20-second trial on the left and the right of the running trial will be analyzed. Three-dimensional motion capture data will be processed with all kinematic variables being extracted using Visual 3D (C-Motion, Germantown, MD, USA) whereas kinetic variables derived from vertical ground-reaction force of interest will be processed and extracted using custom code written in Matlab (MathWorks, Natick, MA, USA).

Data Analysis

Based on an a priori power analysis of conservative estimates of effect size based on previously published data(24) with an effect size of 0.25, \(\alpha\) set at 0.05, and \(\beta\) set at 0.80, it was determined that at least 64 participants per group (control and intervention) were required to adequately power this investigation. To account for attrition, screening failures, and possible re-injury, we will enroll a total of 180 runners to sufficiently power the protocol in order to adequately detect evident effects of the intervention

This study's goal is to measure the effectiveness of gait retraining in terms of longitudinal change in outcomes over 12 weeks. Descriptive statistics, including measures of central tendency and dispersion, will be calculated for demographic data. Frequency distributions will be estimated for categorical data. Separate 2-by-3 mixed-model analyses of variance (ANOVA) with group as the between-subjects factor (telehealth gait retraining plus standard physical therapy and standard physical therapy alone) and time as the repeated measure within-subjects factor (baseline, 8 weeks, and 12 weeks) to determine the effect of telehealth gait retraining on pain, self-reported function, and running biomechanics. Alpha will be set at 0.05 for all omnibus comparisons, which are the group*time interaction, the main effect for group (fixed factor), and the main effect for time (repeated measure). Planned pairwise comparisons will be performed to examine significant main effects for group using independent t-test, and time using paired t-tests. Alpha for planned pairwise comparisons will be corrected using the Sidak’s correction to control for family-wise type I error. The Cohen d coefficient will be used to assess effect size between pairwise comparisons. Prior to performance of the ANOVAs, all outcome measures will be assessed for normality. The appropriate non-parametric statistical tests will be used for any non-normality distributed outcomes. All statistical analyses will be conducted using IBM SPSS v.27 (IBM Corp, Armonk, NY).

When post-intervention data points are missing, data will be replaced using multiple imputation for participants who received their allocated intervention (53). Participants who only attended a baseline session, but did not complete other data collection sessions will be considered to have not completed the allocated intervention and will be excluded. All statistical analyses will be performed with the statistical package SPSS version 28 (IBM, Chicago, IL, USA).

The purpose of this study is to determine the effectiveness of a telehealth gait retraining intervention on self-reported pain during and after running, self-reported function, and biomechanical risk factors for injury in military Service Members who present to a Military Health System physical therapy clinic with an overuse knee injury. While gait retraining to change foot strike pattern from a RFS to a NRFS has been shown to improve function, pain and known biomechanical factors related to running knee injury (22, 24–26), most gait retraining interventions require multiple clinic visits (27) which limits feasibility in military physical therapy clinics. A telehealth gait retraining intervention might improve feasibility through decreased cost and time, but the effectiveness of a telehealth gait retraining intervention in patients with overuse knee injuries is not known. The results of this study may help determine the effectiveness and feasibility of a telehealth gait retraining intervention. Specifically, this study will determine if pain intensity differs when a standard physical therapy rehabilitation program is combined with either a return-to-run progression with telehealth gait retraining or a return-to-run progression without gait retraining after completion of the intervention and at four weeks post-intervention to assess retention of any potential benefits. Additionally, this study will determine if self-reported function and biomechanical risk factors for injury are different for the two groups after completion of the intervention and at four weeks post-intervention.

This study has several limitations and design constraints. The primary limitation is that the physical therapists and administering the gait retraining intervention and the patients will not be blinded to the treatment groups. However, but outcome assessors will be blinded to group allocation to minimize potential bias. Outside of the telehealth gait retraining intervention, physical therapists prescribed individualized rehabilitation programs for each participant, creating potential inequities in the quantity and/or quality of interventions. This aspect of the trial was kept as pragmatic as possible to maximize generalizability. While the study was designed to be most generalizable to a military setting, study findings may also be transferable to patients with overuse knee pain in civilian populations.

This study was approved by the Naval Medical Center Portsmouth; protocol ID number RHC-A-19-035/19KACH0004, initially approved October 2019. Modifications were approved February 2020, July 2020, September 2020, January 2021, August 2021, February 2022, July 2022, and December 2022. Recruitment began August 2020 and will be tentatively completed in May 2023.

Ethics Approval and Consent to Participate

This protocol was approved by the Naval Medical Command – Portsmouth and High Point University Institutional Review Boards. A continuing review is conducted annually; last completed in August 2022.

Author Contributions

Table 1. Author roles and responsibilities. PI, Principal Investigator; AI, Assistant Investigator.

Study Personnel	Role	Responsibilities
MSC	PI	Project management; protocol development; data analysis; manuscript preparation
EMM	AI	Project management; participant recruitment/consent; protocol development; blinded outcomes assessor; data analysis; manuscript preparation
RAB	AI	Participant recruitment/consent; protocol development; blinded outcomes assessor; data analysis; manuscript preparation
NR	AI	Protocol development; blinded outcomes assessor; data analysis; manuscript preparation
KRF	AI	Protocol development; data analysis; manuscript preparation.
DLG	AI	Project Management, protocol development; data analysis; manuscript preparation.

Author contributions are consistent with the Contributor Roles Taxonomy (CRediT) (docs.casrai.org/CRediT) methodology for attributing contributions.

Competing Interests

The authors completed the International Committee of medical Journal Editors (ICJME) Form for Disclosure of Potential Conflicts of Interest. They reported no conflicts of interest.

Acknowledgements

This work was supported in part by the Uniformed Services University, Department of Physical Medicine & Rehabilitation, Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) (HU00011920011). The authors would like to specifically thank the following people for their contributions to this project: Ms. Linzie Wagner, Ms. Whitley Lucio, Ms. Brittney Robinson, and Dr. Amy Weart for their hard work and expertise in the management and regulatory guidance of the project; MAJ Will Pitt and MAJ John Mason for their contributions to development of the protocol.

Funding

This work was supported by a grant from the Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) program at the Uniformed Services University of the Health Sciences (USUHS). USUHS/MIRROR did/will not have a role in the study design; collection, analysis, interpretation of data, and writing of the report. USUHS/MIRROR provided technical assistance with regulatory approval and data management systems. USUHS/MIRROR will have to approve the content of the final report submission.

Availability of Data and Materials

The coded electronic research data for this study will be stored in Research Electronic Data Capture (REDCap), an encrypted, access-controlled, password-protected electronic data capture and management system housed on a DoD server and maintained by the Uniformed Services University of the Health Sciences Information Technology. Data from the study are available by email request to the lead author for the purpose of systematic review and meta-analysis.

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published 16 Oct, 2023

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Editorial decision: Major revision
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The Effectiveness of Telehealth Gait Retraining in Addition to Standard Physical Therapy Treatment for Overuse Knee Injuries in Soldiers: A Protocol for a Randomized Clinical Trial

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Journal Publication

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Abstract

Introduction:

Methods

Discussion

Trial registration:

Figures

Background

Methods

Trial Design

Participants and Study Setting

Randomization and Blinding

Interventions

Standard physical therapy (active control group and study intervention group)

Standard Return to Run Program (active control group)

Return to Run Program with Telehealth Gait Retraining (study intervention group)

Data Collection

Outcome Measures

Patient Self-Reported Outcome Measures

Foot Strike Pattern

3D Gait Analysis

Data Analysis

Discussion

Trial Status

Declarations

References

Supplementary Files

Status:

Journal Publication

Version 1