An assessor-blinded, parallel-controlled RCT will be implemented to observe the efficacy
and safety of Baduanjin in patients with FAI, which will be carried out in Dongzhimen
Hospital, the First Affiliated Hospital of Beijing University of Chinese Medicine.
A total of 72 patients with FAI who are eligible according to the inclusion and exclusion
criteria will be recruited and randomly assigned (in a 1:1 ratio) to Baduanjin or
control group. Outcomes will be evaluated at three timepoints: at baseline, 2 weeks,
and 4 weeks.(Fig. 1) (Spirit Checklist 8,9)
Fig. 1 Flow Chart of the Study
The trial has been approved by the Research Ethical Committee of Dongzhimen Hospital, the First Affiliated Hospital of Beijing University of Chinese
Medicine (no. DZMEC-KY-2019-18) and it will follow the principles of the Consolidated Standards of Reporting Trials
(CONSORT) statements as well as the Declaration of Helsinki. The trial is registered
with the Chinese Clinical Trial Registry (ChiCTR1900021939). Any changes of the protocol
will be reported to the Research Ethical Committee. They will determine whether the
change of the protocol is necessary. The members of the study team will supervise
the safety of participants during the trial. (Spirit Checklist 5d,24,25)
Participants and recruitment
The participant recruitment has been conducted in the outpatient clinics of the Rehabilitation
Department and Orthopedics Department of Dongzhimen Hospital, the First Affiliated
Hospital of Beijing University of Chinese Medicine. An advertisement has also been
posted on the hospital’s bulletin board. The adverts provided the contact information
of the eligibility screener (who doesn’t involve in other study tasks). (Spirit Checklist
The inclusion criteria are as follows, it was proposed by the International Ankle
Consortium in 2014(27):
A history of at least 1 significant ankle sprain.
The initial sprain must have occurred at least 12 months prior to study enrollment.
Was associated with inflammatory symptoms (pain, swelling, etc.).
Led to at least 1 interrupted day of desired physical activity.
The most recent injury must have occurred more than 3 months prior to study enrollment.
We define an ankle sprain as “An acute traumatic injury to the lateral ligament complex
of the ankle joint as a result of excessive inversion of the rear foot or a combined
plantar flexion and adduction of the foot. This usually results in some initial deficits
of function and disability (28).”
A history of the previously injured ankle joint “giving-way” (with at least two episodes
of “giving-way” in the 6 months prior to study enrollment) and/or “recurrent sprain”
and/or “feelings of instability.”
We define “giving-way” as “The regular occurrence of uncontrolled and unpredictable
episodes of excessive inversion of the rear foot (usually experienced during initial
contact while walking or running), which do not result in an acute lateral ankle sprain.”(27)
We define “recurrent sprain” as two or more sprains to the same ankle (28).
We define “feeling of ankle joint instability” as “The situation whereby during activities
of daily living (ADL) and sporting activities, the participant feels that the ankle
joint is unstable, and is usually associated with the fear of sustaining an acute
ligament sprain (28).”
Cumberland Ankle Instability Tool (CAIT) (29) score < 24.
Written informed consent.
The exclusion criteria are as follows, it was proposed by the International Ankle
Consortium in 2014(27):
A history of previous surgeries to the musculoskeletal structures (i.e., bones, joint
structures, and nerves) in either lower limb extremity.
It is understood and accepted in clinical and research practice that surgery to repair
insufficient joint structures is designed to restore structural integrity but creates
residual changes in the central and peripheral portions of the nervous system. Even
with appropriate rehabilitation and follow-up management, there are concomitant neuromuscular
and structural alterations after surgery that would confound the ability to isolate
the effects of CAI.
A history of a fracture in either lower limb extremity requiring realignment.
Similar to the first exclusion criterion, significant compromise to skeletal tissue
threatens the internal validity of the selection of participants with isolated CAI.
Acute injury (i.e., sprains or fractures) to musculoskeletal structures of other lower
extremity joints in the previous 3 months, which affected joint integrity and function
resulting in at least 1 interrupted day of desired physical activity.
Central nervous system disease, ear disease history, cognitive dysfunction, or other
diseases which make the participants unable to cooperate with the rehabilitation treatment
and assessment. (Spirit Checklist 10)
The patients will be notified about the study method and processes, and they will
be informed of their rights, the benefits of taking part in the trial, and the things
they will do if they consent to take part. The participants are voluntary to participate in the trial and they will be able to withdraw from the trial at any point for any reason. If
there are any adverse events (including any accidents), the participants will be asked
if they want to withdraw. When the participants withdrew from the trial, their data
will be saved to analyze in the end of trial. The participants will sign the informed
consent when they agree to participate in the trial.
The trial will entail a preliminary pilot study (based on the availability of resources);
therefore, the sample size will be small. After several rounds of discussion and demonstration,
the experts of the study group decided to include patients with the minimal clinical
effective sample size of 30 patients in each group. Considering a 20% loss rate, 36
patients should be included in each group. The random envelope method was used for grouping concealment. (Spirit Checklist 14)
Randomization and allocation concealment
A random number list has been generated through the computer by the study statistician.
The random envelope method was used for grouping concealment. Patients who are eligible
according to the inclusion and exclusion criteria and consent to take part in the
trial will be assigned to the Baduanjin or control groups. The group allocation outcome will be sealed in opaque envelopes. The group allocation manager will open the envelope
and inform the eligible participants their group assignment. (Spirit Checklist 16a,16b,16c)
The eligibility screener, outcome assessor, data analysts and data collectors will
be blinded to each participant’s group allocation. The eligibility screener will be responsible to collect the baseline data. The group allocation manager will inform the Chinese medicine rehabilitation specialist about the participants’
information in the Baduanjin group. However, during the trial, it would be impossible
to blind participants regarding group allocation. Before the trial, we will explain
the differences between the two study groups to the participants. We will make clear
to the participants that they must do the exercise in accordance with the trial plan
if they consent to participate. The eligibility screener, group allocation manager,
and outcome assessors will not be responsible for patient treatment or data analysis.
The rehabilitation specialists and Chinese medicine rehabilitation specialist will not be responsible for data analysis
or any other study work. Before the data analysis, all the data will be saved by the
researcher who is responsible to the data analysis, the unblinding will last until
the data analysis ends. All the researchers have been trained about the trial plan
and schedule. They will not violate the trial schedule to communicate the contents
regarding as group allocation and data analysis privately. (Spirit Checklist 17a,17b)
Participants allocated to the control group will receive conventional physical therapy(30-32) including muscle strengthening, balance function training, gait training, etc. The rehabilitation specialists will arrange suitable therapy for the participants.
All patients will undergo 30 min of conventional physical therapy every day, once
a day, 5 days per week (followed by 2 days of rest) over 4 weeks, leading to a total
of 20 sessions. (Spirit Checklist 11a)
Participants allocated to the Baduanjin group will be trained Baduanjin exercise by
a Chinese medicine rehabilitation specialist in addition to the control therapy. The Chinese medicine rehabilitation specialist is qualified and experienced in teaching
Baduanjin. The Baduanjin group will be subjected to additional Baduanjin exercise
after conventional physical therapy, the Baduanjin training would be consistently
performed for 30 min every time. The Baduanjin group participants will grasp the Baduanjin
exercise before the trial. The Chinese medicine rehabilitation specialist will teach
participants the Baduanjin and protect them. (Spirit Checklist 11a)
In this study, we selected several objective evaluation parameters to observe and
investigate the outcome. Outcome measures will include the surface electromyography
(sEMG) results of the bilateral erector spinae, tibialis anterior, and peroneus longus
muscles extracted from graphic information by FlexComp Infiniti System (Canada), balance
function outcome by NeuroCom Balance Manager system(46mm*46mm,Basic Balance Master, USA), and CAIT score. All primary and secondary outcome measures will be assessed at baseline,
2 weeks, and 4 weeks by experienced and qualified outcome assessor.
The outcome assessor who has been trained the schedule of trial assessment will be
blinded to each participant’s group allocation until the end of trial. (Spirit Checklist
Basic characteristic variables
The two groups participants’ demographic information including gender, age, ethnicity,
occupation, medical history and other detailed information will be recorded and collected
at baseline to compare their statuses and features. The rehabilitation specialists
will monitor the participants’ status and measure the participants’ vital signs, such
as the blood pressure, respiration rate, and pulse.
Primary outcome measures
1) sEMG results: The fibula muscle plays an important role in supporting the ankle
joint, so we regard its strength as one of the primary outcome measures. The sEMG
oscillations of the erector spinae, tibialis anterior, and peroneus longus muscles
will be compared among each pair of bilateral muscles at the three timepoints (at
baseline, 2 weeks, and 4 weeks). The sEMG oscillations in bilateral muscle function
before and after treatment will also be recorded and assessed, as will the change
over time, from week 2 to week 4. The differences in all these bilateral muscle function
results will be compared between the Baduanjin and control groups.
2)Balance function: The evaluation equipment of Neurocom Balance Manager system includes
a 46mm*46mm fixed force plate, a 46mm*46mm foam surface, two data processors, and a screen. The evaluation outcomes are showed in chart, the (center
of gravity) COG track presented in each evaluation condition, a comprehensive score that showed patients’
COG control ability also in the chart. The evaluation items include Modified Clinical
Test of Sensory Interaction on Balance(mCTSIB), Weight Bearing Squat (WBS), Limits
of Stability (LOS), Unilateral Stance (US), and Rhythmic Weight Shift (RWS). The characteristics
of balance function will change under different conditions. The differences in balance
function between the groups, and the trend in balance function over time in the two
groups, will be assessed.
Secondary outcome measures
The CAIT questionnaire(33) will be used as the secondary outcome measures. The questionnaire includes 9 self-reported
questions that the participants should answer. The contents involve to the pain around
of ankle joint, balance function, ankle sensorimotor function, the condition of ankle
sprains and the severity of ankle instability. The higher the questionnaire score,
the better the ankle function. (Spirit Checklist 12)
If there are any adverse events during the trial, the researcher will report it to
the Research Ethical Committee, and record it on the case report form(CRF). Furthermore, the researchers will protect the participants and arrange adaptive
exercise for the participants according to the study schedule. If the participants
have any adverse events (recurrent ankle sprain, fatigue, and other adverse events),
the researchers will take emergency treatment and the expert in the study group will
come to participate in the treatment. The participants can withdraw from the trial
if there is the need to suspend the exercise. (Spirit Checklist 11b,22,30)
This protocol has been planned according to relating items from the SPIRIT (Standard
Protocol Items: Recommendations for Interventional Trials) checklist (Additional file
1) and the SPIRIT figure (Fig. 2).
Fig. 2 Schedule of enrollment, interventions, and assessments(Spirit Checklist 13)
Data management and monitoring
When the assessor completes the CRF, the data collectors will save the contents of
CRF which include the baseline data and outcome measurements data in the computer.
The two data collectors will check the contents each other to make sure their data
is correct. All the materials and data including the electronic data and paper forms
will be saved in the database in the Clinical Research Center of Dongzhimen Hospital.
Only the members of the trial group have the right to check the data. The participants’
personal information will not be revealed. (Spirit Checklist 5d,18a,19,27,29)
The researchers blinded to group allocation will analyze the data using Statistical Product and Service Solutions (SPSS) software version 20.0. We will compare the data between the Baduanjin and control
groups. We will also assess the change in the results (including the sEMG bilateral
muscle data) of the Baduanjin and control groups over time at three timepoints (at
baseline, 2 weeks, and 4 weeks) to further explore the functional recovery over time
and the mechanism of action of Baduanjin in patients with FAI. For normally distributed
continuous variables, we will use the t-test, and for non-normally distributed continuous variables, we will use the Mann–Whitney U test. The continuous variables are showed with mean,
standard deviation and 95% confidential interval (CI). Count data will be described
using frequencies (with percentages), and compared using the chi-squared test. The intention-to-treat analysis will be conducted if there are participants who
suspended the test. P≤0.05 will define statistical significance. (Spirit Checklist