Questionnaire:
The questionnaire was developed jointly by all authors. In addition to the treatment and counseling experience of the pediatric orthopedic surgeons, the experience in creating and analyzing questionnaires of the involved psychiatrist was included. In the questionnaire, the practitioners' known fears of parents from the treatment experience as well as non-articulated, suspected concerns were included.
The following questionnaire structure was decided: First, we asked the parents about their own physical capacity and mental resilience in relation to the therapy of the child in a global statement. The participants were able to give a point value from 1 (not limited) to 6 (highly limited) (see table 1: statement).
Second, we were interested in the environment of the parents (Parents score). In detail, we asked about limitations in partnership, spare time, finances and professional life (see table 1: parents score). In the further questionnaire, the parents were able to tick a point value from 1 (not at all) to 6 (very strong)
Third, we wanted to determine the fears and worries of the parents concerning the future motion of the child (motion score). In detail, we asked about the feared limitation of movement and limitations in playing with other children (see table 1: motion score).
Finally, we wanted to inquire the parents' concerns about the child's global development. This meant in detail the question of the acceptance by other children, the restriction in choosing a career, having a hard time at school or being teased by other children (see table 1: child score). At the end, the parents had the possibility to add own concerns in a free text field.
To evaluate the questionnaire, the statements on physical capacity and mental resilience were analyzed individually. Furthermore, in the three scores (Parent Score, Motion Score and Child Score), the answers of one questionnaire were averaged for further analyze.
The questionnaire was given to the parents in written form and could always be carried out in a quiet corner of the treatment room.
Nr.
|
Statement
|
not limited
|
highly limited
|
|
1
|
Own current physical capacity (in relation to the therapy of the child)
|
1
|
2
|
3
|
4
|
5
|
6
|
|
2
|
Own current mental resilience (in relation to the therapy of the child)
|
1
|
2
|
3
|
4
|
5
|
6
|
|
|
|
|
Nr.
|
Parents Score
|
not at all
|
very strong
|
|
1
|
My partnership is burdened by the deformity.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
2
|
My spare time activities are limited by the deformity.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
3
|
My finances are limited by the deformity.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
4
|
My professional life is limited by the deformity.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
|
|
|
Nr.
|
Motion Score
|
not at all
|
very strong
|
|
1
|
The movement of my child will be limited.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
2
|
Playing with other children will be limited.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
|
|
|
Nr.
|
Child Score
|
not at all
|
very strong
|
|
1
|
My child will not be accepted by others.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
2
|
My child will be restricted in choosing a career.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
3
|
My child will have a hard time at school.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
4
|
My child will be teased.
|
1
|
2
|
3
|
4
|
5
|
6
|
|
Table 1: Clubfoot questionnaire emerged from our orthopedic and psychiatric experience. The questionnaire was translated into English language for publication.
Study Population:
20 study participants whose children / adoptive children were treated for clubfeet (see figure 1 a) in our outpatient clinic with the Ponseti method were included in the study. Treatment of the child with plaster casting in our outpatient clinic due to irredressible clubfoot and being available for the entire treatment period of the child were inclusion criteria for the parents. Further, we only included parents whose children started treatment at least 10 days after birth. All participants gave written informed consent. Parents with pre-existing mental illness requiring treatment or participating in other clinical trials to test pharmaceuticals, biological substances or medical devices were excluded from the study as well as parents, whose children had a redressable clubfoot position and did not need plaster casting.
Prior to the study, all parents were thoroughly informed about the expected course of treatment by reducing the deformity weekly with serial plaster casting, the requirement for percutaneous Achilles tenotomy in most cases and the preservation of the correction with braces. For ethical reasons, parents also had to be informed about the high success rate of the Ponseti method (up to 98%) before filling in the first questionnaire.
After the diagnosis of 'clubfoot' in the child, empirical data of the parents (study participants) was requested by questionnaire. We asked about relationship with the treated child (physical or adopted), specifics during pregnancy and birth, other illnesses of the child, other children with the same illness, pre-treatment information (internet, relatives / friends, books, others) and pre-existing mental illness.
Subsequently, we determined the Pirani score, interviewed the parents using our clubfoot questionnaire (see table 1) (T0) and started with the serial plaster casting described by Ponseti.
The treatment started for all study participants within 10 days after birth.
Plaster casting procedure:
The children were calmed as far as possible before manipulation and plastering (e.g. by breastfeeding). All manipulations and plaster castings were carried out by two persons (first and second author). First, the cavus foot was corrected by supination of the forefoot until the plantar surface of the foot shows a normal longitudinal arch. Second, we carried out the manipulation: For this, the talus head is localized and then stabilized with the thumb. Then we performed the abduction of the foot in supination as far as the child tolerated and held this position for about 1 minute (see figure 1 b).
Finally, we put on the plaster: To do this, we wrapped the foot up to the knee joint with a thin layer of cotton wool. To apply the plaster, the forefoot is held with the index finger and thumb. The plaster must be modeled over the talus head as long as the foot is held in the corrected position (see figure 1 c). Finally, the plaster is molded, left long on the sole of the foot to support the toes and shortened dorsally to the metatarsophalangeal joints (see figure 1 d).
Figure1_pub.jpg
Figure 1: (a) clubfoot deformity with adduction, equines and supination. The cavus foot component (pes excavatus) is not visible in this clinical picture. (b) Manipulation position, which is held for approximately 1 minute (c) applying the plaster (d) finished plaster
The plaster casting was repeated weekly until the indication for Achilles tenotomy was given. Before applying the final plaster, the clubfoot questionnaire was handed over and the Pirani score was determined again (TE).
Data analysis:
The questionnaires were handed over to the study participants in paper form and, after being answered, transferred into Excel. The further analyses were performed using SPSS‐Statistics (IBM, Version 25.0.0.1).
For group comparison, we performed the non-parametric Wilcoxon test due to the lack of normal distribution (p > 0.05 in the Shapiro-Wilk-test) and data outliners, as well as the Bonferroni method for adjusting p-values in multiple testing (adjusted p-value (padj) = p-value (p) x Number of tests).
For reliability analysis, Cronbach’s alpha (10) was calculated to assess the internal consistency of the five groups (exercise capacity, mental resilience, parents score, motion score, child score). The level of significance was chosen at p <0.05.