Clinical trial NCT06076655: Hallux Valgus Treatment Developed for Children With Cerebral Palsy
Official title: The Effectiveness of Exercise and Mobilization in Correcting Deformity in Children With Diplegic Cerebral Palsy With Hallux Valgus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hallux Valgus
Keywords: HALLUX VALGUS
CEREBRAL PALSY
EXERCISE
MOBILIZATION
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 15
Sex: ALL
Minimum age (years): 117
Maximum age (years): 201
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a clinical trial.Hallux valgus, one of the common deformities in the foot in children with diplegic Cerebral Palsy, has caused serious problems in daily life activities in children and has usually resulted in surgical operation. Due to the lack of sufficient studies on this topic, our aim in our study is to show the importance of exercise and mobilization applied by physiotherapists in the early stages of hallux valgus deformity, which is common in children with Cerebral palsy, in correcting the deformity, and an example exercise program for physiotherapists.

The study will include 15 individuals with cerebral palsy diagnosed with hallux valgus by a physician at the Physiotherapy and Rehabilitation clinic at Istanbul FSM Madenler Medical Center according to the following criteria. Children diagnosed with diplegic SP, aged 9-16, with Communication Function Classification System Levels 1 and 2, ambulation level GMFCS 1-2, using AF Dec and GRAPHO and without any auxiliary device use, Manchester scale stages 1 and 2 will be included. Those who cannot walk independently, GMSCS 3 and above, children using assistive devices, Communication Function Classification System Level 3 and above, children with Manchester scale Stage 3 hallux valgus will be excluded from the study.Manchester November Scale for Hallux valgus classification, Hallux valgus angle and Foot and Ankle joint range of motion goniometer, Spasticity Modified Ashworth Scale (MAS), Foot and Ankle muscle strength Kendall Manual Muscle Strength Assessment, Pain Visual Analogue Scale (VAS), Communication skill Communication Function Classification System with Gross Motor Function Classification System GMFCS level, American orthopedic foot-ankle association-hallux MTF-IF scale evaluation is planned.

Detailed description: EXERCISE PROGRAM The Hallux Valgus exercise program determined by the physiotherapist will be performed twice a week in the rehabilitation unit accompanied by a physiotherapist, each exercise and mobilization will be planned as 2 sets of 10 repetitions and 15 seconds between sets, and will be performed for 12 weeks Dec. In addition, home exercises will be given 2 times a day and each exercise will be followed by 10 repetitions for 2 sets and 15 seconds Dec between sets.

The exercise and mobilization program planned to be implemented in this study for children with diplegic Cerebral Palsy is an exercise and mobilization program that has shown positive results in adults in various studies. We have created an exemplary protocol with the exercise and mobilization practices that were found effective in these studies. Below is our sample program.

Exercise and mobilization program to be implemented in the clinic accompanied by a physiotherapist:

1. 1. Metatarsophalangeal Joint (MTFE) mobilization

   * 1. MTF Traction mobilization
   * 1. MTF medial and lateral shift mobilization
   * 1. MTF dorso-plantar mobilization
   * 1. MTF sesamoid mobilization
2. Passive thumb abduction with thumb traction from the first metatarsophalangeal joint
3. Toe Sequential Exercises

   * 1. Phase: Bringing all the fingers into extension without breaking the contact of the heel and metatarsal heads with the ground.
   * 2. Phase: While the other fingers are still in extension, the smallest finger is moved laterally and flexibly to make contact with the ground again.
   * 3. Phase: Ensuring contact with the ground by slowly and controllably bringing the thumb into abduction and flexion while the other fingers maintain the position they took last
4. Active thumb abduction
5. Thumb abduction exercise with toe toe exercise rubber
6. The movement of collecting sheets for active flexion of the ind November muscles of the foot
7. Ball rolling exercise on the sole of the foot
8. Active stretching exercise of the gastro-soleus November
9. Hamstring November muscle active stretching exercise (Rose et al., 2020; Okur et al., 2019; Kim M-H et al.,2015)

Home exercise program to be given to the patient:

1. Toe Sequential Exercises

   * 1. Phase: Bringing all the fingers into extension without breaking the contact of the heel and metatarsal heads with the ground.
   * 2. Phase: While the other fingers are still in extension, the smallest finger is moved laterally and flexibly to make contact with the ground again.
   * 3. Phase: Ensuring contact with the ground by slowly and controllably bringing the thumb into abduction and flexion while the other fingers maintain the position they took last
2. Active thumb abduction
3. Thumb abduction exercise with Toe Toe Exercise Rubber
4. The movement of collecting sheets for active flexion of the ind November muscles of the foot
5. Ball rolling exercise on the sole of the foot
6. Active stretching exercise of the gastro-soleus November
7. Hamstring November muscle active stretching exercise

Evaluations will be performed 3 times before treatment, in the middle of treatment and at the end of treatment.

Exercise and mobilization performed alone as a result of treatment will prevent hallux valgus of seals in children with diplegic cerebral palsy, prevent surgical operation and provide an exemplary exercise protocol to physiotherapists.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with cerebral palsy,
* Being a spastic diplegic type of cerebral palsy,
* Age range 9-16,
* Communication Function Classification System Level 1 and 2,
* Children with ambulatory level GMFCS 1-2,
* Using AFO and GRAFO,
* Children who do not use any assistive devices,
* Children with Manchester scale Stage 1 and 2 hallux valgus will be included in the study.

Exclusion Criteria:

* Those who cannot walk independently,
* GMSCS 3 and above,
* Does not use AFO and GRAFO,
* Children using assistive devices,
* Communication Function Classification System Level 3 and above,
* Manchester scale stage 3 hallux valgus,
* Children with spasticity values above 1+ according to the Modified Ashworth Scale will be excluded from the study.

Primary outcomes:
measure: COMMUNICATION FUNCTION CLASSIFICATION SYSTEM (CFCS)
timeFrame: ONLY BEFORE TREATMENT
measure: GROSS MOTOR FUNCTİON CLASSİFİCATİON SYSTEM
timeFrame: ONLY BEFORE TREATMENT
measure: USE OF ORTHOSES AND ASSISTIVE DEVICES
timeFrame: ONLY BEFORE TREATMENT
measure: PARTICIPANT EVALUATION FORM
timeFrame: ONLY BEFORE TREATMENT
Secondary outcomes:
measure: MANCHESTER SCALE
timeFrame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
measure: HALLUX VALGUS ANGLE
timeFrame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
measure: KENDALL MANUAL MUSCLE STRENGTH ASSESSMENT
timeFrame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
measure: VİSUAL ANALOGUE SCALE
timeFrame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
measure: AMERICAN ORTHOPEDIC FOOT-ANKLE ASSOCIATION HALLUX INTERPHALANGEAL JOINT SCALE
timeFrame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
measure: MODIFIED ASHWORTH SCALE
timeFrame: BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Arel University
name: BEDİA ÖZDEMİR
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Arel University
name: SEÇİL ÖZKURT
role: STUDY_CHAIR
affiliation: Istanbul Arel University
name: OLCAY GÜLER
role: STUDY_CHAIR
References:
citation: Kim MH, Yi CH, Weon JH, Cynn HS, Jung DY, Kwon OY. Effect of toe-spread-out exercise on hallux valgus angle and cross-sectional area of abductor hallucis muscle in subjects with hallux valgus. J Phys Ther Sci. 2015 Apr;27(4):1019-22. doi: 10.1589/jpts.27.1019. Epub 2015 Apr 30.