Hallux Valgus Treatment Developed for Children With Cerebral Palsy

The Effectiveness of Exercise and Mobilization in Correcting Deformity in Children With Diplegic Cerebral Palsy With Hallux Valgus

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hallux Valgus
• Intervention / Treatment: Other: EXERCISE AND MOBILIZATION PROGRAM

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BEDİA ÖZDEMİR; Phone Number: +905439422765; Email: fzt.bediaozdemir@gmail.com
• Study Contact Backup: Name: SEÇİL ÖZKURT; Phone Number: +905326664244; Email: secilozkurt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COMMUNICATION FUNCTION CLASSIFICATION SYSTEM (CFCS)	The aim of the communication function classification system is to classify daily communication performance between I and V levels in individuals with Cerebral Palsy.Dec.This classification is carried out with a form.Our aim is to include individuals who can express themselves in our study. Level 1 represents the effective receiver and transmitter with familiar and foreign partners, level 5 rarely represents the effective transmitter and receiver, even with familiar partners.	ONLY BEFORE TREATMENT
GROSS MOTOR FUNCTİON CLASSİFİCATİON SYSTEM	Gross motor function in children with cerebral palsy is a standardized method that classifies motor function differences, especially in sitting and walking, into 5 levels. Level I walks without restriction; Level II walks with restrictions; Level III walks using hand-held mobility devices; Level IV, independent self-mobility limited and may use motorized mobility device; Level V is transported in a hand-propelled wheelchair.	ONLY BEFORE TREATMENT
USE OF ORTHOSES AND ASSISTIVE DEVICES	A crıterıa has been prepared to questıon ıf there ıs an orthosıs ın the lower extremıtıty that chıldren wıth cerebral palsy use ın daıly lıfe, ıf any, what type of orthoses ıt ıs, and ıf they use assıstıve devıces.	ONLY BEFORE TREATMENT
PARTICIPANT EVALUATION FORM	The sociodemographic characteristics of the children were recorded and information such as name, surname, age, height, weight, gender, and body mass index were questioned. Factors causing the disease, accompanying diseases and extremity involvement are determined and recorded in the evaluation form.	ONLY BEFORE TREATMENT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MANCHESTER SCALE	This scale, which was developed to determine the degree of hallux valgus deformity in individuals; It is considered at 4 levels: none (1), mild (2), moderate (3), and severe (4) and is used as a clinical tool that includes photographs of the foot.Measurements were made 3 times before starting treatment, in the middle of treatment and at the end of treatment.	BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
HALLUX VALGUS ANGLE	Measurements will be made using a universal goniometer. The first metatarsophalangeal joint was determined as the pivot point, and one arm of the goniometer was placed parallel to the articular joint. The first metatarsal bone is parallel to the proximal phalanx of the other arm and the hallux angle is recorded in degrees. Individuals with a toe hallux angle over 15 degrees are considered to have Hallux valgus. Measurements were taken 3 times before starting treatment, in the middle of treatment and at the end of treatment.	BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
KENDALL MANUAL MUSCLE STRENGTH ASSESSMENT	It will be used to evaluate November's muscle strength in children. This Test is scored Decently between 0 and 5.0 is the worst, 5 gives the best value. November November, the muscle groups to be evaluated were; MTF Flexion and Extension, IF Flexion and IF Extension Abduction of the big toe, plantar flexion of the ankle, dorsiflexion, eversion and inversion muscle groups were applied. Each assessment was repeated three times and the average was taken.	BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
VİSUAL ANALOGUE SCALE	It is used to evaluate possible change in pain intensity. It will be reported as no pain (0) and the worst pain imaginable (10). And the subjects will be asked to mark their pain at rest. Then, the marks on this line will be measured in centimeters and the results will be recorded. Measurements were taken 3 times before starting treatment, in the middle of treatment and at the end of treatment.	BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
AMERICAN ORTHOPEDIC FOOT-ANKLE ASSOCIATION HALLUX INTERPHALANGEAL JOINT SCALE	This 100-point scale is used to evaluate subjective and objective factors. Pain is evaluated as 40 points; function is evaluated as 45 points and alignment is evaluated as 15 points for a total of 100 points. If the patient has bilateral deformity, the result characteristics indicating the foot problem are recorded separately for both feet.Measurements were made 3 times before starting treatment, in the middle of treatment and at the end of treatment.	BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT
MODIFIED ASHWORTH SCALE	Modified Ashworth Scale (MAS) is used for spasticity. Hip Flexors, Hip Adductors, Rectus Femoris and hamstring muscle groups, Foot-ankle plantar flexion and dorsiflexion will be evaluated while the children lie on their backs in a comfortable position in bed. MAS is a 6-point scale that evaluates muscle tone. 0: No increase in tone and 4: Indicates that the involved part is rigid in flexion or extension. Measurements were made 3 times before starting treatment, in the middle of treatment and at the end of treatment.	BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT

Collaborators and Investigators

• Sponsor: Istanbul Arel University
• Investigators: Principal Investigator: BEDİA ÖZDEMİR, Istanbul Arel University; Study Chair: SEÇİL ÖZKURT, Istanbul Arel University; Study Chair: OLCAY GÜLER, Istanbul Arel University

Publications and helpful links

General Publications

• 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.

Helpful Links

• The effects of taping and foot exercises on patients with hallux valgus: a preliminary study
• EVALUATION OF THE EFFICACY OF MANUAL MOBILIZATION TECHNIQUES IN THE TREATMENT OF HALLUX RIGIDUS: CASE SERIES

Study record dates

Study Major Dates

• Study Start (Estimated): October 2, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: October 1, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: CEREBRAL PALSY; EXERCISE; HALLUX VALGUS; MOBILIZATION
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Cerebral Palsy; Hallux Valgus; Bunion
• Other Study ID Numbers: IstanbulArelUBediaozdemir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is planned that our individual participant data will be shared by mail with people who meet the appropriate Access Criteria.
• IPD Sharing Time Frame: Dec January October 2023 to January 2024 is planned for our study.
• IPD Sharing Access Criteria: Magazine editor; Members of the ethics committee
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No