Hallux Valgus Treatment Developed for Children With Cerebral Palsy

NCT06076655 | Unknown DMC

• 1 other identifier: IstanbulArelUBediaozdemir
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hallux Valgus

Keywords

HALLUX VALGUS; CEREBRAL PALSY; EXERCISE; MOBILIZATION

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• MANCHESTER SCALE

  BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT

• HALLUX VALGUS ANGLE

  BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT

• KENDALL MANUAL MUSCLE STRENGTH ASSESSMENT

  BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT

• VİSUAL ANALOGUE SCALE

  BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT

• AMERICAN ORTHOPEDIC FOOT-ANKLE ASSOCIATION HALLUX INTERPHALANGEAL JOINT SCALE

  BEFORE TREATMENT ,MIDDLE OF TREATMENT, AT THE END OF TREATMENT

Interventions

EXERCISE AND MOBILIZATION PROGRAM OTHER

EXERCISE AND MOBILIZATION PROGRAM The Hallux Valgus exercise program determined by the physiotherapist will be applied twice a week in the rehabilitation unit under the supervision of a physiotherapist. Each exercise and mobilization will be planned as 2 sets of 10 repetitions and 15 seconds between sets, and will be carried out throughout the interval for 12 weeks. In addition, home exercises will be given twice a day, and each exercise will be followed in 2 sets of 10 repetitions with a 15-second interval 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 yielded positive results in various studies in adults. We created a sample protocol with exercise and mobilization practices that were found effective in these studies.

Eligibility Criteria

• Age: 117 Months - 201 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Arel University: lead

Related Publications (1)

• 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.

  PMID: 25995546 BACKGROUND

Related 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

MeSH Terms

Conditions

Hallux Valgus; Cerebral Palsy; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• BEDİA ÖZDEMİR

  Istanbul Arel University

  PRINCIPAL INVESTIGATOR

• SEÇİL ÖZKURT

  Istanbul Arel University

  STUDY CHAIR

• OLCAY GÜLER

  Istanbul Arel University

  STUDY CHAIR

Central Study Contacts

BEDİA ÖZDEMİR

CONTACT

+905439422765; fzt.bediaozdemir@gmail.com

SEÇİL ÖZKURT

CONTACT

+905326664244; secilozkurt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 11, 2023
• Study Start: October 2, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Dec January October 2023 to January 2024 is planned for our study.
• Access Criteria: * Magazine editor * Members of the ethics committee