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临床试验/NCT06076655
NCT06076655Unknown不适用

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

Istanbul Arel University0 个研究点目标入组 15 人开始时间: 2023年10月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
主要终点
GROSS MOTOR FUNCTİON CLASSİFİCATİON SYSTEM

研究概览

简要总结

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.

详细描述

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
  1. Passive thumb abduction with thumb traction from the first metatarsophalangeal joint
  2. Toe Sequential Exercises

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
117 Months 至 201 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

GROSS MOTOR FUNCTİON CLASSİFİCATİON SYSTEM

时间窗: ONLY BEFORE TREATMENT

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.

PARTICIPANT EVALUATION FORM

时间窗: ONLY BEFORE TREATMENT

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.

COMMUNICATION FUNCTION CLASSIFICATION SYSTEM (CFCS)

时间窗: ONLY BEFORE TREATMENT

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.

USE OF ORTHOSES AND ASSISTIVE DEVICES

时间窗: ONLY BEFORE TREATMENT

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.

次要结局

  • VİSUAL ANALOGUE SCALE(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)
  • 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)
  • MODIFIED ASHWORTH 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)

研究者

发起方
Istanbul Arel University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bedia ÖZDEMİR

Physiotherapist

Istanbul Arel University

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