- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07595744
Sensory Walkway and Gait in Children With Diplegic Cerebral Palsy (SWGCP)
Effect of Sensory Walkway on Gait Parameters in Children With Diplegic Cerebral Palsy
연구 개요
상태
상세 설명
This study will be conducted after approval from the Ethical Committee of the Faculty of Physical Therapy, Cairo University, and will follow the ethical principles of the Declaration of Helsinki. Written informed consent will be obtained from the parents of all participating children.
The intervention involves the use of a structured sensory walkway composed of eight wooden foot boxes filled with different textured materials, including polyester fiberfill, cut plastic straws, foam beads, and kinetic sand. This setup is designed to provide continuous multimodal tactile stimulation during gait training to enhance sensory-motor integration, postural control, and gait performance. Children in the intervention group will perform reciprocal gait training while interacting with the sensory surfaces, accompanied by verbal feedback to facilitate sensory awareness and motor engagement.
Both groups will receive a traditional physical therapy program including stretching exercises, quadruped and kneeling activities, balance training, stepper exercises, and gait training on various surfaces and equipment.
Data will be analyzed using descriptive statistics (mean and standard deviation), and statistical analysis will be performed using IBM SPSS software.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Shaymaa Rushdy Mahmoud, lecturer
- 전화번호: 0201145050053
- 이메일: shaymaa.rushdy@pt.cu.edu.eg
연구 장소
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Giza Governorate
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Dokki, Giza Governorate, 이집트
- 모병
- outpatient clinic, faculty of physical therapy, Cairo university
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연락하다:
- Shaymaa Rushdy Mahmoud, lecturer
- 전화번호: 0201145050053
- 이메일: shaymaa.rushdy@pt.cu.edu.eg
-
부수사관:
- Shaymaa Rushdy Mahmoud, Lecturer of Physical Therapy
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Clinical diagnosis of spastic diplegic cerebral palsy
- Aged between 5 and 7 years
- Classified at level II on the Gross Motor Function Classification System
- Spasticity grade 1 or 1+ according to the Modified Ashworth Scale
- Able to walk independently or with an assistive device without physical assistance
- Able to follow verbal commands
- Abnormal gait pattern
Exclusion Criteria:
- Visual or auditory impairment
- History of lower limb surgery within the past 2 years
- Use of medications affecting muscle tone and/or cognitive function
- Contractures or fixed deformities in upper or lower limbs
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Control Group - Conventional Physical Therapy
Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training.
The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices.
Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.
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Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training.
The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices.
Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.
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실험적: Study Group - Conventional Physical Therapy plus Sensory Walkway Training
Participants in the study group will receive conventional physical therapy including stretching, strengthening, balance exercises, and gait training.
In addition, they will undergo gait training on a sensory walkway consisting of wooden foot boxes filled with different textured materials to provide tactile stimulation.
Corresponding hand sensory boxes are placed along parallel bars to provide simultaneous upper limb sensory input.
Children will walk through the walkway while immersing their feet and hands in the textured materials and are encouraged to identify and describe textures to enhance sensory awareness.
The intervention aims to improve sensory-motor integration, postural control, balance, and gait parameters in children with spastic diplegic cerebral palsy.
Each session lasts 60 minutes and is performed three times per week for three months.
|
Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training.
The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices.
Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.
Participants in the study group will receive conventional physical therapy in addition to gait training on a sensory walkway.
The sensory walkway consists of a sequence of wooden foot boxes filled with different textured materials to provide tactile stimulation of the feet during walking.
Corresponding hand sensory boxes are placed along parallel bars to provide simultaneous upper limb sensory input.
This setup enables reciprocal sensory stimulation of upper and lower limbs during gait training.
Children will walk through the walkway in a controlled manner while immersing their feet and hands in the textured materials and are encouraged to identify and describe the textures to enhance sensory awareness.
The intervention aims to improve sensory-motor integration, postural control, balance, and gait parameters in children with spastic diplegic cerebral palsy.
Each session lasts 60 minutes and is performed three times per week for three months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gait Speed
기간: 3 months
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Gait speed (m/s) will be assessed using the 10-Meter Walk Test (10MWT).
Participants will walk a 10-meter distance at a self-selected comfortable walking speed.
Time recorded during the test will be used only to calculate gait speed.
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Step Width
기간: 3 months
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Step width (cm) will be assessed using Kinovea software based on video recordings.
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3 months
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Cadence
기간: 3 months
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Cadence (steps/min) will be calculated using gait cycle analysis from Kinovea software
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3 months
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Step Time
기간: 3 months
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Step time (seconds) will be analyzed using Kinovea software based on video-based gait cycle timing.
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3 months
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- No:P.T.REC/012/006158
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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