- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07827365
VR Versus Task-Oriented Circuit Training on UL Sensorimotor in Children With Immature Brain Injury
Effect of Virtual Reality Versus Task-Oriented Circuit Training on Upper Limb Sensorimotor Function in Children With Immature Brain Injury :Randomized Controlled Trial
연구 개요
상세 설명
To investigate and compare the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with with immature brain injury. BACKGROUND: Children with immature brain injury may have limited use of their hands for functional activities and for fine motor skills. The primary function of the hand is hand grip, which has a great Influence on activities and tasks of daily life
Hypothesis
This study hypothesized that:
there is no difference between the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with spastic cerebral palsy.
RESEARCH QUESTION:
Is there difference between the effect of virtual reality and task-oriented circuit training on pinch grip and quality of life in children with immature brain injury?
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Lama Saad El-Din SED Mahmoud
- 전화번호: 01157592636
- 이메일: lamaelsedawyy@hotmail.com
연구 연락처 백업
- 이름: Lama Saad El-Din SED Mahmoud
- 전화번호: 00201157592636
- 이메일: lamaelsedawyy@hotmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Forty four children with cerebral palsy,
- Age will range as (12:18) years old
- spastic cerebral palsy
- Gross motor function classification system: level I&II
- level I-III on the Manual Ability Classification System (MACS)
Exclusion Criteria:
- difficulty to communicate or to understand program instructions
- surgery/Botox injection during the last 6 months in the upper extremity
- uncontrolled severe seizures
- fixed deformities in the affected side;
- Attention deficit/hyperactivity disorders.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Virtual reality (VR)
Virtual reality (VR) will be applied as an interactive, task-oriented rehabilitation intervention targeting upper-extremity function.
Participants will perform virtual tasks involving purposeful reaching, grasping, object manipulation, and directional movements of the affected upper limb.
The difficulty and range of the tasks will be progressively adjusted according to each participant's functional ability to encourage active movement, repetitive practice, and motor learning.
|
Virtual reality (VR) will be applied as an interactive, task-oriented rehabilitation intervention targeting upper-extremity function.
Participants will perform virtual tasks involving purposeful reaching, grasping, object manipulation, and directional movements of the affected upper limb.
The difficulty and range of the tasks will be progressively adjusted according to each participant's functional ability to encourage active movement, repetitive practice, and motor learning.
다른 이름들:
|
|
실험적: Task-oriented circuit training
Task-oriented circuit training will be provided to improve upper-extremity functional performance through repetitive, goal-directed activities.
Participants will perform a series of functional tasks involving reaching, grasping, lifting, transferring, and manipulating objects.
The training will be organized as a circuit of exercise stations, with each station targeting a specific upper-extremity functional skill.
Tasks will be progressively modified by increasing the movement complexity, speed, repetitions, or task demands according to the participant's functional ability.
Participants will receive verbal instructions and feedback from the physiotherapist to facilitate accurate task performance and encourage active participation.
|
Task-oriented circuit training will be provided to improve upper-extremity functional performance through repetitive, goal-directed activities.
Participants will perform a series of functional tasks involving reaching, grasping, lifting, transferring, and manipulating objects.
The training will be organized as a circuit of exercise stations, with each station targeting a specific upper-extremity functional skill.
Tasks will be progressively modified by increasing the movement complexity, speed, repetitions, or task demands according to the participant's functional ability.
Participants will receive verbal instructions and feedback from the physiotherapist to facilitate accurate task performance and encourage active participation.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pinch dynamometer
기간: three months
|
Pinch strength will be assessed using a pinch dynamometer to quantify the maximal voluntary pinch force of the affected hand.
The dynamometer will be positioned between the thumb and the specified finger(s), and participants will be instructed to apply maximal pinch force for approximately 3-5 seconds.
Three trials will be performed with adequate rest between trials, and the highest recorded value or mean of the three trials will be used for analysis.
|
three months
|
|
fugl myer assessment for sensorimotor function of upper limb
기간: three months
|
The Fugl-Meyer Assessment (FMA) will be used to evaluate sensorimotor function of the upper extremity.
The upper-extremity section of the FMA will assess motor function, reflex activity, coordination, and speed of movement.
The assessment will include movements of the shoulder, elbow, forearm, wrist, and hand, with each item scored according to the standardized FMA scoring system.
Higher scores will indicate better sensorimotor performance of the affected upper extremity
|
three months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pediatric Quality of Life Inventory CP Module
기간: three months
|
The Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL CP Module) will be used to assess health-related quality of life in children with cerebral palsy.
The questionnaire will evaluate the child's perceived difficulties and limitations across cerebral palsy-specific domains, including daily activities, movement and balance, pain and hurt, fatigue, eating activities, and communication, as applicable to the child's age and functional level.
Items will be scored according to the standardized PedsQL CP Module scoring system, with higher scores indicating better health-related quality of life.
|
three months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .