- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07694804
Effects of Proprioceptive Neuromuscular Facilitation and Task-Oriented Training on Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy (PNF-TOT-CP)
Isolated Versus Combined Effects of Proprioceptive Neuromuscular Facilitation and Task-Oriented Training on Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy
Children with spastic diplegic cerebral palsy often experience upper extremity impairments, including reduced coordination, muscle control, and functional hand use, which limit independence in daily activities. Proprioceptive Neuromuscular Facilitation (PNF) and Task-Oriented Training (TOT) are commonly used rehabilitation approaches to improve motor function; however, evidence comparing their individual and combined effects on upper extremity function remains limited.
This randomized controlled trial aims to compare the effects of PNF alone, TOT alone, and a combined PNF plus TOT intervention on upper extremity function in children with spastic diplegic cerebral palsy. Sixty-three children aged 6 to 12 years with Gross Motor Function Classification System (GMFCS) levels I to III will be randomly assigned to one of three intervention groups. Each group will receive supervised 45-minute treatment sessions, three times per week for six weeks.
Upper extremity function, functional independence, and joint range of motion will be assessed at baseline, mid-intervention (3 weeks), and post-intervention (6 weeks) using the Melbourne Assessment of Unilateral Upper Limb Function (MA2), Pediatric Evaluation of Disability Inventory-Functional Skills Scale (PEDI-FSS), and goniometric measurements. The findings of this study are expected to provide evidence regarding the most effective rehabilitation approach for improving upper extremity function in children with spastic diplegic cerebral palsy.
연구 개요
상태
상세 설명
Cerebral palsy (CP) is the most common cause of childhood physical disability and is characterized by permanent disorders of movement and posture resulting from non-progressive injury to the developing brain. Although children with spastic diplegic CP primarily present with lower-limb involvement, many also experience impaired upper extremity function, including reduced muscle coordination, impaired selective motor control, weakness, and limitations in reaching, grasping, and object manipulation. These impairments restrict participation in self-care, education, play, and other daily activities.
Task-Oriented Training (TOT) is an evidence-based rehabilitation approach that emphasizes repetitive practice of meaningful, goal-directed functional activities to promote motor learning and improve participation. Proprioceptive Neuromuscular Facilitation (PNF) is another therapeutic approach that enhances neuromuscular activation, proprioceptive input, and coordinated movement patterns through specific diagonal movement techniques. While both interventions have demonstrated beneficial effects in children with cerebral palsy, limited evidence directly compares their isolated and combined effects on upper extremity function in children with spastic diplegic CP.
This study is a three-arm randomized controlled trial designed to compare the effectiveness of PNF alone, TOT alone, and combined PNF plus TOT. A total of 63 children aged 6-12 years with spastic diplegic cerebral palsy (GMFCS levels I-III) will be recruited and randomly allocated to one of the three intervention groups using block randomization.
Participants will receive supervised physiotherapy sessions lasting 45 minutes, three times per week for six weeks. The PNF group will perform upper extremity D1 and D2 diagonal movement patterns. The TOT group will perform structured functional activities including reaching, grasping, releasing, stacking, and object manipulation. The combined intervention group will receive both PNF and TOT within the same treatment session.
Outcome measures will include:
Melbourne Assessment of Unilateral Upper Limb Function (MA2) to assess upper limb movement quality.
Pediatric Evaluation of Disability Inventory-Functional Skills Scale (PEDI-FSS) to evaluate functional independence in self-care.
Goniometric measurements of shoulder, elbow, and wrist range of motion.
Assessments will be performed at baseline, three weeks, and six weeks by trained assessors. Statistical analyses will compare changes within and between groups to determine whether combined therapy provides greater improvements than either intervention alone.
The results of this trial are expected to strengthen the evidence base for pediatric neurorehabilitation and assist clinicians in selecting the most effective physiotherapy approach to improve upper extremity function and functional independence in children with spastic diplegic cerebral palsy.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dr Zahid Mehmood, Master
- 전화번호: 03004615611
- 이메일: zahidmehmood8754@gmail.com
연구 연락처 백업
- 이름: Nauman Khan, Master
- 전화번호: +92 310 5062518
- 이메일: naumankhan5998@gmail.com
연구 장소
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KPK
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Mansehra, KPK, 파키스탄
- 모병
- Helping Hand Institute of Rehabilitation
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연락하다:
- Dr. Pirzada Khattak HOD, PhD
- 전화번호: 0333-2284856
- 이메일: Pirzada.khattak@hhrd.pk
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children aged 6 to 12 years.
- Clinical diagnosis of spastic diplegic cerebral palsy.
- Gross Motor Function Classification System (GMFCS) Levels I-III.
- Ability to understand and follow simple verbal instructions.
- Medically stable and able to participate in physiotherapy sessions.
- Parent or legal guardian willing to provide written informed consent.
Exclusion Criteria:
- Orthopedic surgery involving the upper or lower extremities within the previous 6 months.
- Botulinum toxin injections administered within the previous 6 months.
- Severe visual, hearing, or cognitive impairments that would interfere with assessment or treatment.
- Uncontrolled epilepsy or other unstable neurological or medical conditions.
- Fixed upper extremity contractures or musculoskeletal deformities preventing participation in the intervention.
- Participation in another structured upper extremity rehabilitation program during the study period.
- Failure to obtain informed consent from a parent or legal guardian.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Proprioceptive Neuromuscular Facilitation (PNF)
Participants assigned to this arm will receive Proprioceptive Neuromuscular Facilitation (PNF) exercises targeting the upper extremity.
Treatment will include upper limb diagonal movement patterns (D1 and D2 flexion and extension) to improve neuromuscular control, coordination, muscle activation, and functional movement.
Each participant will receive supervised physiotherapy sessions lasting 45 minutes, three times per week for six weeks.
|
Participants will receive Proprioceptive Neuromuscular Facilitation (PNF) exercises for the upper extremity using diagonal movement patterns (D1 and D2 flexion and extension).
Treatment is designed to facilitate neuromuscular activation, improve muscle strength, coordination, proprioception, and functional upper limb movement.
Each participant will receive supervised 45-minute treatment sessions, three times per week for six weeks.
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실험적: Task-Oriented Training (TOT)
Participants assigned to this arm will receive Task-Oriented Training focused on repetitive, goal-directed functional activities of the upper extremity.
Intervention will include reaching, grasping, releasing, object manipulation, stacking, and other task-specific activities designed to improve upper limb function and functional independence.
Each participant will receive supervised physiotherapy sessions lasting 45 minutes, three times per week for six weeks.
|
Participants will perform structured, goal-directed functional upper extremity activities including reaching, grasping, releasing, object manipulation, stacking, and other task-specific exercises.
The intervention emphasizes repetitive practice of meaningful functional tasks to improve motor control, upper limb function, and independence in daily activities.
Sessions will last 45 minutes, three times per week for six weeks.
|
|
실험적: Combined PNF and Task-Oriented Training
Participants assigned to this arm will receive a combination of Proprioceptive Neuromuscular Facilitation (PNF) and Task-Oriented Training (TOT) during each treatment session.
The intervention will incorporate upper extremity PNF diagonal movement patterns followed by task-specific functional training, including reaching, grasping, releasing, and object manipulation.
Each participant will receive supervised physiotherapy sessions lasting 45 minutes, three times per week for six weeks.
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Participants will receive a combined intervention consisting of Proprioceptive Neuromuscular Facilitation (PNF) followed by Task-Oriented Training (TOT) within the same treatment session.
The intervention integrates upper extremity PNF diagonal movement patterns with repetitive task-specific functional activities to enhance neuromuscular control, motor learning, upper limb function, and functional independence.
Each supervised session will last 45 minutes and will be delivered three times per week for six weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Upper Extremity Function
기간: Baseline, Week 3, and Week 6
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Upper extremity function will be assessed using the Melbourne Assessment of Unilateral Upper Limb Function, Second Edition (MA2).
The MA2 evaluates movement quality, dexterity, accuracy, fluency, and range of motion during functional upper limb tasks.
Higher scores indicate better upper extremity function.
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Baseline, Week 3, and Week 6
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Functional Independence in Activities of Daily Living
기간: Baseline, Week 3, and Week 6
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Functional independence will be assessed using the Pediatric Evaluation of Disability Inventory-Functional Skills Scale (PEDI-FSS).
The instrument measures the child's capability to perform age-appropriate self-care and functional activities.
Higher scores indicate greater functional independence.
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Baseline, Week 3, and Week 6
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Upper Extremity Range of Motion
기간: Baseline, Week 3, and Week 6
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Active range of motion of the shoulder, elbow, and wrist joints will be measured using a standard universal goniometer.
Measurements will be recorded in degrees to evaluate changes in joint mobility following the intervention.
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Baseline, Week 3, and Week 6
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dr Zahid Mehmood, Ibadat International University
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- Ref: IIUI/RERC/ADT/2026/02/240
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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