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Constraint-induced Movement Therapy Combined With Functional Electrical Stimulation in Children With Cerebral Palsy (CIMT-FES-CP)

2026년 5월 14일 업데이트: Montiha Azeem
This randomized controlled trial aims to compare the effectiveness of Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) versus CIMT alone in improving upper limb function, reducing spasticity, and enhancing functional independence in children with cerebral palsy (CP). A total of 46 children aged 3 to 15 years with spastic or dyskinetic cerebral palsy will be recruited from rehabilitation centers and hospitals in Sukkur, Pakistan. Participants will be randomly assigned into two groups: Group A will receive CIMT combined with FES, while Group B will receive CIMT alone. Both groups will undergo supervised therapy sessions five times per week for six weeks. Outcomes will be assessed before and after treatment using the Modified Ashworth Scale (MAS), Melbourne Assessment of Unilateral Upper Limb Function (MUUL), and Pediatric Evaluation of Disability Inventory (PEDI). The study aims to determine whether combining FES with CIMT provides greater improvements in motor recovery and daily functional performance in children with CP.

연구 개요

상세 설명

Cerebral palsy (CP) is one of the most common neurological disorders in children and is frequently associated with impaired upper limb function, spasticity, reduced motor control, and limitations in performing activities of daily living. Children with spastic and dyskinetic CP often experience difficulty in reaching, grasping, releasing, and manipulating objects, which negatively affects their independence and participation in daily activities. Various rehabilitation approaches have been developed to improve upper limb performance in children with CP, among which Constraint-Induced Movement Therapy (CIMT) has shown promising results in promoting cortical reorganization and functional use of the affected extremity.

CIMT is based on restraining the less affected upper limb to encourage intensive use of the affected limb through repetitive and task-oriented activities. Although CIMT has demonstrated effectiveness in improving motor outcomes, some children still exhibit limited voluntary muscle activation and persistent spasticity that may reduce the overall effectiveness of therapy. Functional Electrical Stimulation (FES) has emerged as an adjunctive rehabilitation technique that may facilitate neuromuscular activation, improve motor learning, and enhance voluntary movement by delivering low-level electrical impulses to targeted muscles.

The present study is designed to investigate the comparative effectiveness of CIMT combined with FES versus CIMT alone in children with cerebral palsy. The study will focus on evaluating changes in spasticity, upper limb function, and functional independence following a six-week intervention program. Participants will be randomly assigned into two treatment groups. Group A will receive CIMT combined with FES, while Group B will receive CIMT alone. Both groups will receive therapy sessions five times per week under the supervision of trained physiotherapists.

Outcome measures will include the Modified Ashworth Scale (MAS) for assessment of spasticity, the Melbourne Assessment of Unilateral Upper Limb Function (MUUL) for evaluation of upper limb motor performance, and the Pediatric Evaluation of Disability Inventory (PEDI) for assessment of functional independence. Assessments will be conducted before and after the intervention period to determine treatment effectiveness.

The findings of this study may contribute to evidence-based pediatric neurorehabilitation by identifying whether the addition of FES to CIMT provides superior therapeutic benefits compared to CIMT alone. The study may also help clinicians develop more effective rehabilitation protocols aimed at improving motor recovery, independence, and quality of life in children with cerebral palsy.

연구 유형

중재적

등록 (추정된)

46

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Punjab Province
      • Lahore, Punjab Province, 파키스탄, 54000

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

Children aged 3 to 15 years, including both male and female population. Diagnosed with cerebral palsy (CP), confirmed by medical assessment and clinical evaluation.

Moderate to severe impairment in upper limb function (as determined by a relevant motor function assessment scale, e.g., the Modified Ashworth Scale.

Children with spastic and dyskinetic types of cerebral palsy. Children with cognitive ability that allows for participation in therapy, as determined by minimental status examination.

No history of recent interventions (e.g., surgery, Botox injections) that may interfere with study participation.

Exclusion Criteria:

Children with contraindications to functional electrical stimulation (e.g., pacemaker, skin conditions, or open wounds in the area of electrode placement).

Presence of other significant neurological or musculoskeletal disorders that could confound the results (e.g., traumatic brain injury, muscular dystrophy)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: group A CIMT Combined with FES Group
Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) for the affected upper limb. Therapy will be conducted five sessions per week for six weeks, with each session lasting 60 minutes. CIMT will involve restraining the unaffected upper limb using a mitt or sling to encourage use of the affected limb during task-oriented activities such as reaching, grasping, releasing, drawing, stacking, and object manipulation. Functional Electrical Stimulation will be applied to targeted upper limb muscles including wrist extensors and finger muscles using therapeutic stimulation parameters to facilitate voluntary motor control and neuromuscular re-education.
This intervention combines Constraint-Induced Movement Therapy (CIMT) with Functional Electrical Stimulation (FES) for rehabilitation of the affected upper limb in children with cerebral palsy. The unaffected upper limb will be restrained using a mitt or sling to encourage active use of the affected limb during repetitive, task-oriented activities such as reaching, grasping, stacking, drawing, and object manipulation. Functional Electrical Stimulation will be applied to selected upper limb muscles including wrist extensors and finger muscles using therapeutic electrical stimulation parameters (pulse width 200-300 microseconds, frequency 35-50 Hz, and on-off cycle of 10 seconds on and 20 seconds off). The intervention will be delivered for 60 minutes per session, five sessions per week, for six weeks under physiotherapist supervision.
활성 비교기: group B CIMT Alone Group
Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) alone for six weeks, five sessions per week, with each session lasting 60 minutes. The unaffected upper limb will be restrained using a mitt or sling to encourage repetitive use of the affected upper limb during functional and task-specific activities. Activities will include self-care tasks, play-based exercises, grasp and release training, drawing, stacking blocks, and object handling exercises tailored to the child's functional level. No electrical stimulation will be administered in this group.
Constraint-Induced Movement Therapy (CIMT) will be provided to improve upper limb function in children with cerebral palsy by encouraging repetitive use of the affected extremity. The unaffected upper limb will be restrained using a mitt or sling while children perform structured, task-specific activities including grasping, reaching, releasing, drawing, feeding-related activities, stacking blocks, and play-based functional tasks. Therapy sessions will last 60 minutes each, five times per week for six weeks, with progression in task difficulty according to the child's functional abilities. No electrical stimulation will be applied in this intervention.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Upper Limb Function Using Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
기간: 3 weeks and after 6 weeks of intervention
Upper limb function will be assessed using the Melbourne Assessment of Unilateral Upper Limb Function (MUUL), which evaluates the quality of unilateral upper extremity movement including reach, grasp, release, and object manipulation in children with cerebral palsy. Higher scores indicate better upper limb motor performance and functional ability.
3 weeks and after 6 weeks of intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Muhammad Hafeezullah Tariq, MSPPT, The University of Lahore, Lahore

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 18일

기본 완료 (추정된)

2026년 6월 28일

연구 완료 (추정된)

2026년 6월 29일

연구 등록 날짜

최초 제출

2026년 5월 7일

QC 기준을 충족하는 최초 제출

2026년 5월 7일

처음 게시됨 (실제)

2026년 5월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 14일

마지막으로 확인됨

2026년 5월 1일

추가 정보

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아니

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. .

뇌성마비(CP)에 대한 임상 시험

Constraint-Induced Movement Therapy Combined with Functional Electrical Stimulation에 대한 임상 시험

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