- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07734376
Mirror Therapy in Children With Hemiparetic Cerebral Palsy
Effects of Mirror Therapy on Upper Extremity Function and Motor Control in Children With Hemiparetic Cerebral Palsy
Cerebral palsy (CP) is a neurodevelopmental disorder that frequently impairs upper extremity motor control and hand function, resulting in limitations in daily activities. Mirror therapy is a low-cost, easy-to-implement intervention that promotes motor learning by stimulating cortical reorganization and neuroplasticity. This randomized, sham-controlled clinical trial aims to investigate the effects of mirror therapy on upper extremity function, selective motor control, hand function, hand grip strength, and manual dexterity in children with hemiparetic CP.
Twenty-six children with hemiparetic CP will be randomly assigned to either an experimental group receiving mirror therapy combined with conventional physiotherapy or a control group receiving sham mirror therapy combined with the same conventional physiotherapy program. The intervention will be administered over an 8-week period.
Baseline assessments will include the Manual Ability Classification System (MACS) and the Modified Ashworth Scale. Outcome measures collected before and after the intervention will include the Selective Control of the Upper Extremity Scale (SCUES), ABILHAND-Kids questionnaire, hand grip strength measured with the Jamar dynamometer, and manual dexterity assessed using the Nine-Hole Peg Test.
The study is expected to provide evidence regarding the effectiveness of mirror therapy beyond conventional physiotherapy by using a sham-controlled design and to contribute to the development of standardized, evidence-based rehabilitation protocols for improving upper extremity function in children with hemiparetic CP.
연구 개요
상태
상세 설명
Cerebral palsy (CP) is a non-progressive neurodevelopmental disorder resulting from injury to the developing brain and is characterized by impairments in movement, posture, and motor function. Children with hemiparetic CP commonly experience unilateral upper extremity weakness, impaired selective motor control, reduced hand function, decreased grip strength, and limitations in activities of daily living. These impairments negatively affect functional independence and quality of life.
Mirror therapy is a low-cost, non-invasive rehabilitation approach based on the principles of neuroplasticity and motor learning. By creating the visual illusion that the affected upper limb is moving normally through the reflection of the unaffected limb, mirror therapy is thought to enhance cortical activation and facilitate motor recovery. Although originally developed for phantom limb pain, mirror therapy has been increasingly applied in neurological rehabilitation and has demonstrated promising effects on upper extremity function.
Several studies have investigated mirror therapy in children with cerebral palsy and reported improvements in hand function and motor performance. However, considerable variation exists in treatment protocols, including intervention duration, exercise content, and comparison groups, limiting the generalizability of the findings. In addition, few studies have incorporated a sham-controlled design, making it difficult to distinguish the specific therapeutic effects of mirror therapy from nonspecific treatment effects.
The present randomized, sham-controlled clinical trial aims to evaluate the effectiveness of mirror therapy combined with conventional physiotherapy in children with hemiparetic CP. Participants will be randomly assigned to either an experimental group receiving mirror therapy in addition to conventional physiotherapy or a control group receiving sham mirror therapy together with the same conventional physiotherapy program.
Upper extremity outcomes will be evaluated before and after an 8-week intervention period using validated assessment tools, including the Selective Control of the Upper Extremity Scale (SCUES), ABILHAND-Kids questionnaire, hand grip strength measured with a Jamar dynamometer, and manual dexterity assessed with the Nine-Hole Peg Test. Baseline motor ability and muscle tone will be documented using the Manual Ability Classification System (MACS) and the Modified Ashworth Scale.
This study is expected to provide higher-quality evidence regarding the effectiveness of mirror therapy by using a standardized intervention protocol and a sham-controlled design. The findings may contribute to the development of evidence-based rehabilitation strategies aimed at improving upper extremity motor control, hand function, and functional independence in children with hemiparetic CP.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: İrem Çetinkaya, PhD
- 전화번호: 5548056805
- 이메일: iremkaranki@gmail.com
연구 연락처 백업
- 이름: Emine Kılıç
- 전화번호: 5304936253
- 이메일: fzt.eminekilic@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Diagnosis of hemiparetic cerebral palsy
- Aged between 6 and 12 years
- Manual Ability Classification System (MACS) level I-III
- Having received or currently receiving physiotherapy and rehabilitation for at least 6 months
Exclusion Criteria:
- Cognitive or communication impairments that would prevent participation in mirror therapy.
- Inability to cooperate with the assessment or intervention procedures.
- Presence of uncontrolled neurological disorders, such as epilepsy.
- Musculoskeletal deformities or a history of upper extremity surgery.
- Visual or hearing impairments that would interfere with participation in mirror therapy.
- Receipt of upper extremity interventions other than routine physiotherapy (e.g., botulinum toxin injection or surgical intervention) within the past 6 months.
Inability to comply with the study assessment or intervention schedule.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Mirror Group
Participants assigned to the experimental group will receive an individualized neurodevelopmental treatment-based conventional physiotherapy program combined with mirror therapy, twice weekly for 8 weeks.
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Mirror therapy will be administered for approximately 20 minutes following conventional physiotherapy sessions, twice weekly for 8 weeks.
During the intervention, participants will perform bilateral, symmetrical upper extremity movements while observing the mirror reflection of the unaffected upper limb to create the visual illusion of movement of the affected limb.
Individualized neurodevelopmental treatment-based physiotherapy including stretching, upper extremity strengthening exercises, mat activities, standing and gait training, and fine motor skill activities.
The program will be delivered for approximately 40 minutes per session, twice weekly for 8 weeks.
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가짜 비교기: Control Group
Participants assigned to the control group will receive the same individualized neurodevelopmental treatment-based conventional physiotherapy program combined with sham mirror therapy, twice weekly for 8 weeks.
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Individualized neurodevelopmental treatment-based physiotherapy including stretching, upper extremity strengthening exercises, mat activities, standing and gait training, and fine motor skill activities.
The program will be delivered for approximately 40 minutes per session, twice weekly for 8 weeks.
Sham mirror therapy will be administered for approximately 20 minutes following conventional physiotherapy sessions, twice weekly for 8 weeks.
Participants will perform the same bilateral upper extremity exercises while the mirror is positioned to eliminate visual mirror feedback.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Selective Motor Control of the Upper Extremity
기간: Baseline and after the 8-week intervention
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Selective motor control of the affected upper extremity will be assessed using the Selective Control of the Upper Extremity Scale (SCUES).
The scale evaluates selective voluntary movement at the shoulder, elbow, forearm, wrist, and fingers.
Higher scores indicate better selective motor control.
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Baseline and after the 8-week intervention
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Change in Manual Dexterity
기간: Baseline and after the 8-week intervention
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Manual dexterity will be assessed using the Nine-Hole Peg Test (9-HPT).
The test measures the time required to place and remove nine pegs using the affected hand.
Shorter completion times indicate better manual dexterity.
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Baseline and after the 8-week intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Manual Ability in Daily Activities
기간: Baseline and after the 8-week intervention
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Manual ability in daily activities will be assessed using the ABILHAND-Kids questionnaire.
The questionnaire evaluates the child's perceived difficulty in performing everyday bimanual activities.
Higher scores indicate better manual ability.
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Baseline and after the 8-week intervention
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Change in Hand Grip Strength
기간: Baseline and after the 8-week intervention
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Hand grip strength of the affected hand will be assessed using a Jamar hand dynamometer.
Grip strength will be recorded in kilograms.
Higher values indicate greater hand grip strength.
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Baseline and after the 8-week intervention
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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
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