- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07648550
Effect of Blood Flow Restriction Training on Quadriceps Muscle Architecture and Functional Abilities in Children With Hemiplegia
2026년 6월 10일 업데이트: Eman Kamal Abdelmoteleb, Cairo University
This study was done to investigate the effect of blood flow restriction in the lower limbs on:
Strength of the quadriceps muscle, quadriceps muscle architecture (muscle thickness and pennation angle between muscle fibres), selective motor control of the lower limb in the affected limb, and gait parameters.
연구 개요
상세 설명
Current clinical practice for managing children with cerebral palsy employs various treatments rather than a single approach.
Blood flow restriction training, using pneumatic tourniquets to restrict blood flow to limbs, results in hypoxia and increased intramuscular pressure during contractions.
Although research on blood flow restriction has expanded, many practitioners lack clarity on its application and safety.
Evidence indicates that Blood flow restriction resistance exercise enhances muscle strength and hypertrophy more effectively than low-load resistance exercise alone.
This study suggests a multimodal treatment combining Blood flow restriction and strength training could expedite rehabilitation, particularly for children with hemiplegia.
연구 유형
중재적
등록 (실제)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Al Mansurah, 이집트
- outpatient clinics of General Hospitals in Dakahlia governorate.
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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:
- Hemiplegic cerebral palsied children.
- The children age will be ranges from 3-8 years chronologically.
- The children will have degree of spasticity ranged from 1 to 2 on Modified Ashworth Scale
- The children will have Level I according to the Gross Motor Function Classification System.
- All children will be able to follow instructions.
Exclusion Criteria:
children were excluded from the study if they have any problems of the following:
- Cognitive dysfunction.
- Recent nonunion fracture.
- Fixed contractures and deformities.
- Previous surgery and Impaired circulation of that lower limb.
- Received Botulinum toxin A injections in the last six months.
- Children suffers from Peripheral Arterial and venous Diseases in the hemiplegic limb.
- Children suffering from uncontrolled convulsions.
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 |
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활성 비교기: selected physical therapy program
Children in the control group will receive the selected physical therapy (PT) program one hour three times weekly for eight successive weeks
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The physical therapy program includes passive stretching exercises for the lower limb to enhance range of motion (ROM) in children with cerebral palsy (CP), transition training from sitting to standing to improve postural control, and core stability exercises to boost trunk endurance and gait.
Reactive balance training aims to improve children's postural response organization, while various walking training methods, including treadmill and obstacle walking, focus on enhancing gait speed, balance, and postural stability.
Overall, the program is designed to address specific impairments and activity limitations in children with hemiplegic CP.
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실험적: selected physical therapy program and Blood Flow Restriction
This group will receive the selected physical therapy program as group (A) in addition to blood flow restriction on the upper thigh.
Training Frequency will be one hour for 2-3 times a week for 8 weeks
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The physical therapy program includes passive stretching exercises for the lower limb to enhance range of motion (ROM) in children with cerebral palsy (CP), transition training from sitting to standing to improve postural control, and core stability exercises to boost trunk endurance and gait.
Reactive balance training aims to improve children's postural response organization, while various walking training methods, including treadmill and obstacle walking, focus on enhancing gait speed, balance, and postural stability.
Overall, the program is designed to address specific impairments and activity limitations in children with hemiplegic CP.
This group will undergo a physical therapy program incorporating Blood Flow Restriction therapy on the upper thigh.
The training will consist of one hour sessions, 2-3 times a week for 8 weeks.
The load applied will be 20-40% of One-repetition maximum (1RM), with 5-10 minutes of restriction time per exercise set.
Each session will include 4 sets, totaling 75 repetitions (30 × 15 × 15 × 15), along with reperfusion between sets.
Pressure application will be 40-80% of arterial occlusion pressure (AOP), with rest periods of 30-60 seconds between sets.
The restriction form will be continuous, with an execution speed of 1-2 seconds for each exercise, continuing until the planned repetitions are completed.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assessment of muscle architecture
기간: at baseline and after 8 weeks
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One method to evaluate muscle function and morphology is through skeletal muscle architecture analysis, which examines the geometric arrangement of muscle fibers using non-invasive ultrasound techniques.
Key parameters include muscle thickness, which correlates with strength, and pennation angle, which affects force transmission to tendons.
Measurements are conducted with participants supine, allowing stabilization, and involve high-quality ultrasound imaging (B-mode) for consistent results.
An experienced researcher measures muscle thickness and pennation angle using standardized protocols and software for analysis, ensuring accuracy across assessments.
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at baseline and after 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assessment of muscle strength
기간: at baseline and after 8 weeks
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The isometric strength of knee extensor muscles will be measured using a handheld dynamometer, with a standardized position.
A 'make' test will require participants to exert maximum effort against a constant resistance for 3 to 5 seconds.
Children will be positioned with the dynamometer on the anterior tibia, while seated with knees and hips flexed at 90 degrees.
Each child will have two practice trials before performing three trials, receiving strong encouragement to maximize force output, which will be recorded.
If a participant cannot effectively isolate the muscle group or generate sufficient force, a zero score will be noted.
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at baseline and after 8 weeks
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Assessment of selective motor control
기간: at baseline and after 8 weeks
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The Scale evaluates five reciprocal lower extremity movements: hip flexion-extension, knee flexion-extension, ankle dorsiflexion-plantar flexion, subtalar inversion-eversion, and toe flexion/extension.
The hip test is performed in a side-lying position, while the others are conducted in a seated position.
Each movement is passively executed by the tester using a three-second verbal cadence.
Each limb is assessed separately, focusing on selective joint movement and avoiding extraneous motions.
Movements are scored on a scale of 0-2: 2 (Normal) for complete movements within the cadence, 1 (Impaired) for partial isolated movements or deviations, and 0 (Unable) for lack of movement initiation.
The total score per limb can reach a maximum of 10.
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at baseline and after 8 weeks
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Assessment of gait
기간: at baseline and after 8 weeks
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The observational gait scale will be used to analyze typical walk viewed on split-screen video in slow motion.
The children will be instructed to walk, and videos will be taken from the side.
Children will be videotaped, six sections will be tested to evaluate knee and ankle kinematics (Knee position in mid stance, Initial foot contact, Foot contact at mid stance, Base of support, Gait assistive devices, degree of change) with a total score of 22 on each limb.
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at baseline and after 8 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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 (실제)
2025년 10월 5일
기본 완료 (실제)
2025년 12월 1일
연구 완료 (실제)
2025년 12월 20일
연구 등록 날짜
최초 제출
2026년 6월 10일
QC 기준을 충족하는 최초 제출
2026년 6월 10일
처음 게시됨 (실제)
2026년 6월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 10일
마지막으로 확인됨
2026년 6월 1일
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. .
the selected physical therapy program에 대한 임상 시험
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Foundation University Islamabad모병