Effect of Blood Flow Restriction Training on Quadriceps Muscle Architecture and Functional Abilities in Children With Hemiplegia
2026年6月10日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Al Mansurah、エジプト
- outpatient clinics of General Hospitals in Dakahlia governorate.
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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
|
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.
|
|
実験的：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
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of muscle architecture
時間枠：at baseline and after 8 weeks
|
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.
|
at baseline and after 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of muscle strength
時間枠：at baseline and after 8 weeks
|
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.
|
at baseline and after 8 weeks
|
|
Assessment of selective motor control
時間枠：at baseline and after 8 weeks
|
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.
|
at baseline and after 8 weeks
|
|
Assessment of gait
時間枠：at baseline and after 8 weeks
|
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.
|
at baseline and after 8 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年10月5日
一次修了 (実際)
2025年12月1日
研究の完了 (実際)
2025年12月20日
試験登録日
最初に提出
2026年6月10日
QC基準を満たした最初の提出物
2026年6月10日
最初の投稿 (実際)
2026年6月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月15日
QC基準を満たした最後の更新が送信されました
2026年6月10日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。