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Effect of Blood Flow Restriction Training on Quadriceps Muscle Architecture and Functional Abilities in Children With Hemiplegia

10 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Egypte
      • Al Mansurah, Egypte
        • outpatient clinics of General Hospitals in Dakahlia governorate.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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
Autre: the selected physical therapy program
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.
Expérimental: 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
Autre: the selected physical therapy program
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.
Autre: Blood Flow Restriction training
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Assessment of muscle architecture
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Assessment of muscle strength
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cairo University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 octobre 2025

Achèvement primaire (Réel)

1 décembre 2025

Achèvement de l'étude (Réel)

20 décembre 2025

Dates d'inscription aux études

Première soumission

10 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juin 2026

Première publication (Réel)

15 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Ibrahim-Msc

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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