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

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia
• Intervention / Treatment: Other: the selected physical therapy program; Other: Blood Flow Restriction training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: 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.
Experimental: 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	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of muscle architecture	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of muscle strength	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	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	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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 20, 2025

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemiplegia; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: Ibrahim-Msc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No