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

NCT07648550 | Completed

• 1 other identifier: Ibrahim-Msc
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of muscle strength

  at baseline and after 8 weeks

• Assessment of selective motor control

  at baseline and after 8 weeks

• Assessment of gait

  at baseline and after 8 weeks

Study Arms (2)

selected physical therapy program

ACTIVE COMPARATOR

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

selected physical therapy program and Blood Flow Restriction

EXPERIMENTAL

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; Other: Blood Flow Restriction training

Interventions

the selected physical therapy program OTHER

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.

selected physical therapy program; selected physical therapy program and Blood Flow Restriction

Blood Flow Restriction training OTHER

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.

selected physical therapy program and Blood Flow Restriction

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

outpatient clinics of General Hospitals in Dakahlia governorate.

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Hemiplegia

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start: October 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 20, 2025
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

EG (1)