HemiplegiaNCT07648550
Effect of Blood Flow Restriction Training on Quadriceps Muscle Architecture and Functional Abilities in Children With Hemiplegia
A study testing the selected physical therapy program and Blood Flow Restriction training in people with Hemiplegia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- the selected physical therapy program and Blood Flow Restriction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
outpatient clinics of General Hospitals in Dakahlia governorate.
Al Mansurah
About this study
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.
Read the 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.
- Conditions
- Hemiplegia
- Being tested
- the selected physical therapy program, Blood Flow Restriction training
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the selected physical therapy programOther
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.
Blood Flow Restriction trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: the selected physical therapy program; Other: Blood Flow Restriction training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and after 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start5 Oct 2025
- Primary completion1 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Kamal Abdelmoteleb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648550
- Sponsor's protocol ID
- Ibrahim-Msc
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Flow Restriction Training on Quadriceps Muscle Architecture and Functional Abilities in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT07648550
- Acronym / sponsor ID
- Ibrahim-Msc
- Conditions
- Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selected physical therapy program | Active comparator | Other: the selected physical therapy programChildren in the control group will receive the selected physical therapy (PT) program one hour three times weekly for eight successive weeks |
| selected physical therapy program and Blood Flow Restriction | Experimental | Other: the selected physical therapy program, Other: Blood Flow Restriction trainingThis 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 |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the selected physical therapy programThe 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 | selected physical therapy program, selected physical therapy program and Blood Flow Restriction |
| Blood Flow Restriction trainingThis 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. | Other | selected physical therapy program and Blood Flow Restriction |
Primary outcome
Assessment of muscle architecture
Time frame: 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.
3 secondary outcomes
Assessment of muscle strength
Time frame: at baseline and after 8 weeks
Assessment of selective motor control
Time frame: at baseline and after 8 weeks
Assessment of gait
Time frame: at baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the selected physical therapy program and Blood Flow Restriction training in people with Hemiplegia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of muscle architecture (time frame: at baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.