Stroke Gait RehabilitationBFRTNCT07575620
The Effect of Blood Flow Restriction Training on Gait Performance on Forty Chronic Stroke Patients Evaluated by STEADYs Gait Assessment.
A study testing Blood flow restriction training and Resistance Exercises for lower limb affected in people with Stroke Gait Rehabilitation, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the effects of blood flow restriction on gait performance on stroke patients. The main question it aims to answer is: Is there a significant effect of blood flow restriction on gait performance on stroke patients? Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke Gait Rehabilitation
- What is being tested?
- Blood flow restriction training and Resistance Exercises for lower limb affected
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke patients more than 6 months.
- Ages of the patients will range from 40 to 65 years.
- The degree of spasticity ranged from 1 to 1+ grade (mild spasticity) according to the Modified Ashworth Scale.
- Ability to walk 10 m.
- Medically stable patients.
Who cannot join
- Patients with lower limb oedema.
- Patients with disability in visual, auditory, and vestibular systems.
- Resting systolic blood pressure>160 mmHg or resting diastolic blood pressure>100 mmHg.
- Cognitive deficits preventing them from undergoing the assessments, exercise program or informed consent process.
- Major neurological or musculoskeletal deficits from another diseases that could affect training.
- Patients with lower limb deep vein thrombosis.
- Patients who have any vascular problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinics of faculty of physical therapy Cairo University
Giza, الجيزة, 12511
About this study
Official title: Effect of Blood Flow Restriction on Gait Performance on Stroke Patients
The goal of this observational study is to learn about the effects of blood flow restriction on gait performance on stroke patients. The main question it aims to answer is:
Is there a significant effect of blood flow restriction on gait performance on stroke patients?
Read the detailed description
Blood flow restriction using pneumatic cuffs combined with low load resistance training has been demonstrated to increase muscle size and strength similar to that observed with traditional high load resistance training. This study may add missing information to the existing literature and suggests directions for research on the effectiveness of blood flow restriction training on gait performance in stroke patients.
- Conditions
- Stroke Gait Rehabilitation
- Being tested
- Blood flow restriction training, Resistance Exercises for lower limb affected
- Keywords
- BFRT,Stroke,Gait performance.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction trainingOther
Also called KAATSU Training
Using BFRT combined with Resistance Exercises
Resistance Exercises for lower limb affectedOther
Resistance Exercises using weights applied from different positions
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction training | Experimental | Blood flow restriction training with resistance Exercises for the lower limb affected Receives: Other: Blood flow restriction training; Other: Resistance Exercises for lower limb affected |
| Resistance Exercises | Other | Resistance Exercises for Lower limb affected. Receives: Other: Resistance Exercises for lower limb affected |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in gait performance
Using STEADYS gait assessment system all patients will be assigned to measure the gait phases and gait parameters pre and post study to assess if there is differences.
Measured: Pre study each patient will be included in the assessment as walking for 2 minutes wearing the IMU sensors and post study after 6 weeks
Secondary outcomes (1)
The changes of scoring of dynamic gait index
The DGI has 8 items each item with a scoring from 0 which means severe impairment in and 3 which means no gait dysfunction with a total score of 24. It is applied to evaluate gait deviations and risk of falling in people with neurological disorders.
Measured: Each patient will be assigned to do every item of the DGI in 10 minutes Pre and post study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Apr 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Gait RehabilitationStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Abdulaziz Abdulnabi Mohsen, Cairo University
- Investigators
- Anas A Mohsen, B.Sc, Principal investigator, Egyptian Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575620
- Sponsor's protocol ID
- P.T.REC/012/006174
- Acronym
- BFRT
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 8 May 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Flow Restriction on Gait Performance on Stroke Patients
- ClinicalTrials.gov ID
- NCT07575620
- Acronym / sponsor ID
- BFRT / P.T.REC/012/006174
- Conditions
- Stroke Gait Rehabilitation
- Keywords
- BFRT,Stroke,Gait performance.
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 May 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.
The goal of this observational study is to learn about the effects of blood flow restriction on gait performance on stroke patients. The main question it aims to answer is:
Is there a significant effect of blood flow restriction on gait performance on stroke patients?
Detailed description
Blood flow restriction using pneumatic cuffs combined with low load resistance training has been demonstrated to increase muscle size and strength similar to that observed with traditional high load resistance training. This study may add missing information to the existing literature and suggests directions for research on the effectiveness of blood flow restriction training on gait performance in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction training | Experimental | Other: Blood flow restriction training, Other: Resistance Exercises for lower limb affectedBlood flow restriction training with resistance Exercises for the lower limb affected |
| Resistance Exercises | Other | Other: Resistance Exercises for lower limb affectedResistance Exercises for Lower limb affected. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic stroke patients more than 6 months.
- Ages of the patients will range from 40 to 65 years.
- The degree of spasticity ranged from 1 to 1+ grade (mild spasticity) according to the Modified Ashworth Scale.
- Ability to walk 10 m.
- Medically stable patients.
Key exclusion criteria (7 listed)
- Patients with lower limb oedema.
- Patients with disability in visual, auditory, and vestibular systems.
- Resting systolic blood pressure>160 mmHg or resting diastolic blood pressure>100 mmHg.
- Cognitive deficits preventing them from undergoing the assessments, exercise program or informed consent process.
- Major neurological or musculoskeletal deficits from another diseases that could affect training.
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 |
|---|---|---|
| Blood flow restriction trainingAlso: KAATSU TrainingUsing BFRT combined with Resistance Exercises | Other | Blood flow restriction training |
| Resistance Exercises for lower limb affectedResistance Exercises using weights applied from different positions | Other | Blood flow restriction training, Resistance Exercises |
Primary outcome
The changes in gait performance
Time frame: Pre study each patient will be included in the assessment as walking for 2 minutes wearing the IMU sensors and post study after 6 weeks
Using STEADYS gait assessment system all patients will be assigned to measure the gait phases and gait parameters pre and post study to assess if there is differences.
1 secondary outcome
The changes of scoring of dynamic gait index
Time frame: Each patient will be assigned to do every item of the DGI in 10 minutes Pre and post study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Related trials for Stroke Gait Rehabilitation
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Active, not recruiting
Comparative Effects of Vestibular Rehabilitation With and Without Cervical JPS Training in Stroke Patients
Stroke
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
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.
Anas A Mohsen, B.Sc principal investigator
Egyptian Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction training and Resistance Exercises for lower limb affected in people with Stroke Gait Rehabilitation, 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 7 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: under way, not looking for participants, as of the sponsor's last update on 8 May 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?
This study is still under way. Results are not available in the source record yet.
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?
The changes in gait performance (time frame: Pre study each patient will be included in the assessment as walking for 2 minutes wearing the IMU sensors and post study after 6 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 8 May 2026.