The Effect of Blood Flow Restriction Training on Gait Performance on Forty Chronic Stroke Patients Evaluated by STEADYs Gait Assessment. (BFRT)

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke Gait Rehabilitation
• Intervention / Treatment: Other: Blood flow restriction training; Other: Resistance Exercises for lower limb affected

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • الجيزة
    • Giza, الجيزة, Egypt, 12511
      • Outpatient Clinics of faculty of physical therapy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood flow restriction training; Blood flow restriction training with resistance Exercises for the lower limb affected	Other: Blood flow restriction training; Using BFRT combined with Resistance Exercises; Other Names: KAATSU Training; Other: Resistance Exercises for lower limb affected; Resistance Exercises using weights applied from different positions
Other: Resistance Exercises; Resistance Exercises for Lower limb affected.	Other: Resistance Exercises for lower limb affected; Resistance Exercises using weights applied from different positions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Each patient will be assigned to do every item of the DGI in 10 minutes Pre and post study

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Anas A Mohsen, B.Sc, Egyptian Ministry of Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 2, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: BFRT,Stroke,Gait performance.
• Additional Relevant MeSH Terms: Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: P.T.REC/012/006174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes