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NCT Number: NCT07575620

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

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?

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Stroke Gait Rehabilitation

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinics of faculty of physical therapy Cairo University

Giza, الجيزة, 12511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Flow Restriction training

Other

Using BFRT combined with Resistance Exercises

Other names: KAATSU Training

Resistance Exercises for lower limb affected

Other

Resistance Exercises using weights applied from different positions

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Blood Flow Restriction on Gait Performance on Stroke Patients

Acronym: BFRT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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