NCT07575620

Brief 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?

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Apr 2026Nov 2026

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 2, 2026

Last Update Submit

May 7, 2026

Conditions

Keywords

BFRT,Stroke,Gait performance.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The changes of scoring of dynamic gait index

    Each patient will be assigned to do every item of the DGI in 10 minutes Pre and post study

Study Arms (2)

Blood flow restriction training

EXPERIMENTAL

Blood flow restriction training with resistance Exercises for the lower limb affected

Other: Blood flow restriction trainingOther: Resistance Exercises for lower limb affected

Resistance Exercises

OTHER

Resistance Exercises for Lower limb affected.

Other: Resistance Exercises for lower limb affected

Interventions

Using BFRT combined with Resistance Exercises

Also known as: KAATSU Training
Blood flow restriction training

Resistance Exercises using weights applied from different positions

Blood flow restriction trainingResistance Exercises

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinics of faculty of physical therapy Cairo University

Giza, الجيزة, 12511, Egypt

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Anas A Mohsen, B.Sc

    Egyptian Ministry of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 8, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations