- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07292675
The Effect of Low Intensity With BFR on Stroke Patients
The Effect of Low Intensity Training With Blood Flow Restriction Versus Traditional Resistance Exercise on Lower Extermity Isokinetic Torque and Balance in Ischemic Stroke Patients
Study Overview
Status
Conditions
Detailed Description
Ischemic stroke commonly results in reduced lower extremity muscle torque and impaired balance, affecting mobility and fall risk.
Traditional resistance training improves muscle function but may not be suitable for all patients due to the need for high mechanical loads.
Low-intensity resistance training with blood flow restriction (BFR) has emerged as an alternative that enhances muscular adaptation at lower loads. However, limited data exists on its effect on isokinetic torque and functional balance in stroke patients. This study aims to fill this gap using objective isokinetic measurements and validated balance scales.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ibrahim A abu ella, Phd
- Phone Number: 0201008442281 +201008442281
- Email: ibrahimneuron@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• First-ever ischemic stroke (3-12 months post-stroke)
- Aged 30-40 years
- Can walk independently or with an aid
- Medically stable and able to follow instructions
Exclusion Criteria:
•Hemorrhagic stroke
- Deep vein thrombosis or peripheral vascular disease
- Orthopedic conditions affecting lower limb
- Severe cognitive impairment or uncontrolled hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
Study group will receive low-intensity BFR resistance training
|
"Low-Intensity" BFR Means (for Quads) It involves resistance 20-30% 1RM combined with partial arterial + full venous restriction using a cuff placed on the proximal thigh. |
|
Active Comparator: Control group
Control group will receive high intensity resistance training
|
High-intensity quadriceps training in stroke patients focuses on using 60-80% of 1RM to improve strength, motor unit recruitment, and functional mobility.
Exercises such as loaded sit-to-stand, leg press, and step-ups are commonly used to target the quadriceps safely.
Training intensity is guided by a perceived exertion of 7-9/10 while maintaining proper supervision to prevent falls.
This approach enhances knee stability, gait efficiency, and overall functional independence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Isokinetic torque
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005961
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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