Blood Flow Restriction Training on Upper Limb Performance

NCT06859905 | Completed

• 1 other identifier: H-2025-618
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Background; Blood flow restriction training (BFRT) is a physical intervention that promotes many beneficial muscular activities and functions when low load/intensity is used in healthy and clinical populations. Objectives: To determine the effect of BFRT on upper extremity motor function, strength, and Activity of daily living in chronic/acute stroke patients.

Conditions

Hemiparesis

Keywords

cerebro vascular accident, hemoplegia, blood restriction, performance, upper extremity

Outcome Measures

Primary Outcomes (4)

• Muscle power

  muscle power will be assessed using by Manual muscle test for shoulder and elbow flexor and extensor

  at base line and after 8 weeks of tretment

• 2- Hand grip strength

  handgrip strength will be measured using (hand dynamometer ) Based on previous studies, the JAMAR® Hydraulic Hand Dynamometer has been widely used, and has been validated and reliable. 1. The subject should sit with the back, pelvis, and knees as close to 90 degrees as possible. 2. The shoulder is adducted and neutrally rotated, elbow at 90 degrees flexion, forearm neutral, wrist held between 0-15 degrees of ulnar deviation. 3. A dynamometer is placed vertically on the forearm without support from the examiner or armrest. 4. Three trials are taken to determine the maximum grip.

  at base line and after 8 weeks of tretment

• The Stroke Upper-Limb Capacity Scale

  The Stroke Upper-Limb Capacity Scale (SULCS) is a validated tool for upper extremity (UE) functional tasks, SULCS measures upper limb capacity, including basic arm capacities. There are ten items in the SULCS that represent meaningful tasks that relate to daily activities at home. The selection of these tasks was based on extensive interviews with rehabilitation physicians, occupational therapists, and physical therapists

  at base line and after 8 weeks of tretment

• Activity of daily living by Barthel Index

  Activity of daily living by Barthel Index Functional independence was assessed using the Barthel Index, validated for cerebrovascular diseases and elderly , The index analyzes 10 aspects: bowels, bladder, grooming, toilet use, feeding, transfer, mobility, dressing, stairs, and bathing. The total score ranges from 0 to 100 points. The higher the score, the greater the functional independence

  at base line and after 8 weeks of tretment

Secondary Outcomes (2)

• Modified Disability Arm Shoulder Hand

  at base line and after 8 weeks of tretment

• Patient satisfaction (PSQ 18)

  at base line and after 8 weeks of tretment

Study Arms (2)

study group

EXPERIMENTAL

this group will receive blood flow restriction training (BFRT) plus regular exercises for the upper extremity for 8 weeks

Other: blood flow restriction training; Other: regular exercises

control group

ACTIVE COMPARATOR

this group will receive regular exercises for 8 weeks

Other: regular exercises

Interventions

blood flow restriction training OTHER

Position of the patient The vascular occlusion pressure required for the full blockage of upper extremity blood flow will be measured at rest, with the individual relaxed in a sitting position(Sieljacks et al., 2018). Position of the of the cuff during BFRT Placing a 5 to 6 cm wide cuff on the more proximal part of the affected upper limb, it should be around the bulk of biceps muscle above the cubital fossa . BFRT Cuff Pressure The upper arm external pressure of the cuff (100-130 mmHg) will be selected concerning the subject's resting blood pressure as described previously by Yasuda et al. 2008 (Yasuda et al., 2008). BFRT exercises prescription 1. Exercise frequency and duration -The study group (BFRT G) will be subjected to supervised exercises with low-load blood flow restriction training LIBFR (three days per week for 8 weeks), 2. Exercise intensity -Low load blood flow restriction training LIBFR (20%-40% of 10 repetition maximum (10 RM) BFR training for the study group,

study group

regular exercises OTHER

the routine rehabilitation will be applied 3 times per week for 8 weeks, including the following training 1. Appropriate neurodevelopmental techniques as needed by each patient 2. Progressive resistance exercise for muscles in the affected upper extremity using sandbags, free weights, or elastic resistance bands according to each patient's abilities 3. prolonged stretching using splints if needed 4. Functional electrical stimulation (FES)

control group; study group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ years of age.
• The diagnosis of stroke
• Confirmed by cranial CT and/or MRI
• Hemipaises (weakness of one side of the body ), clear consciousness, stable vital signs

You may not qualify if:

• Uncontrolled hypertension
• Coronary artery disease
• Deep vein thrombosis
• Severe osteoarthritis
• Cognitive impairment, inability to cooperate
• Any severe musculoskeletal problem that prevented the participants from doing resistance training
• unstable complications related to heart, lung, and kidney diseases.
• Serious cognitive or audio-visual impairment
• Mini-Mental Scale Examination score, \<24)

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

Hail-Waseta

Ha'il, Ha'il Region, 2442, Saudi Arabia

Location

MeSH Terms

Conditions

Paresis

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the participants will be allocated using the closed-envelop method with each envelop containing a card with a coded number. Particiants will be treated using these code numbers throughout the study. only the outcome assessor will not be allowed to have the interpritation of the coded numbers till the end of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The participants will be randomly divided into two groups: The study group low-load blood flow restriction training LIBFR(BFRT G), and control group (C G), all subjects in the control and BFRTG will receive the routine rehabilitation 3 times per week for 8 weeks

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: May 30, 2025
• Primary Completion: April 25, 2026
• Study Completion: April 28, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)