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HemiparesisNCT06859905

Blood Flow Restriction Training on Upper Limb Performance

A study testing blood flow restriction training and regular exercises in people with Hemiparesis, run by University of Hail at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Hemiparesis
What is being tested?
blood flow restriction training and regular exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSaudi Arabia
Study dates
30 May 2025to 28 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 30 ≥ 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

Who cannot join

  • 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
Show all 9Show fewer
  • unstable complications related to heart, lung, and kidney diseases.
  • Serious cognitive or audio-visual impairment
  • Mini-Mental Scale Examination score, <24)

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Hail-Waseta

    Ha'il, Ha'il Region, 2442

Other trials in Saudi Arabia

About this study

Official title: The Effectiveness of Blood Flow Restriction Training on Upper Limb Motor Function, Strength, and Activity of Daily Living in Hemiparesis Post-stroke Patients

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.

Read the detailed description

A cerebrovascular accident (CVA) is often known as a stroke and can be described as a localized neurological deficiency caused by various cardiovascular abnormalities that disrupt brain function. Stroke is the primary cause of death worldwide, it also leads to a substantial number of disability among the population.

There is no doubt that stroke is one of the most common causes of adult-onset disabilities. 70-85% of the first strokes are associated with hemiplegia which is usually followed by hemiparesis. Only 60% of patients suffering from hemiparesis need physical rehabilitation and have attained functional independence in basic activities of daily living (ADLs) such as using the restroom and short-distance walking. Patients with sensorimotor and visual-field loss are much more dependent on care than those with pure motor impairments.

Stroke patients require post-stroke rehabilitation and physical therapy procedures to improve their recovery and quality of life. A multidisciplinary approach that addresses each patient's unique physical, occupational, and speech deficits can assist optimize their functional abilities and encourage independence.

Hemiplegic stroke rehabilitation involves structured, interdisciplinary, supportive services that start 48 hours after the stroke starts for stable patients. Although patients and families generally benefit from inpatient and outpatient rehabilitation, each treatment modality's efficacy falls short of standards set by evidence-based therapy (reference). Rehabilitation has always been around teaching patients how to compensate with their unaffected arm or limb. The major goals of physical, occupational, and speech therapists are to modify the surroundings and develop new skills in order to keep patients at home with the least amount of care assistance. The removal of architectural impediments to movement, problem-solving techniques, supporting social and psychological services, braces and other orthotics, and equipment like wheelchairs and walkers all continue to be crucial in assisting patients in doing daily life tasks (Dobkin, 2004).

The goal of physical therapy rehabilitation modalities post-stroke is to enhance activities of daily living, enhance range of motion, reduce pain, and improving muscle tone. Previous studies on BFRT have focused on healthy populations, limited number of observational trials have been performed on BFRT in patients with neurological problems, such as Parkinson's disease, multiple sclerosis, spinal cord injury, and stroke.

BFRT involves partially restricting arterial blood flow into muscles as well as occluding the venous outflow during exercise. It was first introduced into the literature by a Japanese doctor Yoshiaki Sato in Japan in 1987 who used tourniquet ischemia to induce muscle fatigue. This technique was originally called "kaatsu training," meaning "training with added pressure." Kaatsu training is now performed all over the world and is more commonly referred to as "BFRT" and is achieved using a pneumatic tourniquet system.

In addition to physical rehabilitation, BFRT is used for physical training and performance in healthy individuals. There has been extensive research into its value as a training tool, including elite- and amateur-level athletes, untrained young and older adults, and hypertensive individuals.

In addition to reducing arterial blood flow to working muscles, blood flow restriction obstructs venous return. When active muscles are exposed to BFR conditions, they are subjected to ischemia, which increases the metabolic stress on them. In addition to BFR, venous occlusion increases muscle cell swelling, activates intracellular anabolic pathways, and recruits fast-twitch fibers, which are thought to be involved in muscle adaptation.

There were different Factors affecting exercise adaptations with BFR including pressure of occlusion (partial or complete), type of occlusion (continuous or intermittent), intensity of exercise, and volume of exercise with BFR.

BFR along with low-load resistance training, cardio endurance training, and other activities that are generally recommended to improve muscular mass/strength are also associated with these adaptations in muscles.

The combination of Low-load Resistance Exercise with Body-Focused Rehabilitation (BFR) promotes greater strength adaptations and hypertrophy than the combination of Low-Load Resistance Exercise with BFR alone. Exercises that combine low load resistance with BFR can promote comparable levels of hypertrophy to those that combine high load resistance.

The review done by Vinolo-Gil and colleagues revealed that treatment with blood flow restriction appears to be helpful for neurological conditions without having side effects. Improvements have been shown in gait, quality of life, endurance, muscle strength, and limb functions.

Many studies done on the effect of BFRT on the lower limb in stroke patients, for an example the randomized trial done to compare low-intensity resistance training with BFR (LIRT-BFR) and high-intensity resistance training in stroke patients, results revealed that BFRT produced a significant improvement in lower limb strength, balance, gait, and depression No previous studies done on the effect of BFRT on upper limbs in post-stroke patients so This study aims to study the effect of Blood Flow Restriction training on motor function, strength, and Activity of daily living in stroke patients.

Conditions
Hemiparesis
Being tested
blood flow restriction training, regular exercises
Keywords
cerebro vascular accident, hemoplegia, blood restriction, performance, upper extremity
Medical subject headings
Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood flow restriction trainingOther

    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,
  • regular exercisesOther

    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)
Study groups in NCT06859905
Study groupRoleWhat they receive
study groupExperimentalthis group will receive blood flow restriction training (BFRT) plus regular exercises for the upper extremity for 8 weeks
Receives: Other: blood flow restriction training; Other: regular exercises
control groupActive comparatorthis group will receive regular exercises for 8 weeks
Receives: Other: regular exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle power

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

    Measured: at base line and after 8 weeks of tretment

  2. 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.

    Measured: at base line and after 8 weeks of tretment

  3. 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

    Measured: at base line and after 8 weeks of tretment

  4. 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

    Measured: at base line and after 8 weeks of tretment

Secondary outcomes (2)
  1. Modified Disability Arm Shoulder Hand

    Modified Disability Arm Shoulder Hand (QuickDASH), is a validated and widely used 11-item questionnaire that measures upper-extremity specific symptoms and disability

    Measured: at base line and after 8 weeks of tretment

  2. Patient satisfaction (PSQ 18)

    Patient Satisfaction Questionnaire Short Form PSQ18 was validated for use among various settings to measure Patient Satisfaction regarding medical services, it was shortened from substantially larger questionnaires while maintaining internal consistency and reliability ,there are seven dimensions of patient satisfaction with their doctors including (interpersonal manner, communication, financial aspect, time spent with the doctor), The response options required the patients to rate each item using a 5-point rating scale. A scale of 1-5 is used to rank the answers, with 1 equaling totally disagreeing and 5 equaling totally agreeing. A higher score indicates a better relationship between the patient and the doctor or a higher level of patient satisfaction

    Measured: at base line and after 8 weeks of tretment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start30 May 2025
  3. Primary completion25 Apr 2026
  4. Study completion28 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06859905
Sponsor's protocol ID
H-2025-618
Status last verified
Apr 2026
First submitted
27 Feb 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: the data could be used in future study

Questions about this trial

What is this clinical trial studying?

A study testing blood flow restriction training and regular exercises in people with Hemiparesis, run by University of Hail at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle power (time frame: at base line and after 8 weeks of tretment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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