- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06859905
Blood Flow Restriction Training on Upper Limb Performance
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ha'il Region
-
Ha'il, Ha'il Region, Saudi Arabia, 2442
- Hail-Waseta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
this group will receive blood flow restriction training (BFRT) plus regular exercises for the upper extremity for 8 weeks
|
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
the routine rehabilitation will be applied 3 times per week for 8 weeks, including the following training
|
|
Active Comparator: control group
this group will receive regular exercises for 8 weeks
|
the routine rehabilitation will be applied 3 times per week for 8 weeks, including the following training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle power
Time Frame: at base line and after 8 weeks of tretment
|
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
Time Frame: at base line and after 8 weeks of tretment
|
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.
|
at base line and after 8 weeks of tretment
|
|
The Stroke Upper-Limb Capacity Scale
Time Frame: at base line and after 8 weeks of tretment
|
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
Time Frame: at base line and after 8 weeks of tretment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Disability Arm Shoulder Hand
Time Frame: at base line and after 8 weeks of tretment
|
Modified Disability Arm Shoulder Hand (QuickDASH), is a validated and widely used 11-item questionnaire that measures upper-extremity specific symptoms and disability
|
at base line and after 8 weeks of tretment
|
|
Patient satisfaction (PSQ 18)
Time Frame: at base line and after 8 weeks of tretment
|
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
|
at base line and after 8 weeks of tretment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2025-618
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Hemiparesis
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Not yet recruitingPost-stroke HemiparesisUnited States
-
University of MinnesotaCompleted
-
Pamukkale UniversityCompletedSatisfaction, Patient | Hemiparesis;Poststroke/CVATurkey
-
UGECAM Rhône-AlpesRecruitingHemiparesis;Poststroke/CVAFrance
-
Reuth Rehabilitation HospitalUniversity of HaifaRecruitingHemiparesis;Poststroke/CVAIsrael
-
Loma Linda UniversityCompletedHemiparesis;Poststroke/CVAUnited States
-
Taipei Medical University WanFang HospitalWithdrawnPoststroke/CVA HemiparesisTaiwan
-
NYU Langone HealthCompleted
-
University of MinnesotaCompletedCongenital HemiparesisUnited States
-
Kutahya Health Sciences UniversityNot yet recruitingHemiplegia and/or Hemiparesis Following StrokeTurkey (Türkiye)
Clinical Trials on blood flow restriction training
-
Rush University Medical CenterWithdrawnAnterior Cruciate Ligament Injuries | Physical Therapy | ACL
-
University of West AtticaNot yet recruiting
-
Caitlin ConleyThe Cleveland ClinicRecruitingWounds and Injuries | Knee Injuries | Patellar Dislocation | Leg InjuryUnited States
-
Womack Army Medical CenterThe Geneva Foundation; Telemedicine & Advanced Technology Research CenterTerminatedAchilles TendinopathyUnited States
-
Riphah International UniversityRecruitingBlood Flow RestrictionPakistan
-
Ibadat International University, IslamabadNot yet recruiting
-
Lauren EricksonAmerican College of Sports MedicineCompleted
-
University GhentRecruitingHamstring InjuryBelgium
-
University of AarhusAarhus University Hospital; Aalborg University Hospital; Gødstrup Hospital; Regionshospitalet...RecruitingAchilles Tendon RuptureDenmark
-
Riphah International UniversityCompletedSports Physical TherapyPakistan