Using Blood Flow Restriction to Improve Upper Limb Rehabilitation in Multiple Sclerosis

Effects of a Low-intensity Muscle Strengthening Protocol in Combination With Blood Flow Restriction Training on Upper Limb Impairment in People With Multiple Sclerosis. A Randomized Controlled Trial

This study is testing if a new way of training that restricts blood flow can help people with Multiple Sclerosis improve their arm strength and overall quality of life better than regular physical therapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universidad Rey Juan Carlos (other)
• Locations: 1 site (Leganés, Madrid)
• Trial ID: NCT06795230 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Blood Flow Restriction Training (BFRT) combined with low-intensity muscle strengthening on upper limb strength, fatigability, dexterity, functionality, and quality of life in individuals with Multiple Sclerosis (MS). Participants will be randomly assigned to receive either BFRT or conventional physical therapy. The study aims to determine if BFRT is more effective than traditional methods in enhancing rehabilitation outcomes for MS patients. Additionally, the trial will assess participant adherence and satisfaction with the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a confirmed diagnosis of Multiple Sclerosis and specific disability criteria.

Not a fit: Patients with severe upper extremity muscle tone or those unable to participate in physical activity may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes and quality of life for patients with Multiple Sclerosis.

How similar studies have performed: While research on BFRT in neurological conditions is limited, preliminary studies suggest potential benefits, indicating this approach may be novel and underexplored.

Eligibility criteria

Inclusion Criteria:

* \>18 years of age.
* Diagnosis of MS according to McDonald criteria (53) with a time of evolution longer than two years.
* Assessment on the Kurtzke Multiple Sclerosis Disability Status Scale (EDSS) with a score between 2. 0 (minimal disability in one section of the FS (at least one with a score of 2).) to 7.0 (unable to walk more than a few steps, even with assistance, basically confined to wheelchair and able to transfer from wheelchair to another place, or can manage to go to the toilet for 12 hours a day) .
* Stable medical treatment for at least six months prior to surgery.
* Upper extremity muscle tone no greater than 2 points (moderate hypertonia, increased muscle tone during most of the arc of motion, but can passively move the affected part with ease) on the modified Ashworth Scale.
* Muscle balance equal to or greater than 3 in the upper extremity.
* Score less than or equal to 4 points on the "Pyramidal Function" section of the EDSS functional scale.
* Absence of cognitive impairment, with ability to understand instructions and score equal to or greater than 24 on the Minimental Test.
* A score equal to or less than 2 points on the "Mental Functions" section of the EDSS.

Exclusion Criteria:

* Diagnosis of a neurological disease or musculoskeletal disorder other than MS.
* Diagnosis of a cardiovascular, respiratory or metabolic disease or other conditions that may interfere with this study.
* Having suffered an exacerbation or hospitalization in the last 3 months before starting the assessment protocol, or during the therapeutic intervention process.
* Having received a course of steroids, intravenous or oral, 6 months prior to the start of the assessment protocol and within the intervention period of the study duration.
* Having received treatment with botulinum toxin in the 6 months prior to the start of the study.
* A score higher than 2 points on the modified Ashworth scale.
* Cognitive or language impairment that prevents adequate communication or comprehension.
* Medical complications such as: history of deep vein thrombosis, pulmonary embolism, vascular disease, thrombophilia, or any circulatory or coagulation disorder.

Where this trial is running

Leganés, Madrid

• Asociación de Leganés de Esclerosis Múltiple — Leganés, Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Roberto Cano de la Cuerda, PT, PhD — Universidad Rey Juan Carlos
• Study coordinator: Roberto Cano de la Cuerda, PT, PhD

Conditions: Multiple Sclerosis, Multiple sclerosis, Upper limb, Rehabilitation, Blood Flow Restriction Training