Blood Flow Restriction for Upper Limb Rehabilitation in People With Multiple Sclerosis. A Randomized Controlled Trial (BFRT-EM)

NCT06795230 | Recruiting

• 1 other identifier: UniversidadRJC1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Although the Blood Flow Restriction Training (BFRT) system has attracted the attention of health professionals, research on this tool in people with neurological pathology, particularly multiple sclerosis (MS), is very limited. Furthermore, to our knowledge, studies on the effect of the BFRT system on forearm-hand muscle strength and fatigability, coordination and dexterity, functionality and quality of life in people with MS are nonexistent. The main objective of our study are:

• To know the effects of low intensity training in combination with the BFRT system on upper limb strength and forearm and hand fatigability, dexterity, functionality and quality of life in people with MS. Secondary Objectives
• To know if a low-intensity muscle strengthening program in combination with the BFRT system is superior to a conventional strengthening program.
• To know the adherence and satisfaction with the experimental intervention. The investigators propose to conduct a randomized controlled trial (RCT) with examiner blinding with pre-intervention, post-intervention and follow-up assessment, following the recommendations of the CONSORT guidelines, designed to study the effects of the application of a low-intensity muscle strengthening program in combination with the BFRT system. This intervention will be carried out at the Leganés Multiple Sclerosis Association (ALEM). Patients will be randomly assigned through the GraphPad Software® QuickCalcs application to 2 study groups. A control group, which will receive a low intensity strengthening program in combination with the BFRT system; and an experimental group, which will receive a high intensity strengthening program. Voluntary participation will be requested from patients diagnosed with MS in the Leganés Multiple Sclerosis Association (ALEM) who meet the inclusion criteria. Acceptance of the study and signature of the informed consent form will be required prior to the start of the program. As this is the first study to evaluate the effectiveness and feasibility of a low-intensity muscle strengthening protocol in combination with BFRT on forearm and hand muscle strength and fatigability, coordination, dexterity, functionality and quality of life in people with MS, the sample size will be determined based on the most similar scientific literature possible. Hill et al developed an investigation comparing the adaptations of MS patients to two types of intervention: high intensity or conventional strengthening program versus low intensity in combination with BFRT. Since this is the only investigation to date that includes MMSS exercises in their intervention, we consider that the sample size proposed by Hill et al is the most appropriate for our investigation. The sample size obtained in that investigation was 19 subjects, so for the sample size of the present investigation a total of 19 subjects is proposed. However, estimating a 10% possible percentage of losses, we estimate a total of 21 total participants to be recruited. Patients will be randomly assigned via the GraphPad Software® QuickCalcs application to 2 study groups. A control group, which will receive a low-intensity strengthening program in combination with the BFRT system; and an experimental group, which will receive a high-intensity strengthening program.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Upper limb; Rehabilitation; Blood Flow Restriction Training

Outcome Measures

Primary Outcomes (1)

• Isometric prehensile hand strength (Kg)

  Isometric prehensile hand strength: measured by the JAMAR® fist dynamometer. The JAMAR® dynamometer has been widely cited and is considered the gold standard for the assessment of fist strength. Three measurements of the maximum voluntary maximum isometric contraction (MVC) will be taken with each hand, always starting with the least affected hand; once the three measurements have been taken, the mean of these will be obtained. Major values (Kg) means a higher hand grip strengh (there is not a maximum).

  Up to 8 weeks

Secondary Outcomes (6)

• Isometric pincer force (Kg)

  Up to 8 weeks

• Gross coordination for the upper limb (Block and Box; number of cubes)

  Up to 8 weeks

• Fine coordination for the upper limb (NHPT; time in seconds)

  Up to 8 weeks

• Functional status of the upper limb (ABILHAND)

  Up to 8 weeks

• Quality of life (MSIS-29)

  Up to 8 weeks

Study Arms (2)

Conventional muscle strengthening

ACTIVE COMPARATOR

Palmar flexion and dorsal flexion; ulnar deviation and radial deviation; pronation and supination; elbow flexion and extension, with a dumbbell at 70% of the 1RM, performing a total of 4 series of 8 - 12 repetitions each, avoiding reaching muscle failure in each series.

Other: Conventional physical therapy

BFRT

EXPERIMENTAL

The experimental group will carry out a low-intensity strengthening program (20% 1RM) in combination with the BFRT system composed of the following exercises: palmar flexion and dorsal flexion; ulnar deviation and radial deviation; pronation and supination; elbow flexion and extension, performing 4 series of 30/15/15/15 repetitions as usual in this type of interventions.

Other: Muscle strengthening (BFRT)

Interventions

Muscle strengthening (BFRT) OTHER

The experimental group will perform a low-intensity strengthening program (20% 1RM) in combination with the BFRT system consisting of the following exercises: palmar flexion and dorsal flexion; ulnar deviation and radial deviation; pronation and supination; elbow flexion and extension, performing 4 sets of 30/15/15/15 repetitions as usual in this type of interventions. Once the first exercise has been completed, a rest of 3 - 4 minutes should be taken depending on the fatigue perceived by the patient. Subsequently, the other two exercises will be performed following the scheme already outlined. Taking into account the scientific evidence concerning the safety and adverse effects linked to the BFRT system, it is determined that the pressure applied in the experimental protocol will be 60% of the TRP of each subject, following the recommendations that locate the effective pressure between 50 - 80% of the TRP of each subject.

BFRT

Conventional physical therapy OTHER

The control group will perform a conventional muscle strengthening protocol consisting of the following exercises: palmar flexion and dorsal flexion; ulnar deviation and radial deviation; pronation and supination; elbow flexion and extension, with a dumbbell at 70% of 1RM, performing a total of 4 sets of 8 - 12 repetitions each, avoiding muscle failure in each set.

Conventional muscle strengthening

Eligibility Criteria

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

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Asociación de Leganés de Esclerosis Múltiple

Leganés, Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Roberto Cano de la Cuerda, PT, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Cano de la Cuerda, PT, PhD

CONTACT

+34914888674; roberto.cano@urjc.es

Aitor Blázquez Fernández, PT

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD. Full Professor

Model Details: Rehabilitation treatment. We do not use drugs or vaccines.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)