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

Study acronym: BFRT-EM
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Jan 31, 2026 to Dec 31, 2026
    • Study site revised
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  3. Minor Study description shortened, about 7 words
    • Study title expanded, about 1 word
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06795230
Lead Sponsor Universidad Rey Juan Carlos
Conditions
(from sponsor)
Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov