Blood Flow Restriction Training in Multiple Sclerosis

(Effect of Blood Flow Restriction Training on Muscle Strength and Gait Performance in Multiple Sclerosis Patients).

Traditional physical therapy resisted training for people with MS have been shown to be beneficial; however, their usefulness has been limited by fatigue. The effect of blood flow restriction on strength and other measures of physical function was demonstrated in healthy populations and those with chronic disease. This study may add missing information to the existing literature and suggests directions for research on the effectiveness of BFR training on individuals with relapsing and remitting MS.

Study Overview

• Status: Recruiting
• Conditions: MS
• Intervention / Treatment: Other: strengthening ex; Other: strengthening ex with BFR training

Detailed Description

Multiple sclerosis patients are characterized by impaired functional capacity which is related to reduce muscle strength affecting predominantly the lower extremity.

Resistance training (RT) has proven to be one of the interventions in MS patients showing a consistent and positive effect on muscle strength and on parameters directly related to lower extremity physical function (eg, walking performance and stair negotiation).

Training with blood flow restriction (BFR), is an increasingly common clinical intervention among physical therapists over the past decade and consistent with the evidence. It has been investigated in people with neurological disorders including stroke and incomplete Spinal Cord Injuries. Research is limited on the use of BFR for individuals with MS.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Habiba Zienhom; Phone Number: 002 01061209505; Email: Habiba_future@yahoo.com

Study Locations

• Egypt
  • Giza, Egypt, +20
    • Recruiting
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients were diagnosed with MS by a neurologist according to McDonald's criteria 2010
2. Expanded Disability Status Scale (EDSS) scores ranging from 2.5 to 5.5 .
3. Patient able to walk 100 meters or more.
4. No change within MS specific medication three months from the study.
5. Last Ms Attack from more than two months.

Exclusion Criteria:

1. Multiple sclerosis patients with other neurological or orthopedic problems.
2. Multiple sclerosis patients with systemic problems (cardiovascular or pulmonary diseases…).
3. Patients with cognitive impairment.
4. Pregnant female patients.

5. Patients in acute relapse stage.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The control group (A) will receive therapeutic strengthening training program for lower extremities.; low intensity strengthening exercise program	Other: strengthening ex; Therapeutic strengthening training program for lower extremities.
Active Comparator: The study group (B) will receive strengthening training with blood flow restriction; the same selected low intensity resisted exercise program as group (A) with blood flow restriction	Other: strengthening ex with BFR training; Therapeutic strengthening training with blood flow restriction of trained limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strength	measure maximal torque production at a specified velocity of limb movement. measure torque of hip flexors , extensors , knee flexors and extensors	one week after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gait performance by Two-dimensional (2D) Motion Analysis system	kinematic analysis of gait (step length , stride length)	one week after the end of treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Habiba Zienhom, Cairo university; Study Director: Dr.Moshera Hassan Darwish, professor, professor of physical therapy,aculty of Physical therapy ,Cairo university; Study Director: Dr Mohamed Soliman Al-Tamawy, professor, professor of Neurology, Faculty of Medicine,Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: BFR in MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No