Blood Flow Restriction Training in Multiple Sclerosis

MS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143930
• Other study ID #: BFR in MS
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: Habiba Zienhom
• Phone: 01061209505
• Email: Habiba_future[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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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Related Conditions & MeSH terms

• MS
• Multiple Sclerosis

Intervention

Other:
• strengthening ex with BFR training
Therapeutic strengthening training with blood flow restriction of trained limb.
• strengthening ex
Therapeutic strengthening training program for lower extremities.

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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