Blood Flow Restriction Training in Multiple Sclerosis

NCT06143930 | Unknown

• 1 other identifier: BFR in MS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• gait performance by Two-dimensional (2D) Motion Analysis system

  one week after the end of treatment

Study Arms (2)

The control group (A) will receive therapeutic strengthening training program for lower extremities.

ACTIVE COMPARATOR

low intensity strengthening exercise program

Other: strengthening ex

The study group (B) will receive strengthening training with blood flow restriction

ACTIVE COMPARATOR

the same selected low intensity resisted exercise program as group (A) with blood flow restriction

Other: strengthening ex with BFR training

Interventions

strengthening ex with BFR training OTHER

Therapeutic strengthening training with blood flow restriction of trained limb.

The study group (B) will receive strengthening training with blood flow restriction

strengthening ex OTHER

Therapeutic strengthening training program for lower extremities.

The control group (A) will receive therapeutic strengthening training program for lower extremities.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Multiple sclerosis patients with other neurological or orthopedic problems.
• Multiple sclerosis patients with systemic problems (cardiovascular or pulmonary diseases…).
• Patients with cognitive impairment.
• Pregnant female patients.
• Patients in acute relapse stage.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Giza, +20, Egypt

RECRUITING

Study Officials

• Habiba Zienhom

  Cairo University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Habiba Zienhom

CONTACT

01061209505; Habiba_future@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 22, 2023
• Study Start: July 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)