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Blood Flow Restriction Training in Multiple Sclerosis

NCT ID: NCT06143930

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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MS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

low intensity strengthening exercise program

Group Type ACTIVE_COMPARATOR

strengthening ex

Intervention Type OTHER

Therapeutic strengthening training program for lower extremities.

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

Group Type ACTIVE_COMPARATOR

strengthening ex with BFR training

Intervention Type OTHER

Therapeutic strengthening training with blood flow restriction of trained limb.

Interventions

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strengthening ex with BFR training

Therapeutic strengthening training with blood flow restriction of trained limb.

Intervention Type OTHER

strengthening ex

Therapeutic strengthening training program for lower extremities.

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Habiba Zienhom Soubhy Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Habiba Zienhom

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Dr.Moshera Hassan Darwish, professor

Role: STUDY_DIRECTOR

professor of physical therapy,aculty of Physical therapy ,Cairo university

Dr Mohamed Soliman Al-Tamawy, professor

Role: STUDY_DIRECTOR

professor of Neurology, Faculty of Medicine,Cairo university

Locations

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Faculty of physical therapy

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Habiba Zienhom

Role: CONTACT

[email protected]
01061209505 ext. 002

Other Identifiers

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BFR in MS

Identifier Type: -

Identifier Source: org_study_id