Clinical trial NCT06143930: Blood Flow Restriction Training in Multiple Sclerosis
Official title: (Effect of Blood Flow Restriction Training on Muscle Strength and Gait Performance in Multiple Sclerosis Patients).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: MS
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: muscle strength
timeFrame: one week after the end of treatment
Secondary outcomes:
measure: gait performance by Two-dimensional (2D) Motion Analysis system
timeFrame: one week after the end of treatment
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
affiliation: Cairo University
name: Habiba Zienhom
role: PRINCIPAL_INVESTIGATOR
affiliation: professor of physical therapy,aculty of Physical therapy ,Cairo university
name: Dr.Moshera Hassan Darwish, professor
role: STUDY_DIRECTOR
affiliation: professor of Neurology, Faculty of Medicine,Cairo university
name: Dr Mohamed Soliman Al-Tamawy, professor
role: STUDY_DIRECTOR
References: