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Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Mild to Moderate Gait Impairment: A Feasibility Study (UNLOCK MS MGI)

U

University Hospital of Ferrara

Status

Enrolling

Conditions

Multiple Sclerosis

Treatments

Behavioral: High Intensity Task Oriented Circuit Training + Telerehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT07058870
UNLOCK_MS_MGI_HITOCT

Details and patient eligibility

About

The goal of this feasibility study is to test the safety and effectiveness of an high-intensity task oriented circuit training program, followed by three months of telerehabilitation in people with mild to moderate Multiple Sclerosis (MS). The main questions it aims to answer are:

  • Can high-intensity task oriented circuit training improve gait and balance functional capacity?
  • Can telerehabilitation mantain the benefits in gait and balance gained via circuit training for a six month period?

Participants will:

  • Complete 10 session ( one hour each, three times a week) of high-intensity task oriented circuit training administered in a hospital setting. The training will target key motor skills such as walking, stepping, supine to stand transitions and general mobility.
  • Engage in 3 months of asynchronous telerehabilitation (without physiotherapist supervision)

Enrollment

18 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of primary or secondary progressive multiple sclerosis according to the McDonald criteria.
  • Mini-Mental State Examination (MMSE) score > 24.
  • Expanded Disability Status Scale (EDSS) score ≤ 6.

Exclusion criteria

  • Presence of other psychiatric or neurological disorders.
  • Cardiopulmonary, renal, or liver diseases.
  • Pregnancy.
  • Modifications in drug treatment within the last 3 months.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Experimental: High Intensity Task Oriented Circuit Training + Telerehabilitation
Experimental group
Description:
Participants will receive 10 sessions (one hour each, three times a week) including structured exercise stations targeting key motor skills such as walking, walking adaptability, stepping and supine to stand transition. Afterwards, participants will engage in 36 sessions (30 minutes each, three times a week) of asynchronous telerehabilitation targeting supine to stand transition, stepping and walking.
Treatment:
Behavioral: High Intensity Task Oriented Circuit Training + Telerehabilitation

Trial contacts and locations

1

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Central trial contact

Sofia Straudi, MD, PhD

Data sourced from clinicaltrials.gov

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