Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Severe Gait Impairment: A Feasibility Study (UNLOCK MS SGI)

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

NCT07058896

UNLOCK_MS_SGI_HITOCT

Details and patient eligibility

About

Multiple sclerosis (MS) is a progressive neurological disorder that often leads to severe gait impairment, limiting mobility and reducing the patient's quality of life. Motor rehabilitation has shown positive effects in people with MS (PwMS), but its efficacy tends to decrease as disability severity increases. High-intensity, task-oriented circuit training based on the principles of motor learning has been proposed as a potential strategy to improve motor function in severely impaired individuals.

This approach combines the benefits of high-intensity training to the motor learning principles to enhance motor skills improvement and retention.

The main questions it aims to answer are:

• Can high-intensity, task oriented training in PwMS with severe gait impairment be feasible, safe and effective in enhancing motor function?
• Can telerehabilitation maintain the benefits in gait and balance gained via circuit training for a six month period?

Participants will:

• Complete 12 session ( three 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, sit to stand, wheelchair, standing and bed mobillity.
• Engage in 3 months of asynchronous telerehabilitation (without physiotherapist supervision), including monthly televisits.

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 ≥ 6.5.

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)

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18 participants in 1 patient group

High Intensity Task Oriented Circuit Training + Telerehabilitation

Experimental group

Description:

Participants will receive 12 sessions of high-intensity, task-focused circuit training, three times a week for four weeks. Each 180-minute session includes 108 minutes of active training, with three rounds of exercises at different stations. Activities will focus on motor skills like standing, walking, transfers, and wheelchair use. If walking isn't possible, upper limb training will be included instead. After hospital treatment, participants will continue with 36 asynchronous telerehabilitation sessions over 12 weeks, including monthly televisits, using low-cost, commercially available technology.

Treatment:

Behavioral: High intensity task oriented circuit training + Telerehabilitation