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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital of Ferrara

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of other psychiatric or neurological disorders.

Cardiopulmonary, renal, or liver diseases.

Pregnancy.

Modifications in drug treatment within the last 3 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • High Intensity Task Oriented Circuit Training + Telerehabilitation

    Behavioral

    Participants will receive 10 sessions of high-intensity, task-oriented circuit training, three times a week. Each session will last 60 minutes, with minutes of active training. Each session will include three rounds, each lasting 55 minutes. During each round, participants will rotate between stations working for four minutes at each station, followed by three minutes of rest. The stations will focus on key motor skills, including supine to stand transitions, walking speed and functional capacity, walking adaptability and stepping. After in-hospital treatment participants will receive 36 sessions of asynchronous telerehabilitation, three times a week for 12 weeks. This intervention will be supported by low-cost, off-the-shelf technology for treatment delivery and monitoring.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Experimental: High Intensity Task Oriented Circuit Training + TelerehabilitationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Balance

The change in balance will be assessed using the Fullerton Advanced Balance Scale

Time frame
Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)

Secondary outcomes

1

Change in mobility, balance, walking ability, and fall risk

Mobility, balance, walking ability, and fall risk will be assessed through Timed Up and Go Test

Time frame
Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)
2

Change in Dual task Cost

Dual Task Cost will be assessed by the difference between Timed Up and Go and Dual Task Timed Up and Go

Time frame
Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)
3

Change in quantitative mobility and leg function performance

Leg function performance and quantitative mobility assessed through Timed 25 Foot Walk

Time frame
Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)
4

Change in auditory information processing speed and flexibility

Paced Auditory Serial Addition Test will be used to assess auditory information processing speed and flexibility

Time frame
Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)

Other outcomes

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