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

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

About this trial

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.

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 ≥ 6.5.

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 12 sessions of high-intensity, task-oriented circuit training, three times a week for four weeks. Each session will last 180 minutes, with 108 minutes of active training. Each session will include three rounds, each lasting 51 minutes. During each round, participants will rotate between stations working for six minutes at each station, followed by three minutes of rest. The stations will focus on key motor skills, including sit-to-stand transitions, walking, standing, bed mobility and transfers, stepping, and wheelchair use. If participants are unable to walk, the walking station will be replaced by upper limb function station. After in-hospital treatment participants will receive 36 sessions of asynchronous telerehabilitation, three times a week for 12 weeks. Including monthly televisits with the physiotherapist. 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: High Intensity Task Oriented Circuit Training + TelerehabilitationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Static Balance

The change in static balance will be assessed using the Berg 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 Walking capacity

Walking capacity will be assessed through the 6 Minute Walking 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 Walking speed

Walking speed will be assesed through the 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)
3

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)
4

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)

Other outcomes

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