Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Severe Gait Impairment: A Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High intensity task oriented circuit training + Telerehabilitation.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Severe Gait Impairment Via High Intensity Task Oriented Circuit Training: A Feasibility Study
Overview
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.
Interventions
- Behavioral High intensity task oriented circuit training + Telerehabilitation
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, b
Primary outcome measures
- Change in Static Balance [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 outcome measures (12)
- Change in Walking capacity [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)]
- Change in Walking speed [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)]
- Change in mobility, balance, walking ability, and fall risk [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)]
- Change in quantitative mobility and leg function performance [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)]
- Change in 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)]
- Changes in functional lower extremity strength [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)]
- Change in cardiovascular fitness [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)]
- Change in Subjective Trait Fatigue [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)]
- Change in impacts of multiple sclerosis in people' lifes [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)]
- Change in balance confidence [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)]
- Change in functional performance of the upper extremity [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)]
- Change in self perceived manual ability [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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Ferrara University Hospital — Ferrara
Identifiers
NCT: NCT07058896 · UNLOCK_MS_SGI_HITOCT