NCT07058896 Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Severe Gait Impairment: A Feasibility Study
| NCT ID | NCT07058896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital of Ferrara |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2024-10-28 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07058896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07058896 currently recruiting?
Yes, NCT07058896 is actively recruiting participants. Contact the research team at sofia.straudi@unife.it for enrollment information.
Where is the NCT07058896 trial being conducted?
This trial is being conducted at Ferrara, Italy.
Who is sponsoring the NCT07058896 clinical trial?
NCT07058896 is sponsored by University Hospital of Ferrara. The trial plans to enroll 18 participants.
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