Optimizing and reinforcing walking skills in people with severe multiple sclerosis using high-intensity circuit training and telerehabilitation.
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
This trial will try a short program of high-intensity, task-focused circuit training followed by six months of telerehabilitation to improve walking and balance in people with progressive MS who have severe gait problems (EDSS ≥6.5).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 1 site (Ferrara, FE) |
| Trial ID | NCT07058896 on ClinicalTrials.gov |
What this trial studies
Adults with primary or secondary progressive MS, preserved cognition (MMSE >24), and marked gait impairment (EDSS ≥6.5) will complete a supervised high-intensity, task-oriented circuit training program (about 12 sessions) to practice and consolidate motor skills. After the supervised phase, participants will be offered a telerehabilitation program intended to maintain gains over a six-month follow-up. The study will monitor feasibility, safety, and changes in gait and balance using standardized outcome measures at baseline, post-intervention, and during follow-up. The intervention is delivered at Ferrara University Hospital with remote components for the maintenance phase.
Who should consider this trial
Good fit: Ideal candidates are adults with primary or secondary progressive MS, EDSS ≥6.5, MMSE >24, stable on medications for at least three months, and without major cardiopulmonary, renal, liver, psychiatric, or other neurological comorbidities.
Not a fit: People with significant medical comorbidities, cognitive impairment (MMSE ≤24), recent medication changes, pregnancy, or who cannot attend in-person sessions at the Ferrara site are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could improve walking ability and balance in people with severe MS and help them keep those gains at home through telerehabilitation.
How similar studies have performed: Previous motor rehabilitation and high-intensity training studies have shown benefits for walking in people with MS, but evidence specifically for those with severe gait impairment and for sustaining gains via telerehabilitation is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ferrara, FE
- Ferrara University Hospital — Ferrara, Fe, Italy (Recruiting)
Study contacts
- Study coordinator: Sofia Straudi, MD, PhD
- Email: sofia.straudi@unife.it
- Phone: +390532238720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.