High-intensity circuit training plus home telerehab to improve walking and balance in people with mild-to-moderate MS
Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Mild to Moderate Gait Impairment Via High Intensity Task Oriented Circuit Training: A Feasibility Study
This project will test whether a short hospital-based high-intensity task-oriented circuit training program followed by three months of unsupervised telerehabilitation helps people with mild-to-moderate MS improve and maintain walking and balance.
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 | NCT07058870 on ClinicalTrials.gov |
What this trial studies
Participants complete ten one-hour high-intensity, task-oriented circuit training sessions in a hospital setting focusing on walking, stepping, supine-to-stand transitions, and general mobility. After the in-person program, participants follow three months of asynchronous telerehabilitation without real-time physiotherapist supervision to try to maintain gains. The study is a feasibility interventional protocol aimed at safety, tolerability, and preliminary signals of benefit on gait and balance. Outcomes will include measures of gait and balance functional capacity and the durability of any improvements over a six-month period.
Who should consider this trial
Good fit: Ideal candidates are adults with primary or secondary progressive MS who have mild-to-moderate gait impairment (EDSS ≤ 6), intact cognition (MMSE > 24), no major cardiopulmonary/renal/hepatic disease, stable medications for at least three months, and who are not pregnant.
Not a fit: People with more severe disability (EDSS > 6), significant cognitive impairment, unstable medical conditions, other active neurological or psychiatric disorders, recent medication changes, or who are pregnant are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve walking and balance in people with mild-to-moderate MS and provide a practical way to maintain those gains remotely.
How similar studies have performed: Previous studies of high-intensity and task-oriented training in MS have shown improvements in gait and balance and telerehabilitation has shown promising but mixed results, so combining these approaches is plausible though still being tested for feasibility.
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. 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.