Comparing two types of robot-assisted walking training for people with multiple sclerosis
Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability: Study Protocol for a the PROGR-EX Randomized-controlled Trial
This study is testing if a new type of robot-assisted walking training that gradually gets harder can help people with severe walking difficulties from multiple sclerosis move better without making them feel more tired or stiff.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 1 site (Ferrara, Emilia Romagna) |
| Trial ID | NCT06381440 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of low-intensity robot-assisted gait training (RAGT) that progressively increases in intensity compared to conventional RAGT and overground gait training (OGT) in individuals with multiple sclerosis (MS) who have severe walking disabilities. The trial will recruit 24 participants who will undergo three weekly treatment sessions for four weeks, focusing on stretching, muscle strengthening, and specific gait training. The aim is to determine if the progressive low-intensity approach can improve mobility without exacerbating fatigue or spasticity, which are common issues in MS patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with primary or secondary progressive multiple sclerosis, exhibiting moderate to severe walking impairment.
Not a fit: Patients with other neurological conditions affecting motor function or those with severe spasticity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mobility and quality of life for patients with severe gait disabilities due to multiple sclerosis.
How similar studies have performed: Previous studies have shown effectiveness of robot-assisted gait training in MS, but this specific approach of low-intensity progressive training is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of MS (primary or secondary progressive) without relapses in the preceding 3 months * Disability rate defined by Expanded Disability Status Scale (EDSS) score from 6 to 7 * Ability to perform the Timed 25-Foot Walk (T25-FW) test * Mini-Mental Status Examination score ≥ 24/30 Exclusion Criteria: * Other (neurological) conditions that may affect motor function * Medical conditions might interfere with the ability to complete the study protocol safely * Presence of spasticity with a Modified Ashworth Scale (MAS) score \> 3 or retractions limiting the range of motion of the hip, knee or ankle * MS relapses or medication changes or any other confounding factors during the study period * Rehabilitation treatment or botulinum toxin injection in the 3 months preceding the start of the study
Where this trial is running
Ferrara, Emilia Romagna
- Department of Neuroscience and Rehabilitation, University Hospital of Ferrara — Ferrara, Emilia Romagna, Italy (Recruiting)
Study contacts
- Principal investigator: Fabio Manfredini, PhD — Ferrara University
- Study coordinator: Sofia Straudi, PhD
- Email: sofia.straudi@unife.it
- Phone: 0532238720
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.