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
Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT.
• 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