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Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability

NCT06381440

UnknownNA

Sponsor: University Hospital of Ferrara

Conditions: Multiple Sclerosis

Interventions: Lokomat device (Hocoma AG, Volketswil, Switzerland)., Conventional walking training

Countries: Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Ferrara, Emilia-Romagna, Italy