RecruitingNot ApplicableNCT05983809

Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.

Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis: Effects on Functional, Motor and Cognitive Outcomes (ROAR-MS).


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

24 participants

Start Date

Sep 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Multiple sclerosis (MS) is a chronic, inflammatory and neurodegenerative disease of the central nervous system that often results in motor and/or cognitive impairment. Epidemiologically, the onset occurs between the ages of 20 and 40, with a peak around the age of 30. MS is an extremely heterogeneous disease in terms of signs and symptoms, both in terms of the neurological systems involved and the degree of impairment and severity. The most common symptoms include, among others, difficulty walking and lack of balance. The lack of stability and coordination reduces independence and mobility, predisposing people with MS to accidental falls and compromising mobility in daily life. Another symptom that characterises MS is cognitive impairment, which mainly alters information processing speed and short- and long-term memory. MS-related cognitive impairment is detectable at every stage of the disease. Very often, people with MS have co-existing cognitive and motor deficits, which add to the complexity of managing MS. In order to address this condition, a treatment strategy that combines cognitive and motor rehabilitation needs to be identified. Despite the increasing availability of effective drug therapies that may impact on balance, rehabilitation is a very important means to counteract the progression of disability and improve physical function, affecting social participation and improving quality of life. In recent years, rehabilitation makes use of various robotic devices, which are based on repeatable, intense and motivating exercises, integrated with an enriched virtual environment, capable of improving the quality of movement. In light of the literature, which mainly focuses on robotic therapy for walking, this pilot study aims to evaluate the effects of a specific robotic treatment for balance in MS patients. The primary objective of the study is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT) on static balance. The secondary objective is the evaluation of the effects of technological rehabilitation by means of a robotic platform (Hunova® Movendo Technology srl, Genoa, IT) 1. on dynamic balance and walking (assessed with clinical and instrumental scales) 2. on fatigue and cognitive performance in terms of sustained attention, dual-task cost and cognitive-motor interference; 3. on quality of life.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a technology-assisted rehabilitation program for people with multiple sclerosis (MS) to improve their balance and ability to walk, using devices such as balance platforms, treadmills with body support, and virtual reality tools. **You may be eligible if:** - You have a confirmed diagnosis of multiple sclerosis - You are 18–65 years old with mild-to-moderate disability (EDSS score 2–3) - You can stand without support for at least 60 seconds - Your MS treatment has been stable and you have had no relapses for at least 1 year - You can understand and follow instructions **You may NOT be eligible if:** - You have significant vision impairment related to MS - You have vestibular (inner ear balance) disorders unrelated to MS - You have severe cognitive impairment or a major psychiatric condition - You have cardiovascular or respiratory problems that prevent safe exercise Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETechnological rehabilitation

Specific rehabilitation for balance disorder using the robotic platform


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

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NCT05983809


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