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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Definitive diagnosis of multiple sclerosis according to McDonald criteria;

• Age between 18 and 65 years;

• Pyramidal or cerebellar system with a score ≥ 2 on the EDSS;

• EDSS between 2 and 3;

• Ability to stand without support for 60 seconds;

• Stability of disease-modifying treatment and absence of clinical relapse of the disease for at least 1 year;

• Cognitive ability to execute simple orders and understand the physiotherapist's instructions \[assessed by Token Test (score ≥ 26.5)\];

• Ability to understand and sign informed consent.

Locations
Other Locations
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Roma
Contact Information
Primary
Silvia Giovannini, MD, phD
silvia.giovannini@policlinicogemelli.it
+390630154382
Backup
Letizia Castelli, MS
letizia.castelli@policlinicogemelli.it
+390630154382
Time Frame
Start Date: 2023-09-15
Estimated Completion Date: 2026-05
Participants
Target number of participants: 24
Treatments
Experimental: Experimental Group (HO, Hunova-Observation)
Patients in the HO group will undergo a specific rehabilitation treatment for balance disorders using the robotic platform Hunova® Movendo Technology srl, Genova, IT), for 4 weeks, 3 times a week for 45 minutes each. In particular, the technological rehabilitation carried out with the platform will have as main objective the improvement of balance, both in sitting and standing position, and static and dynamic exercises, dual-task exercises and exercises to improve trunk control will be proposed. Afterwards, patients will undergo 4 weeks of observation without rehabilitation treatment.
Active_comparator: Control Group (OH, Observation-Hunova)
Patients in the OH group will undergo 4 weeks of observation without rehabilitation treatment, followed by specific rehabilitation treatment for balance disorders using the robotic platform Hunova® Movendo Technology srl, Genova, IT), for 4 weeks, 3 times a week for 45 minutes each. In particular, the technological rehabilitation carried out with the platform will have as main objective the improvement of balance, both in sitting and standing position, and static and dynamic exercises, dual-task exercises and exercises to improve trunk control will be proposed.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov