Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.
Recruiting · NCT05983809 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Significant visual impairment, defined by a visual system score ≥ 2 on the EDSS;
- Presence of vestibular disorders unrelated to MS;
- Presence of psychiatric disorders or severe cognitive impairment, i.e. a Mini Mental State Examination (MMSE) score \< 24 (15);
- Presence of cardiovascular and respiratory disorders;
- Inability to provide informed consent.
Where it is running
1 location listed.
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma, RM, Italy