Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.

Condition(s) studied

Investigational drug(s) / intervention(s)

Technological rehabilitation: Specific rehabilitation for balance disorder using the robotic platform

Study 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

Primary outcome measure(s)

• Berg Balance Scale — Change from Baseline BBS at 4 and 8 weeks
  The Berg Balance Scale (BBS) is used to objectively determine a patient's ability(or inability) to safely balance during a series of predetermined tasks. It is a 14item list with each item consisting of a five-point ordinal scale ranging from 0 to 4,with 0 indicating the lowest level of function and 4 the highest level of function andtakes approximately 20 minutes to complete. It does not include the assessmentof gait.

Trial sites (1)

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

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