Clinical trial NCT05983809: Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.
Official title: Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis: Effects on Functional, Motor and Cognitive Outcomes (ROAR-MS).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Balance
Cognitive Impairment
Keywords: Rehabilitation
Multiple Sclerosis
Technology
Balance
Cognitive Impairment
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Interventional, randomised, controlled, cross-over pilot study.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Twenty-four patients of both sexes will be recruited, evaluated and treated at the Multiple Sclerosis UOS of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome from the date of approval of the study by the ethics committee and for the following 12 months, meeting the inclusion criteria. Patients will be divided into two groups by randomisation: one group (experimental group, HO, Hunova-Observation) will perform specific rehabilitation for balance disorder using the robotic platform Hunova® Movendo Technology srl, Genova, IT), followed by 4 weeks of observation. The other group (OH, Observation-Hunova) will instead carry out 4 weeks of observation, at the end of which they will carry out the specific treatment for the balance disorder using the robotic platform Hunova® Movendo Technology srl, Genova, IT).

Eligibility criteria: 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.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Change from Baseline BBS at 4 and 8 weeks
Secondary outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from Baseline MFIS at 4 and 8 weeks
measure: Fatigue Scale for Motor and Cognitive Function (FSMC)
timeFrame: Change from Baseline FSMC at 4 and 8 weeks
measure: Timed Up and Go test (TUG)
timeFrame: Change from Baseline TUG at 4 and 8 weeks
measure: Ambulation Index (AI)
timeFrame: Change from Baseline Ambulation Index at 4 and 8 weeks
measure: Walking handicap scale (WHS)
timeFrame: Change from Baseline Walking handicap scale at 4 and 8 weeks
measure: Functional Ambulation Classification (FAC)
timeFrame: Change from Baseline Functional Ambulation Classification at 4 and 8 weeks
measure: 10 Meter Walk Test (10mWT)
timeFrame: Change from Baseline 10 Meter Walk Test at 4 and 8 weeks
measure: Six-minute walk test (6MWT)
timeFrame: Change from Baseline Six-minute walk test at 4 and 8 weeks
measure: Multiple Sclerosis Walking Scale (MSWS-12)
timeFrame: Change from Baseline Multiple Sclerosis Walking Scale at 4 and 8 weeks
measure: Modified Barthel Index (mBI)
timeFrame: Change from Baseline mBI at 4 and 8 weeks
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Change from Baseline MSIS-29 at 4 and 8 weeks
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Change from Baseline BDI-II at 4 and 8 weeks
measure: State-Trait Anxiety Inventory (STAI-Y1 and Y2)
timeFrame: Change from Baseline STAI-Y1 and Y2 at 4 and 8 weeks
measure: Stroop Colour Word Test (SCWT)
timeFrame: Change from Baseline SCWT at 4 and 8 weeks
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from Baseline SDMT at 4 and 8 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Silvia Giovannini, MD, phD
role: PRINCIPAL_INVESTIGATOR
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