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

Status unknownNot a drug-phase studyMS (type not specified)NCT05983809

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Technological rehabilitation

What it measured

Main measures

  • Berg Balance Scale

    Change from Baseline BBS at 4 and 8 weeks

    Walking and mobility

Other measures (15)

  • Modified Fatigue Impact Scale (MFIS)

    Change from Baseline MFIS at 4 and 8 weeks

    Thinking and memoryFatigueArm and hand function
  • Fatigue Scale for Motor and Cognitive Function (FSMC)

    Change from Baseline FSMC at 4 and 8 weeks

    Thinking and memoryFatigue
  • Timed Up and Go test (TUG)

    Change from Baseline TUG at 4 and 8 weeks

    Walking and mobility
  • Ambulation Index (AI)

    Change from Baseline Ambulation Index at 4 and 8 weeks

    Walking and mobility
  • Walking handicap scale (WHS)

    Change from Baseline Walking handicap scale at 4 and 8 weeks

    Walking and mobilityPhysical function
  • Functional Ambulation Classification (FAC)

    Change from Baseline Functional Ambulation Classification at 4 and 8 weeks

    VisionWalking and mobility
  • 10 Meter Walk Test (10mWT)

    Change from Baseline 10 Meter Walk Test at 4 and 8 weeks

    Walking and mobility
  • Six-minute walk test (6MWT)

    Change from Baseline Six-minute walk test at 4 and 8 weeks

    Walking and mobilityPhysical function
  • Multiple Sclerosis Walking Scale (MSWS-12)

    Change from Baseline Multiple Sclerosis Walking Scale at 4 and 8 weeks

    Walking and mobility
  • Modified Barthel Index (mBI)

    Change from Baseline mBI at 4 and 8 weeks

    Walking and mobilityBladder, bowel and sexual function

Who could take part

MS (type not specified) · 18 to 65

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

  1. Status changed from Recruiting to Status unknown
  1. Started

    Sept 2023

  2. Main results due

    Mar 2024

  3. Finished

    May 2026

Assembled by software from public sources.