Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation

Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation in Patients with Multiple Sclerosis

Status unknownNot a drug-phase studyMS (type not specified)NCT06820125

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Cognitive rehabilitation: CG group
  • Motor rehabilitation: MG group
  • Combined rehabilitation: CbG group

What it measured

Main measures

  • Symbol Digit Modalities Test

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment

    Thinking and memory

  • 2-minute walking test

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment

    Walking and mobility

Other measures (12)

  • Brief Repeatable Battery (BRB)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory

  • The Stroop Test (ST)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory

  • Trail Making Test (TMT)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory

  • The Verbal Fluency Test (VF)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

  • The Modified Five Point Test (MFPT)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

  • Test of Attentional Performance (TAP; version 2.3.1)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory

  • N-Back task

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

  • Time up and Go (TUG)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memoryWalking and mobility

  • eight-infrared camera system (sampling frequency: 60-120 fps) with the VICON Vero 2.2 motion analysis system (Vicon Motion Analysis System Ltd),

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Walking and mobility

  • Modified Fatigue Impact Scale (MFIS)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Fatigue

Who could take part

MS (type not specified) · 18 and over · EDSS 3 to 6

Show the full criteria

Inclusion criteria

* presence of mild (one or two neuropsychological tests below the cut-off score, 5th percentile) or severe (more than two neuropsychological tests below the cut-off score, 5th percentile) cognitive impairment, * mild to moderate walking disability with Expanded Disability Status Scale (EDSS) between 3 and 6, * no relapse or associated steroid use in the past three months, * adequate visual and auditory capacity to operate computer software.

Exclusion criteria

* presence of other neurological disorders than MS, * major psychiatric disorders, * high levels of anxiety and/or depression (score>20 for Depression scale and up to 14 for Anxiety scale on Italian adaptation of the Depression, Anxiety and Stress Scale (DASS-21), * substance abuse, * any type of rehabilitation intervention in the month prior to recruitment * pharmacological therapy not well defined and/or changed during the study * presence of paroxysmal vertigo * lower limb botulinum toxin injections within the previous 12 weeks

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

About this trial

In the sponsor's words

The first aim of this project is to investigate the effects of different high-tech neurorehabilitation interventions (cognitive, motor, and combined cognitive-motor) on both cognitive and motor disability outcomes in people with multiple sclerosis (MS). The second aim is to identify the cognitive and motor profiles of MS patients who benefit the most from either the combined cognitive-motor rehabilitation intervention or the isolated cognitive or motor treatments.

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History

  1. Status changed from Recruiting to Status unknown
  2. Result signal changed from Ongoing to Status unknown

  1. Started

    Jul 2023

  2. Main results due

    Jul 2023

  3. Finished

    Jul 2026

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