The Effect of a Telerehabilitation Virtual Reality Intervention on Functional Upper Limb Activities in People With Multiple Sclerosis

Status unknownNot a drug-phase studyMS (type not specified)NCT04032431

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

  • Telerehab VR intervention

What it measured

Main measures

  • Change in Nine Hole Peg Test (9HPT)

    Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline)

    Disability progressionArm and hand function

Other measures (3)

  • Action Research Arm Test (ARAT)

    Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)

    Arm and hand function
  • Manual Ability Measure-36 (MAM-36)

    Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)

    Arm and hand function
  • Value of "Impression of change" parameter

    Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline), 1 month follow-up (T2, +12 weeks from baseline)

    Arm and hand function

Who could take part

MS (type not specified) · 25 to 60

Show the full criteria

Inclusion criteria

1. diagnosis of MS according to the revised McDonald Criteria 2017; 2. aged 25-60 years old; 3. an Expanded Disability Status Scale score ≥6; 4. an ability to understand and execute simple instructions; 5. a cut-off score of >0.5 pegs/s(=18s) on the NHPT (selected due to its high discriminative and predictive ability in distinguishing ADL independence in pwMS).

Exclusion criteria

1. orthopedic and other neurological disorders affecting upper limb movements (e.g., epileptic seizures); 2. contra-indication to physical activity (e.g., heart failure, severe osteoporosis); 3. moderate or severe cognitive impairments as indicated by the Mini-Mental State Examination score \<21; 4. pregnancy (self-reported); 5. severe uncorrected visual deficits; 6. MS clinical relapse or treatment with corticosteroid therapy within 90 days prior to enrollment; 7. started or stopped a disease-modifying therapy for MS within 90 days prior to enrollment; 8. patients who received a course of physical or occupational therapy (home, outpatient or inpatient) within the past 30 days; 9. other treatments that could influence the effects of the interventions

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

About this trial

In the sponsor's words

This study aims to investigate the effectiveness of a home-based telerehabilitation program specifically designed for upper limbs, based on Virtual Reality (VR) in individuals affected by Multiple Sclerosis.

Papers

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History

    1. Started

      Dec 2020

    2. Main results due

      Sept 2021

    3. Finished

      Sept 2022

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