Effectiveness of Exergaming in Adittion to Conventional Treatment for

Effectiveness of Two Different Exergaming Systems in Addition to Conventional Treatment for Physical Therapy in Patients with Multiple Sclerosis: a Study Protocol for a Multicenter, Assessor-blind, 24-week, Randomized Controlled Trial

Status unknownNot a drug-phase studyRelapsing and progressiveNCT06196866

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

  • Nintendo Ring Fit Adventure + Conventional Therapy
  • Nintendo Wii Fit + Conventional Therapy

Compared with

  • Conventional Therapy

What it measured

Main measures

  • Physical Functional Capacity (6MWT)

    Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).

    Walking and mobilityBladder, bowel and sexual function

  • Quality Of Life (MSQOL-54)

    Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).

    Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)

  • Balance (Tinetti Balance Scale)

    Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).

    Walking and mobility

  • Strength in Lower Limbs (Handheld dynamometer)

    Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).

    Physical function

  • Spasticity in Lower Limbs (Modified Ashworth Scale)

    Initial baseline assessment (week 1), assessment post-intervention 1 (week 12) and assessment post-intervention 2 (week 24).

    SpasticityBladder, bowel and sexual function

Who could take part

Relapsing and progressive · 18 and over

Show the full criteria

Inclusion criteria

(i) Diagnosis of MS in any of its types (clinically isolated syndrome, relapsing-remitting MS, primary progressive MS or secondary progressive MS) based on the McDonald criteria. (ii) Age over 18 years. (iii) Mini-Mental State Examination score > 19 points. (iv) Score on the Expanded Disability Status Scale (EDSS) under 7.0 points.

Exclusion criteria

(i) Diagnosis of another disease that affects balance and/or coordination. (ii) Exacerbation or steroid treatment in the 30 days prior to inclusion in the study. (iii) Presence of visual deficits.

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

About this trial

In the sponsor's words

The present study aims to evaluate the effectiveness of two different exergaming systems in addition to conventional treatment on physical functional capacity, balance, muscle strength, spasticity in lower limbs and quality of life compared to an isolated conventional intervention in patients with multiple sclerosis. The secondary aim will be to compare the differences between both exergaming groups.

Papers

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    History

    1. Status changed from Running, not recruiting to Status unknown
    2. Result signal changed from Ongoing to Status unknown

    1. Started

      Sept 2023

    2. Main results due

      Oct 2024

    3. Finished

      Jun 2025

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