Effectiveness of Exergaming in Adittion to Conventional Treatment for Physical Therapy in People with Multiple Sclerosis

Universidad de Córdoba

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Device: Nintendo Ring Fit Adventure + Conventional Therapy; Device: Nintendo Wii Fit + Conventional Therapy; Other: Conventional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06196866

ESCMU01

Details and patient eligibility

About

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.

Full description

Multiple sclerosis is a chronic autoimmune inflammatory disease of the central nervous system, which produces demyelination and axonal damage in the brain and spinal cord. Since there is currently no treatment for this condition, the goal of rehabilitation is to assist people with their manifestations. Over the last decade, exergaming with commercial consoles has demonstrated potential benefits in managing motor and functional impairments. However, new videogame strategies and assessment in randomized controlled trials are necessary to obtain significant results in different outcomes.

The hypothesis is that the exergaming systems in addition to conventional treatment will show statistically significant improvements on motor skills, spasticity, and quality of life results compared to conventional therapy alone. Therefore, this project 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 investigators here design a multi-center, assessor-blind, 24-weeks, randomized controlled trial protocol. The achievement of the present project would serve to analyze the benefits of an alternative exercise program in the motor and functional rehabilitation program of multiple sclerosis patients and to identify the subjects in whom the benefits would be greater and whose implementation would have greater priority.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Control group

Active Comparator group

Description:

Participants carry out daily routine activities and/or receive standard physiotherapy for the whole 24 weeks of the trial, 1 session/week with a time of 45 minutes/session.

Treatment:

Other: Conventional Therapy

Exergaming group 1

Experimental group

Description:

Participants receive Nintendo Ring Fit Adventure exergaming intervention for 12 weeks, 1 session/week with a time of 45 minutes/session + Control group intervention.

Treatment:

Device: Nintendo Ring Fit Adventure + Conventional Therapy

Exergaming group 2

Experimental group

Description:

Participants receive Nintendo Wii Fit exergaming intervention for 12 weeks, 1 session/week with a time of 45 minutes/session + Control group intervention.

Treatment:

Device: Nintendo Wii Fit + Conventional Therapy