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

NCT ID: NCT06196866

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-06-01

Brief Summary

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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type: OTHER

The control group will develop only conventional treatment for the whole trial (weeks 1-24), consisting of carrying out daily routine activities and/or 1 session/week of physiotherapy (which includes manual therapy, active exercises of repetition of functional movements, walking, stairs and stretching) with a time of 45 minutes/session.

Exergaming group 1

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

Group Type: EXPERIMENTAL

Nintendo Ring Fit Adventure + Conventional Therapy

Intervention Type: DEVICE

In the exergaming group 1, the intervention will be 12 weeks (weeks 1-12) with a frequency of 1 session/week and with a time of 45 minutes/session, in addition to the users' conventional therapy. The training will be a first 5 minutes warm-up (composed of joint mobility and global stretching), 35 min of exergaming training (working on the participants' gait, stability and global muscle strength) and last 5 minutes of cooling down (composed of breathing exercises, joint mobility and global stretching) in each session. The therapist will choose in each session different exercises from each of these 4 sections:

Jogging: Begginia or Transient Temple.

Minigames: Squat Goals, Squattery Wheel, Gluting Gallery, Thigh Rider, Bank Balance or Dreadmill.

Lower Limbs Training: Knee Lift or Hip Lift.

Yoga: Tree Pose or Chair Pose.

Exergaming group 2

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

Group Type: EXPERIMENTAL

Nintendo Wii Fit + Conventional Therapy

Intervention Type: DEVICE

In the exergaming group 2, the intervention will be 12 weeks (weeks 1-12) with a frequency of 1 session/week and with a time of 45 minutes/session, in addition to the users' conventional therapy. The training will be a first 5 minutes warm-up (composed of joint mobility and global stretching), 35 min of exergaming training (working on the participants' gait, stability and global muscle strength) and last 5 minutes of cooling down (composed of breathing exercises, joint mobility and global stretching) in each session. The therapist will choose in each session different exercises from each of these 4 sections:

Aerobics: Basic Run or Hula Hoop.

Strength Training: Rowing Squat, Single-Leg Extension, Sideways Leg Lift or Single-Leg Twist.

Balance Games: Ski Jump, Balance Bubble, Table Tilt or Penguin Slide.

Yoga: Chair or Standing Knee.

Interventions

Conventional Therapy

The control group will develop only conventional treatment for the whole trial (weeks 1-24), consisting of carrying out daily routine activities and/or 1 session/week of physiotherapy (which includes manual therapy, active exercises of repetition of functional movements, walking, stairs and stretching) with a time of 45 minutes/session.

Intervention Type: OTHER

Nintendo Ring Fit Adventure + Conventional Therapy

In the exergaming group 1, the intervention will be 12 weeks (weeks 1-12) with a frequency of 1 session/week and with a time of 45 minutes/session, in addition to the users' conventional therapy. The training will be a first 5 minutes warm-up (composed of joint mobility and global stretching), 35 min of exergaming training (working on the participants' gait, stability and global muscle strength) and last 5 minutes of cooling down (composed of breathing exercises, joint mobility and global stretching) in each session. The therapist will choose in each session different exercises from each of these 4 sections:

Jogging: Begginia or Transient Temple.

Minigames: Squat Goals, Squattery Wheel, Gluting Gallery, Thigh Rider, Bank Balance or Dreadmill.

Lower Limbs Training: Knee Lift or Hip Lift.

Yoga: Tree Pose or Chair Pose.

Intervention Type: DEVICE

Nintendo Wii Fit + Conventional Therapy

In the exergaming group 2, the intervention will be 12 weeks (weeks 1-12) with a frequency of 1 session/week and with a time of 45 minutes/session, in addition to the users' conventional therapy. The training will be a first 5 minutes warm-up (composed of joint mobility and global stretching), 35 min of exergaming training (working on the participants' gait, stability and global muscle strength) and last 5 minutes of cooling down (composed of breathing exercises, joint mobility and global stretching) in each session. The therapist will choose in each session different exercises from each of these 4 sections:

Aerobics: Basic Run or Hula Hoop.

Strength Training: Rowing Squat, Single-Leg Extension, Sideways Leg Lift or Single-Leg Twist.

Balance Games: Ski Jump, Balance Bubble, Table Tilt or Penguin Slide.

Yoga: Chair or Standing Knee.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Alvaro Alba Rueda

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amaranta De Miguel Rubio, PhD

Role: STUDY_DIRECTOR

Universidad de Córdoba

David Lucena Anton, PhD

Role: STUDY_DIRECTOR

University of Cadiz

Locations

University of Cordoba

Córdoba, Cordoba, Spain

Countries

Spain

Other Identifiers

ESCMU01

Identifier Type: -

Identifier Source: org_study_id