NCT06196866

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

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: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Universidad de Córdoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
DEVICE	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.
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-10-31
• Completion: 2025-06-01
• First posted: 2024-01-09
• Last updated: 2025-03-07

Locations

1 site across 1 country: Spain