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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: 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

Conditions

Multiple Sclerosis

Being tested

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

Keywords

Multiple sclerosis, Exergaming, Nintendo Wii Fit, Nintendo Ring Fit Adventure, Physical therapy, Randomized controlled trial, Neurological rehabilitation

Medical subject headings

Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Conventional TherapyOther

  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.

• Nintendo Ring Fit Adventure + Conventional TherapyDevice

  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.

• Nintendo Wii Fit + Conventional TherapyDevice

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Physical Functional Capacity (6MWT)

   Physical functional capacity will be measured by 6-minute walk test (6MWT), a stress test that measures the maximum distance that an individual can travel during a period of six minutes walking as fast as possible. It will be carried out in a corridor 30 meters long, with a flat surface, preferably indoors and avoiding the traffic of people not involved in the test. Heart rate and O2 saturation (using a pulse oximeter) at the beginning and end of the test and the Borg scale (perception of effort) will also be compared.

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

2. Quality Of Life (MSQOL-54)

   The quality of life will be measured by the Multiple Sclerosis Specific Quality of Life Questionnaire (MSQOL-54). This questionnaire consists of 54 items distributed in 12 scales that measure the following dimensions of quality of life: physical health, limitations due to physical problems, limitations due to emotional problems, pain, emotional well-being, energy, health perception, social function, cognitive function, health concern, overall quality of life, sexual function, changes in health, satisfaction with sexual function. It was created from the SF-36, completing it with 18 additional items on specific aspects of multiple sclerosis.

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

3. Balance (Tinetti Balance Scale)

   The balance will be measured by the Tinetti Balance Scale. The scale qualifies the subject's static and dynamic balance during walking through 16 items, thus early detecting the risk of suffering a fall. The maximum score for static balance is 16 points and for balance during walking is 12 points, with the total sum of the scale being 28 points. It is considered a high risk of falls: less than 19 points; moderate risk of falls: from 19 to 23 points, and low or mild risk: from 24 to 28 points.

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

4. Strength in Lower Limbs (Handheld dynamometer)

   The strength in the lower limbs will be measured by a handheld dynamometer (HHD). The instrument for measuring the maximum isometric voluntary contraction of the muscles will be involved in the different joint movements. The protocol will consist of two consecutive maximum contractions for each muscle group, preceded by a warm-up test. Participants will first be shown the movement to be performed and then asked to perform it to confirm their understanding and begin the warm-up. The two measurements will be carried out continuously for 6 seconds with intervals of 30 seconds between contractions for greater performance. The final value will be the average of the two measurements made. The measurements will be carried out on the dominant lower limb in hip flexors, hip extensors, hip adductors, hip abductors, knee flexors, knee extensors, ankle flexors and ankle extensors muscles.

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

5. Spasticity in Lower Limbs (Modified Ashworth Scale)

   The spasticity in the lower limbs will be measured by Modified Ashworth Scale (MAS). This clinical tool will be used to assess muscle tone by measuring the level of resistance to passive movement. Compared to the original version, this scale includes the score 1+, thus existing a range between 0 (no increase in tone) and 4 (affected part rigid in flexion or extension) with 6 different options. These passive joint movements will be performed between 5-8 times (for a more reliable result) in 1 second from the position of maximum contraction of the muscle to be evaluated. The protocol will consist of carrying out the evaluation on a stretcher after 3 minutes of rest on it (thus avoiding the possible increase of muscle tone due to movement). Passive movements will be carried out in both lower limbs (starting with the left leg) in hip flexors, hip extensors, hip adductors, hip abductors, knee flexors, knee extensors, ankle flexors and ankle extensors muscles.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 Jan 2024
2. Study start1 Sep 2023
3. Primary completion31 Oct 2024
4. Study completion1 Jun 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Multiple SclerosisStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.