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Completed

NCT Number: NCT03689660

Feasibility of Virtual Reality in Children With Neuromuscular Disease, Effectiveness of Virtual Reality and Biofeedback

Our study is a randomized controlled study and the subjects included in the study will be divided into three groups as virtual reality training, biofeedback training, and conventional rehabilitation.

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Key information

About this study

We have 3 purposes:

  • Determine the feasibility of virtual reality training in children with neuromuscular disease.
  • To determine the effect of virtual reality, biofeedback training, and conventional rehabilitation on functional levels and balances of children with neuromuscular disease.
  • To compare the motivation of children with neuromuscular disease to virtual reality, biofeedback training, and conventional rehabilitation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteer to participate in the study
  • Being diagnosed with the neuromuscular disease
  • No other systemic or neurological disease
  • No significant visual or auditory loss
  • Continuation of ambulation (10 m walking independently)
  • Be able to understand simple commands

Exclusion criteria

  • Performing a drug change at 3 months before treatment or during treatment which may affect muscle strength
  • Acute inflammation in the musculoskeletal system
  • Finding any orthopedic problem that prevents activities during the research

Treatment and study plan

Virtual Reality Training

Other

Participants will be given a game-based workout program that includes balance and weight transfers using the XBOX Kinect ™ device in a low-to-medium intensity for 3 weeks, 3 days a week, 30 minutes per day.

Biofeedback training

Other

biofeedback training will be applied to participants in 10-minute sessions with 10 seconds of voluntary contraction and 15 seconds of rest at each session. Training will last 12 weeks.

conventional rehabilitation

Other

Participants will receive a 12-week conventional rehabilitation program.

Primary outcomes

  1. The Motor Function Measure-32

    Time frame: 30 minutes

    MFM-32 is a scale developed to evaluate motor functions of children and adults with neuromuscular disease. The scale can be used to evaluate both in children with and without walking problems.The MFM-32 consists of 32 items. Each item is answered with a 4-point likert scale (0 = cannot initiate the exercise or maintain its starting position, 1 = partially completes the exercise, 2 = completes exercises with compensations, slowly or roughly, 3 = completes the exercise in the standard pattern). The scale can be used for the evaluation of individuals aged between 6 and 60 years.

  2. Pediatric Functional Independence Measure

    Time frame: 5 minutes

    WeeFIM consists of 18 items divided into 6 sub-scales (self-care, sphincter control, mobility, locomotion, communication, social communication). Each item is scored from 1 to 7. A higher score indicates a better functional level.

  3. Balance Master System

    Time frame: 20 minutes

    The static and dynamic balance evaluated using the Balance Master System ver. 8.1. (NeuroCom International Inc. Clackamas, OR, USA) force platform system which has multiple testing protocols designed to examine balance. The system includes a computer linked force plate that records data with the aid of crystal transducers.

  4. Vignos Scale

    Time frame: 2 Minutes

    The Vignos Scale has been developed to evaluate the lower extremity functions. The scale allows the lower extremity functions to be scored between 1 (can walk and climb stairs without help) and -10 (bed dependent).

  5. Feasibility of Virtual Reality

    Time frame: 1 Minutes

    The feasibility of virtual reality will be examined by laboratory tests. Laboratory tests to be carried out are as follows: Creatine Kinase, Lactate Dehydrogenase (LDH), Myoglobin, Serum Electrolytes, C-Reactive Protein levels. These are agents that are indicative of muscle destruction or inflammation. Will be evaluated in order to follow muscle destruction.

  6. Pediatric Motivation Scale

    Time frame: 5 Minutes

    The PMOT is recommended for assessing motivation to rehabilitation program in children aged 8 to 18 years. It comprises six subscales (effort-importance, interest-enjoyment, competence, relatedness, autonomy, and value-usefulness) with total 21 items. While the 19 items of the scale are answered with a 6-point smiley face scale (1 = absolutely false, 6 = absolutely correct), there are 2 open-ended questions on the scale. The high scores in each sub-scales indicate that the child's motivation in that sub-section is high. A higher total score indicates that the motivation is intrinsically arranged and that the child has a high motivation. From this point of view, the scale gives information about both the type of motivation and the amount of motivation of the child.

  7. Visual Analog Scale

    Time frame: 1 Minute

    Visual Analog Scale will be applied to evaluate muscle pain. It has a fixed line between two end adjectives of 100 mm length. The end adjectives in our study will be "no pain" and "too much pain".

Secondary outcomes

  1. Pediatric Functional Reaching Test

    Time frame: 1 Minute

    For the Pediatric Functional Reach test, children will be asked to raise their arms 90o in an upright posture position, extending to the maximum possible distance in three directions, forward, right, and left. Reach distances will be measured by pointing the wall with the end point of the third finger, and distances; "start", "final" and "difference" will be determined in cm using tape measure.

  2. Fall Frequency

    Time frame: 1 Minute

    The frequency of the fall will be questioned with a chart created by the researchers. The family will be asked to record the children's each fall a week before the study and a week after the treatment.

  3. Muscle Strength Test with Hand Held Dinamometer

    Time frame: 20 minutes

    Upper and lower limb muscles strength will be evaluated with hand held dinamometer device. This device allows recording of muscle strength in kilograms.

  4. Timed Up Go Test

    Time frame: 2 Minutes

    For the time up go test, children will be asked to walk with two walking cones at a distance of 10 meters, at normal walking speeds, and the elapsed time will be recorded in seconds.

  5. Stair Climb Test

    Time frame: 2 Minutes

    Children will be asked to climb up and down as quickly as they can, without running the steps, on a ladder of 16-20 cm height and 8-14 steps and the elapsed time will be recorded in seconds.

  6. T-shirt Wear Remove Test

    Time frame: 2 Minutes

    For the T-shirt pull-out test, the children will be asked to wear a T-Shirt in the sitting position as soon as possible and the elapsed time will be recorded in seconds; then they will be asked to remove the T-Shirt as soon as possible and the elapsed time will be recorded in seconds.

  7. Stand Up from Supine Position Test

    Time frame: 1 Minutes

    From the supine position to stand up, children will be asked to lie on the back of the body, the arms next to the body, the legs as closed as possible, and the head on the midline on a mat. Then, from this position, they will be asked to stand as soon as possible and the elapsed time will be recorded in seconds.

Sponsors and collaborators

Lead sponsor

Merve Kurt

Other

Registry information

Official study title

The Feasibility of Virtual Reality in Children With Neuromuscular Disease and the Effectiveness of Virtual Reality and Biofeedback Training on Functional Levels of Children With Neuromuscular Disease

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2018
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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