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

NCT03689660 | Completed DMC

• 1 other identifier: Merve Kurt
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Disease; Duchenne Muscular Dystrophy; Spinal Muscular Atrophy; Virtual Reality; Biofeedback

Keywords

motivation; neuromuscular disease; duchenne muscular dystrophy; spinal Muscular Atrophy; virtual reality; biofeedback training

Outcome Measures

Primary Outcomes (7)

• The Motor Function Measure-32

  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.

  30 minutes

• Pediatric Functional Independence Measure

  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.

  5 minutes

• Balance Master System

  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.

  20 minutes

• Vignos Scale

  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).

  2 Minutes

• Feasibility of Virtual Reality

  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.

  1 Minutes

• Pediatric Motivation Scale

  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.

  5 Minutes

• Visual Analog Scale

  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".

  1 Minute

Secondary Outcomes (7)

• Pediatric Functional Reaching Test

  1 Minute

• Fall Frequency

  1 Minute

• Muscle Strength Test with Hand Held Dinamometer

  20 minutes

• Timed Up Go Test

  2 Minutes

• Stair Climb Test

  2 Minutes

Study Arms (3)

Virtual Reality Training

EXPERIMENTAL

Virtual reality treatment will be applied during the 12 weeks. The training will consist of three sessions per week and 30 minutes per session.

Other: Virtual Reality Training

Biofeedback Training

EXPERIMENTAL

Biofeedback training will be applied during the 12 weeks. The training will consist of three sessions per week and 30 minutes per session.

Other: Biofeedback Training

Conventional Rehabilitation

OTHER

Participants will continue this rehabilitation program if they are already getting rehabilitation in a rehabilitation center. If they do not participate in any rehabilitation program, they will be included in the conventional rehabilitation program by us.

Other: Conventional rehabilitation

Interventions

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.

Virtual Reality Training

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.

Biofeedback Training

Conventional rehabilitation OTHER

Participants will receive a 12-week conventional rehabilitation program.

Conventional Rehabilitation

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merve Kurt: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Balcova, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Muscular Dystrophy, Duchenne; Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Nervous System Diseases; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases

Study Officials

• Tülay Tarsuslu Şimşek

  Professor Dr.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Nope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: February 1, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD: Balance results, Functional Level, Diagnosis, demographic data
• Access Criteria: The IPD may share when requested.

Locations

TU (1)