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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Duchenne Muscular Dystrophy; Virtual Reality; Spinal Muscular Atrophy; Neuromuscular Disease; Biofeedback
• Intervention / Treatment: Other: Virtual Reality Training; Other: Biofeedback Training; Other: Conventional rehabilitation

Detailed Description

We have 3 purposes:

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

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merve Kurt; Phone Number: +90 5537241324; Email: merveekurtt93@gmail.com
• Study Contact Backup: Name: Tülay Tarsuslu Şimşek; Phone Number: 2324124923; Email: tulay_tarsuslu@yahoo.com

Study Locations

• Turkey
  • Balcova
    • Izmir, Balcova, Turkey, 35340
      • Recruiting
      • Dokuz Eylül University
      • Contact: Tülay Tarsuslu Simsek, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Training; 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; 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.
Experimental: Biofeedback Training; 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; 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.
Other: Conventional Rehabilitation; 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; Participants will receive a 12-week conventional rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Functional Reaching Test	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.	1 Minute
Fall Frequency	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.	1 Minute
Muscle Strength Test with Hand Held Dinamometer	Upper and lower limb muscles strength will be evaluated with hand held dinamometer device. This device allows recording of muscle strength in kilograms.	20 minutes
Timed Up Go Test	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.	2 Minutes
Stair Climb Test	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.	2 Minutes
T-shirt Wear Remove Test	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.	2 Minutes
Stand Up from Supine Position Test	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.	1 Minutes

Collaborators and Investigators

• Sponsor: Merve Kurt
• Investigators: Study Director: Tülay Tarsuslu Şimşek, Professor Dr.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: virtual reality; motivation; neuromuscular disease; duchenne muscular dystrophy; biofeedback training; spinal Muscular Atrophy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; Muscular Disorders, Atrophic; Motor Neuron Disease; Muscular Dystrophies; Muscular Atrophy; Atrophy; Muscular Dystrophy, Duchenne; Muscular Atrophy, Spinal; Neuromuscular Diseases
• Other Study ID Numbers: Merve Kurt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The IPD may share when requested
• IPD Sharing Time Frame: IPD: Balance results, Functional Level, Diagnosis, demographic data
• IPD Sharing Access Criteria: The IPD may share when requested.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No