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

Duchenne Muscular Dystrophy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03689660
• Other study ID #: Merve Kurt
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: October 1, 2023

Study information

• Verified date: June 2022
• Source: Dokuz Eylul University
• Contact: Merve Kurt
• Phone: 5537241324
• Email: merveekurtt93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Biofeedback
• Duchenne Muscular Dystrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Neuromuscular Disease
• Neuromuscular Diseases
• Spinal Muscular Atrophy
• Virtual Reality

Intervention

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.
• 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.
• Conventional rehabilitation
Participants will receive a 12-week conventional rehabilitation program.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir	Balcova

Sponsors (1)

Lead Sponsor	Collaborator
Merve Kurt

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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