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

Primary Purpose

Neuromuscular Disease, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Training
Biofeedback Training
Conventional rehabilitation
Sponsored by
Merve Kurt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Disease focused on measuring motivation, neuromuscular disease, duchenne muscular dystrophy, spinal Muscular Atrophy, virtual reality, biofeedback training

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Virtual Reality Training

Biofeedback Training

Conventional Rehabilitation

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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.
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.
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".

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 26, 2018
Last Updated
June 16, 2022
Sponsor
Merve Kurt
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1. Study Identification

Unique Protocol Identification Number
NCT03689660
Brief Title
Feasibility of Virtual Reality in Children With Neuromuscular Disease, Effectiveness of Virtual Reality and Biofeedback
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Merve Kurt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Nope
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Training
Arm Type
Experimental
Arm Description
Virtual reality treatment will be applied during the 12 weeks. The training will consist of three sessions per week and 30 minutes per session.
Arm Title
Biofeedback Training
Arm Type
Experimental
Arm Description
Biofeedback training will be applied during the 12 weeks. The training will consist of three sessions per week and 30 minutes per session.
Arm Title
Conventional Rehabilitation
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Biofeedback Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
Participants will receive a 12-week conventional rehabilitation program.
Primary Outcome Measure Information:
Title
The Motor Function Measure-32
Description
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.
Time Frame
30 minutes
Title
Pediatric Functional Independence Measure
Description
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.
Time Frame
5 minutes
Title
Balance Master System
Description
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.
Time Frame
20 minutes
Title
Vignos Scale
Description
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).
Time Frame
2 Minutes
Title
Feasibility of Virtual Reality
Description
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.
Time Frame
1 Minutes
Title
Pediatric Motivation Scale
Description
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.
Time Frame
5 Minutes
Title
Visual Analog Scale
Description
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".
Time Frame
1 Minute
Secondary Outcome Measure Information:
Title
Pediatric Functional Reaching Test
Description
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.
Time Frame
1 Minute
Title
Fall Frequency
Description
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.
Time Frame
1 Minute
Title
Muscle Strength Test with Hand Held Dinamometer
Description
Upper and lower limb muscles strength will be evaluated with hand held dinamometer device. This device allows recording of muscle strength in kilograms.
Time Frame
20 minutes
Title
Timed Up Go Test
Description
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.
Time Frame
2 Minutes
Title
Stair Climb Test
Description
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.
Time Frame
2 Minutes
Title
T-shirt Wear Remove Test
Description
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.
Time Frame
2 Minutes
Title
Stand Up from Supine Position Test
Description
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.
Time Frame
1 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Kurt
Phone
5537241324
Ext
+90
Email
merveekurtt93@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tülay Tarsuslu Şimşek
Phone
2324124923
Email
tulay_tarsuslu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tülay Tarsuslu Şimşek
Organizational Affiliation
Professor Dr.
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
State/Province
Balcova
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tülay Tarsuslu Simsek, Prof.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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