Neuromuscular DiseaseNCT03689660
Feasibility of Virtual Reality in Children With Neuromuscular Disease, Effectiveness of Virtual Reality and Biofeedback
A study testing Virtual Reality Training, Biofeedback Training and Conventional rehabilitation in people with Neuromuscular Disease and Duchenne Muscular Dystrophy, run by Merve Kurt at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Neuromuscular Disease, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy
- What is being tested?
- Virtual Reality Training, Biofeedback Training and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Neuromuscular Disease, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Virtual Reality, Biofeedback
- Being tested
- Virtual Reality Training, Biofeedback Training, Conventional rehabilitation
- Keywords
- motivation, neuromuscular disease, duchenne muscular dystrophy, spinal Muscular Atrophy, virtual reality, biofeedback training
- Medical subject headings
- Neuromuscular Diseases, Muscular Dystrophy, Duchenne, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TrainingOther
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 TrainingOther
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 rehabilitationOther
Participants will receive a 12-week conventional rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 1 Minute
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Feb 2019
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Kurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merve Kurt, Dokuz Eylul University
- Investigators
- Tülay Tarsuslu Şimşek, Study director, Professor Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689660
- Sponsor's protocol ID
- Merve Kurt
- Status last verified
- Apr 2026
- First submitted
- 26 Sep 2018
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD may share when requested
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03689660
- Acronym / sponsor ID
- Merve Kurt
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merve KurtUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Training | Experimental | Other: Virtual Reality TrainingVirtual 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 | Experimental | Other: Biofeedback TrainingBiofeedback training will be applied during the 12 weeks. The training will consist of three sessions per week and 30 minutes per session. |
| Conventional Rehabilitation | Other | Other: Conventional rehabilitationParticipants 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality TrainingParticipants 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. | Other | Virtual Reality Training |
| Biofeedback Trainingbiofeedback 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 | Biofeedback Training |
| Conventional rehabilitationParticipants will receive a 12-week conventional rehabilitation program. | Other | Conventional Rehabilitation |
Primary outcome
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.
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.
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.
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).
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.
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.
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".
7 secondary outcomes
Pediatric Functional Reaching Test
Time frame: 1 Minute
Fall Frequency
Time frame: 1 Minute
Muscle Strength Test with Hand Held Dinamometer
Time frame: 20 minutes
Timed Up Go Test
Time frame: 2 Minutes
Stair Climb Test
Time frame: 2 Minutes
T-shirt Wear Remove Test
Time frame: 2 Minutes
Stand Up from Supine Position Test
Time frame: 1 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. The IPD may share when requested
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tülay Tarsuslu Şimşek study director
Professor Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Training, Biofeedback Training and Conventional rehabilitation in people with Neuromuscular Disease and Duchenne Muscular Dystrophy, run by Merve Kurt at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Motor Function Measure-32 (time frame: 30 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.