Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689660
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Merve Kurt, Dokuz Eylul University

Tracking Information
First Submitted Date  ICMJE September 26, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date January 23, 2019
Estimated Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • 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.
  • Biodex Balance System [ Time Frame: 20 minutes ]
    The Biodex Balance System SD allows clinicians to assess a patient's neuromuscular control in a closed-chain, multi-plane test by quantifying the ability of the patient to maintain dynamic unilateral or bilateral postural stability on either a static or unstable surface. With this system, General Stability Index (GSI), Antero-posterior Stability Index (APSI) and Mediolateral Stability Index (MLSI) can be evaluated.
  • 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".
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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.
  • Biodex Balance System [ Time Frame: 20 minutes ]
    The Biodex Balance System SD allows clinicians to assess a patient's neuromuscular control in a closed-chain, multi-plane test by quantifying the ability of the patient to maintain dynamic unilateral or bilateral postural stability on either a static or unstable surface. With this system, General Stability Index (GSI), Antero-posterior Stability Index (APSI) and Mediolateral Stability Index (MLSI) can be evaluated.
  • 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).
  • Laboratory Tests [ Time Frame: 1 Minutes ]
    Creatine Kinase, Lactate Dehydrogenase (LDH), Myoglobin, Serum Electrolytes, C-Reactive Protein levels will be evaluated. 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".
Change History Complete list of historical versions of study NCT03689660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Pediatric Functional Reaching Test [ Time Frame: 1 Minute ]
    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 [ Time Frame: 1 Minute ]
    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 [ Time Frame: 20 minutes ]
    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 [ Time Frame: 2 Minutes ]
    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 [ Time Frame: 2 Minutes ]
    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 [ Time Frame: 2 Minutes ]
    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 [ Time Frame: 1 Minutes ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Virtual Reality in Children With Neuromuscular Disease, Effectiveness of Virtual Reality and Biofeedback
Official Title  ICMJE 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
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:

  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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Nope
Primary Purpose: Treatment
Condition  ICMJE
  • Neuromuscular Disease
  • Duchenne Muscular Dystrophy
  • Spinal Muscular Atrophy
  • Virtual Reality
  • Biofeedback
Intervention  ICMJE
  • 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.
  • 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 receive a 12-week conventional rehabilitation program.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Virtual Reality Training
  • 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.
    Intervention: Other: Biofeedback Training
  • 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.
    Intervention: Other: Conventional rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Merve Kurt 5537241324 ext +90 merveekurtt93@gmail.com
Contact: Tülay Tarsuslu Şimşek 2324124923 tulay_tarsuslu@yahoo.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689660
Other Study ID Numbers  ICMJE Merve Kurt
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Merve Kurt, Dokuz Eylul University
Study Sponsor  ICMJE Merve Kurt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tülay Tarsuslu Şimşek Professor Dr.
PRS Account Dokuz Eylul University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP