Clinical trial NCT03689660: 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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Motor Function Measure-32
timeFrame: 30 minutes
measure: Pediatric Functional Independence Measure
timeFrame: 5 minutes
measure: Balance Master System
timeFrame: 20 minutes
measure: Vignos Scale
timeFrame: 2 Minutes
measure: Feasibility of Virtual Reality
timeFrame: 1 Minutes
measure: Pediatric Motivation Scale
timeFrame: 5 Minutes
measure: Visual Analog Scale
timeFrame: 1 Minute
Secondary outcomes:
measure: Pediatric Functional Reaching Test
timeFrame: 1 Minute
measure: Fall Frequency
timeFrame: 1 Minute
measure: Muscle Strength Test with Hand Held Dinamometer
timeFrame: 20 minutes
measure: Timed Up Go Test
timeFrame: 2 Minutes
measure: Stair Climb Test
timeFrame: 2 Minutes
measure: T-shirt Wear Remove Test
timeFrame: 2 Minutes
measure: Stand Up from Supine Position Test
timeFrame: 1 Minutes
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
state: Balcova
Study officials:
affiliation: Professor Dr.
name: Tülay Tarsuslu Şimşek
role: STUDY_DIRECTOR
References: