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

NCT ID: NCT03689660

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuromuscular Disease Duchenne Muscular Dystrophy Spinal Muscular Atrophy Virtual Reality Biofeedback

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Nope

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Virtual Reality Training

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Biofeedback Training

Intervention Type OTHER

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 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.

Group Type OTHER

Conventional rehabilitation

Intervention Type OTHER

Participants will receive a 12-week conventional rehabilitation program.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Conventional rehabilitation

Participants will receive a 12-week conventional rehabilitation program.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merve Kurt

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Merve Kurt

Research Assistant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tülay Tarsuslu Şimşek

Role: STUDY_DIRECTOR

Professor Dr.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dokuz Eylul University

Izmir, Balcova, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Merve Kurt

Role: CONTACT

5537241324 ext. +90

Tülay Tarsuslu Şimşek

Role: CONTACT

2324124923

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tülay Tarsuslu Simsek, Prof.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Merve Kurt

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Reality in Chronic Neck Pain
NCT06549166 NOT_YET_RECRUITING NA