The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP
NCT ID: NCT06317935
Last Updated: 2024-03-19
Study Results
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.
NOT_YET_RECRUITING
NA
52 participants
INTERVENTIONAL
2024-04-23
2024-10-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The research is a randomized controlled, cross-over study. The sample group of the research is children diagnosed with hemiplegic cerebral palsy and families who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital.
Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.
The upper extremity functionality of both research groups before the intervention will be evaluated with the 'Motor Activity Diary for Children' scale and the perceived independence level with the 'Children's Hand Use Experience' scale.
After the initial evaluation is completed, group A, represented as the intervention group, will receive ArmeoSenso virtual reality intervention in the upper extremity hand function laboratory for 3 weeks, 5 days a week, each session for 30 minutes, in addition to traditional occupational therapy and physiotherapy rehabilitation programs. Meanwhile, group B, represented as the control group, will continue the traditional occupational therapy and physiotherapy rehabilitation program. At the end of the third week of the intervention, tests measuring upper extremity functionality and perceived independence level will be repeated.
Measurement tools will be repeated at the beginning of the intervention, at the end of the 3rd week, and at the end of the intervention.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Virtual Reality on Upper Extremity Function in Hemiplegic Cerebral Palsy
NCT02841319
Virtual Reality Mediated Upper Extremity rehabilitationPatients With Cerebral Palsy
NCT04529343
Individualized Virtual Reality in the Upper Extremity Rehabilitation of Hemiparetic Cerebral Palsy
NCT04630678
Role of Virtual Reality in Hand Rehabilitation for Children With Cerebral Palsy
NCT04954144
Effects of Action Observation Therapy and Video-Based Play Therapy on Children With Unilateral Cerebral Palsy
NCT05327179
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Statistical power analysis was performed to calculate the number of people required to be included in the study. Statistical power analysis was performed with G\*Power v.3.1.9.7 software. In the analysis, the Type 1 error margin (α) was accepted as 5% and the desired statistical power (1-β) was accepted as 0.80. In order to carry out the analysis, randomized controlled studies in the literature on the subject that reported effect sizes were examined. Studies have found that in virtual reality-based interventions applied to children with cerebral palsy, strong to very strong effect sizes were reported between intervention and control groups in variables such as upper extremity functions and performance in daily living activities (4, 7-11). When calculations were made using the strong effect size (Cohen's d = 0.80) in the sample size analysis, it was determined that the smallest sample size that needed to be reached for both groups was 26. Therefore, a total of 52 people were included in the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
Intervention group (A) will receive virtual reality application for 30 minutes, 5 days a week for 3 weeks, in addition to traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and will receive only traditional treatments between 3-6 weeks.
The control group (B) will receive only traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and between 3-6 weeks, they will receive virtual reality application in addition to traditional approaches for 30 minutes, 5 days a week for 3 weeks.
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ArmeoSenso
ArmeoSenso virtual reality application will be applied to group A in the 0-3 weeks of the study and to group B in the 3-6 weeks.
ArmeoSenso
ArmeoSenso is an upper extremity virtual reality application with three motion sensors and one hand grip sensor. The device detects the person's body, arm, forearm and hand movements and displays the reflection of the movements on the screen. The application includes studies on upper extremity functions.
Traditional Rehabilitation
It includes traditional occupational therapy and physiotherapy approaches.
Traditional rehabilitation
Traditional rehabilitation (physiotherapy and occupational therapy) approaches will continue to be applied to groups A and B at all stages of the research.
Traditional Rehabilitation
It includes traditional occupational therapy and physiotherapy approaches.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ArmeoSenso
ArmeoSenso is an upper extremity virtual reality application with three motion sensors and one hand grip sensor. The device detects the person's body, arm, forearm and hand movements and displays the reflection of the movements on the screen. The application includes studies on upper extremity functions.
Traditional Rehabilitation
It includes traditional occupational therapy and physiotherapy approaches.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Being between the ages of 6-12
* Not having any fixed contracture in the upper extremity
* According to the Modified Ashworth Scale, the upper extremity spasticity value is at the level of 1,1+,2 or 3
* Being at level I, II or III according to the Gross Motor Function Classification System (GMFCS)
* Being at level II or III according to the Manual Ability Classification System (MACS)
* Being at level I, II or III according to the Communication Function Classification System (CFCS)
* Being within the normal cognitive level according to the Modified Pediatrics Mini Mental Test score
* Being at level I, II or III according to the Eating and Drinking Ability Classification System (EDACS)
* Being at level I, II or III according to the Visual Function Classification System for Children with Cerabral Palsy (VFCS)
* Volunteering to participate in the study
Exclusion Criteria
* Having undergone a surgical procedure within the last 1 year
* Fracture, trauma, etc. in the upper extremity. to live
6 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ankara City Hospital Bilkent
OTHER
Hacettepe University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Basak Karadag
Occupational Therapist, PhD Student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Başak Karadağ, MSc
Role: PRINCIPAL_INVESTIGATOR
Ankara City Hospital Bilkent
Meral Huri, Professor
Role: STUDY_DIRECTOR
Hacettepe University
Berke Aras, Ass.Prof.
Role: PRINCIPAL_INVESTIGATOR
Ankara City Hospital Bilkent
Özge Tezen, MD
Role: STUDY_CHAIR
Ankara City Hospital Bilkent
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ankara Bilkent City Hospital
Multiple Locations, Ankara, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.
Goyal C, Vardhan V, Naqvi W. Virtual Reality-Based Intervention for Enhancing Upper Extremity Function in Children With Hemiplegic Cerebral Palsy: A Literature Review. Cureus. 2022 Jan 28;14(1):e21693. doi: 10.7759/cureus.21693. eCollection 2022 Jan.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HU-ERG-BK-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.