Effects of Virtual Reality on Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Effects of Virtual Reality on Cerebral Palsy; A Single-blind, Randomized Control Study: 3 Months Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768374
• Other study ID #: 61351342/ 2020- 214
• Status: Completed
• Phase: N/A
• Start date: January 5, 2020
• Est. completion date: March 20, 2020

Study information

• Verified date: February 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Virtual reality (VR), is one of the most popular approaches to Cerebral Palsy (CP) rehabilitation and has been used in rehabilitation field for 30 years. VR is provided via a computer or a game console, and players interact with real-like objects . Using a VR interface as a rehabilitation tool increases the fun received by the client which, in turn, increases the participation of the client to the rehabilitation sessions.

This is a study that focused on long-term effects of Virtual reality (VR) intervention on motor skills and activities of daily living (ADL) independence of children with CP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 20, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• had to be 7 to 12 years-old,

• to be diagnosed with CP,

• to get 1 or 2 from Gross Motor Functioning Classification System,

• to get a score of 1 to 3 from Manual Ability Classification System,

• to score at least 23 from Mini Mental State Examination - children edition,

• to be able to follow verbal instructions, and

• to have the

Exclusion Criteria:

• having any surgical operation and/or botulinum toxin injection in last 6 months,

• having any visual and hearing diseases that may affect using VR, and

• participating in any other rehabilitation programs (such as physiotherapy, speech therapy, psychotherapy etc.),

• having ataxic and/or dyskinetic symptoms.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Virtual Reality with Kinect
In the study it was conducted a 12 week-intensive VR intervention (twice a week, 45 minutes each) and compared the results in the 12th week to investigate the effects of rehabilitation and follow-up assessments were made in the 16th and 24th weeks. From the beginning of the VR intervention, each game was played in equal durations by each participant. However, the difficulty of the games varied depending on the child's performance. Microsoft Kinect Games-Carnival Games was used as VR intervention. In meeting held with the authors to determine which games would be used in the VR program, 5 games were chosen and the remaining games were removed from the program because of their similar contents.
• Conventional Occupational Therapy (COT)
The COT based on neurodevelopmental treatment was carried out by the same occupational therapist. The treatment goals aimed at increasing the use of participant's extremities and improving the independence in ADL. The activities in the treatment were chosen in view of children's motor skills and daily living activities such as getting dressed, solving puzzles, and writing etc. Both groups received COT while the control group received COT only for 12 weeks.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Altindag

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Uskudar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Independence in Activities of Daily living (assessed with Abilhand-kids)	ABILHAND-Kids is a scale that was developed to evaluate activities of daily living (ADL) requiring upper limb usage of children aged between 6-15 years	Baseline, 12th week (end of intervention), 24th and 36th week(follow up)
Primary	Change in motor proficiency( assessed with Bruninsk-Oseretsky Test of Motor Proficiency 2-Brief Form (BOT2-BF))	BOT2-BF is a test that evaluates motor proficiency and allows therapists to compare results with specified norm values	Baseline, 12th week (end of intervention), 24th and 36th week(follow up)