Effects of Virtual Reality on Cerebral Palsy

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Virtual Reality with Kinect; Other: Conventional Occupational Therapy (COT)

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altındağ
    • Ankara, Altındağ, Turkey
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VR group; Enrolled into 12 week VR intervention with Microsoft Kinect (twice a week, for 45 minutes) and conventional occupational therapy.	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.; Other: 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.
ACTIVE_COMPARATOR: Control group; Control group only received conventional occupational therapy for 12 weeks	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Hacettepe University
• Collaborators: Uskudar University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2020
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): March 20, 2020

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (ACTUAL): February 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 61351342/ 2020- 214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No