Back to results

Effects of Virtual Reality on Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Virtual Reality with Kinect

Conventional Occupational Therapy (COT)

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VR group

Control group

Arm Description

Enrolled into 12 week VR intervention with Microsoft Kinect (twice a week, for 45 minutes) and conventional occupational therapy.

Control group only received conventional occupational therapy for 12 weeks

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04768374

First Posted

February 20, 2021

Last Updated

February 22, 2021

Sponsor

Hacettepe University

Collaborators

Uskudar University

1. Study Identification

Unique Protocol Identification Number

NCT04768374

Brief Title

Effects of Virtual Reality on Cerebral Palsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 5, 2020 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

Collaborators

Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VR group

Arm Type

Experimental

Arm Description

Enrolled into 12 week VR intervention with Microsoft Kinect (twice a week, for 45 minutes) and conventional occupational therapy.

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Control group only received conventional occupational therapy for 12 weeks

Intervention Type

Other

Intervention Name(s)

Virtual Reality with Kinect

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Conventional Occupational Therapy (COT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Independence in Activities of Daily living (assessed with Abilhand-kids)

Description

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

Time Frame

Baseline, 12th week (end of intervention), 24th and 36th week(follow up)

Title

Change in motor proficiency( assessed with Bruninsk-Oseretsky Test of Motor Proficiency 2-Brief Form (BOT2-BF))

Description

BOT2-BF is a test that evaluates motor proficiency and allows therapists to compare results with specified norm values

Time Frame

Baseline, 12th week (end of intervention), 24th and 36th week(follow up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Hacettepe University

City

Ankara

State/Province

Altındağ

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Virtual Reality on Cerebral Palsy

We'll reach out to this number within 24 hrs