Effects of Virtual Reality on Cerebral Palsy

NCT ID: NCT04768374

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-05
• Study Completion Date: 2020-03-20

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR group

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

Group Type: EXPERIMENTAL

Virtual Reality with Kinect

Intervention Type: OTHER

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)

Intervention Type: OTHER

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.

Control group

Control group only received conventional occupational therapy for 12 weeks

Group Type: ACTIVE_COMPARATOR

Conventional Occupational Therapy (COT)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Orkun Tahir Aran

PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

61351342/ 2020- 214

Identifier Type: -

Identifier Source: org_study_id