NCT04768374

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 20, 2021

Last Update Submit

February 22, 2021

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (2)

VR group

EXPERIMENTAL

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

Other: Virtual Reality with KinectOther: Conventional Occupational Therapy (COT)

Control group

ACTIVE COMPARATOR

Control group only received conventional occupational therapy for 12 weeks

Other: Conventional Occupational Therapy (COT)

Interventions

Virtual Reality with KinectOTHER

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.

VR group
Conventional Occupational Therapy (COT)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 groupVR group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

February 20, 2021

First Posted

February 24, 2021

Study Start

January 5, 2020

Primary Completion

March 15, 2020

Study Completion

March 20, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)