NCT02500433

Brief Summary

OBJECTIVE: To investigate whether VR videogames plus conventional therapy improves motor control compared with conventional therapy in children with cerebral palsy (CP). METHODS: Thirty participants with CP were included. A baseline (A0), a post-conventional intervention (A1), a post-experimental treatment (A2) and a two-month follow-up (A3) assessment were performed. Experimental intervention was based on videogames treatment (Kinect-Kbox360TM) added to their conventional physiotherapy. Motor and the process skills were evaluated by the Assessment of Motor and Process Skills (AMPS); balance by the Pediatric Reach test (PRT); gait speed by the 10-meters walk test (10MW); and running and jumping capacity by the Gross Motor Function Measure (GMFM).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

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 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

June 9, 2015

Last Update Submit

July 15, 2015

Conditions

Keywords

Cerebral palsychildrehabilitationvideo gamesvirtual reality.

Outcome Measures

Primary Outcomes (4)

  • Assessment of Motor and Process Skills (AMPS)

    Observational assessment used to measure the quality of a person's activities of daily living (ADL). The person performs each prioritized and self-chosen ADL task in a familiar environment and the way he or she usually does it. After completion of each AMPS task observation, the occupational therapist scores the person's quality of performance on each of 16 ADL motor and 20 ADL process items according to the standardized criteria in the AMPS manual. Each task performance observed is scored separately and each ADL skill is rated using a 4-point ordinal scale. Once the evaluation is complete, the therapist enters the raw scores for each ADL task observed into the AMPS software. The AMPS software is then used to perform many-facet Rasch analyses of the person's ordinal raw items scores and generate linear quality of ADL task performance measures.

    60 minutes

  • 10-meters walk test (10MW)

    participants positioned their toes behind the start line and were instructed to walk at their comfortable speed and continue down the corridor until told to stop. Timing began the moment the participant initiated a step and ended when the leading foot crossed the finish line.

    15 minutes

  • Pediatric Reach test (PRT)

    is a valid and reliable measure with potential for use with children. Children were instructed to lean forward with their arms, moving at their ankles only, as far as possible without lifting their heels off the ground, and to maintain that position for three seconds. The average in centimeters of the three arms reach trials was used.

    5 minutes

  • Gross Motor Function Measure (GMFM).

    The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with CP, is the standard outcome assessment tool for functional intervention in CP. For this paper, standing and gait, running and jumping scales were used.

    45 minutes

Study Arms (2)

Device: Kinect-Xbox360TM

EXPERIMENTAL

Based around a webcam-style add-on peripheral for the Xbox 360 console, it enables users to control and interact with the Xbox 360 without the need to touch a game controller, through a natural user interface using gestures and spoken commands. Participants were asked to practice 30 minutes per day, 2 days per week for 2 months, added to their conventional treatment. The games used were Kinect Sports ITM, Kinect Joy RideTM and Kinect Disneyland AdventuresTM and involved balance and trunk movements, general and visual-manual coordination and limb tasks. Each subject followed instructions on the screen with the help of his physiotherapist, with points awarded based on degree and speed of movement and level of difficulty. Participants were initially exposed to the games in an hour introductory session, 2 weeks before the study began. All the sessions were supervised by physiotherapist.

Other: Device: Kinect-Xbox 360TM

Conventional therapy

OTHER

Conventional therapy was based on neurodevelopment treatment, psychomotor activities and kinesiotherapy during one month, twice per week, with 30 minutes per session. The treatment includes: active and passive kinesitherapy, muscle and tendons stretching, training of gait and deambulation, such as coordination and handling.

Other: Conventional therapy

Interventions

Based around a webcam-style add-on peripheral for the Xbox 360 console, it enables users to control and interact with the Xbox 360 without the need to touch a game controller, through a natural user interface using gestures and spoken commands. Participants were asked to practice 30 minutes per day, 2 days per week for 2 months, added to their conventional treatment. The games used were Kinect Sports ITM, Kinect Joy RideTM and Kinect Disneyland AdventuresTM and involved balance and trunk movements, general and visual-manual coordination and limb tasks. Each subject followed instructions on the screen with the help of his physiotherapist, with points awarded based on degree and speed of movement and level of difficulty.

Device: Kinect-Xbox360TM
Conventional therapy

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnostic of mild-moderate hemiplegic.
  • Diplegic cerebral palsy.
  • Age between four to eleven years.
  • Receive physiotherapy treatment in the public.
  • School related with this project

You may not qualify if:

  • Not Have Visual Impairments.
  • Severe Cognitive Disability.
  • Surgical Intervention In The Year Before Study Onset.
  • Botulinum Injections In The Six Months Before Study Onset.
  • Non-Controlled Epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Laura Luna, PhD

    Universidad Rey Juna Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 9, 2015

First Posted

July 16, 2015

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

July 16, 2015

Record last verified: 2015-07