NCT01901211

Brief Summary

As children with cerebral palsy (CP) become teenagers, they experience a decrease in their physical function and mobility. Decreased mobility leads to increased social isolation for the teens and impacts negatively on their quality of life. This loss of function is multifactorial, but poor physical fitness and muscle weakness secondary to disuse are significant contributors. Exercise video games are a novel approach to engage youth in physical exercise and social interaction with their peers. The objective of this study is to evaluate the impact of an exercise video gaming intervention to improve physical fitness and social wellbeing. Our over-arching research questions are whether "exergames" can provide health benefits (improved physical fitness) and improved social wellbeing in youth with CP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

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

First Submitted

Initial submission to the registry

July 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 17, 2017

Completed
Last Updated

January 2, 2019

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

July 11, 2013

Results QC Date

January 31, 2017

Last Update Submit

December 6, 2018

Conditions

Cerebral Palsy

Keywords

Cerebral palsyInteractive computer playMulti-player gamingExercise

Outcome Measures

Primary Outcomes (2)

  • Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)

    The 7.5m Shuttle Run test (SRT-III) is a maximal, running-based, field test that can assess cardiovascular fitness in children with CP GMFCS level III. In the tests, markers are placed 7.5m apart in a square formation. Participants walk from marker to marker according to progressively faster auditory cues from a music device. The assessment is scored by the total number of shuttle run levels that the participant completes to the nearest half shuttle. A higher score is better.

    Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)

  • Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire

    Wellbeing Related to Friends/Peers domain of the KINDL-R is a four-item subscale focusing on time spent with friends, being perceived as a success with friends, getting along with friends and whether or not they felt different from peers over the past week. The subscale has 4 items scored on a five-point Likert scale that can be scored in isolation and is converted to percent of total subscale score. Full range of possible scores 0-20. Score is converted to percent of total subscale score (0-100%). Higher scores indicate greater social wellbeing.

    Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)

Secondary Outcomes (8)

  • Handheld Dynamometry Measures of Knee Flexors and Knee Extensors

    Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)

  • The 30-second Wingate Cycle Test

    Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)

  • Anthropometric Measurements

    Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)

  • Total Score of the KINDL-R Questionnaire

    Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)

  • The Self-Worth Domain of the KINDL-R Questionnaire

    Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)

  • +3 more secondary outcomes

Study Arms (2)

Exergaming

EXPERIMENTAL

In this arm, the participants will participate in the exergaming intervention.

Other: Exergaming Intervention

Comparison Arm

NO INTERVENTION

In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week.

Interventions

Exergaming InterventionOTHER

The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues.

Exergaming

Eligibility Criteria

Age9 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of CP and GMFCS level III
  • Between 9 and 18 years of age inclusive
  • Ability to operate a handheld videogame controller
  • High-speed internet in the home
  • Able to commit for the entire study duration

You may not qualify if:

  • Orthopedic surgery in the preceding six months
  • Exercise-induced asthma
  • Any underlying heart condition
  • Seizure disorder
  • Visual, auditory or cognitive disabilities that will interfere with game play

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Results Point of Contact

Title
Darcy Fehlings, MD, MSc, FRCP(C)
Organization
Holland Bloorview Kids Rehabilitation Hospital
dfehlings@hollandbloorview.ca
416-425-6220

Study Officials

  • Darcy Fehlings, MD, MSc, FRCPC

    Holland Bloorview Kids Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

  • T.C. Nicholas Graham, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 17, 2013

Study Start

September 1, 2013

Primary Completion

April 5, 2014

Study Completion

April 5, 2014

Last Updated

January 2, 2019

Results First Posted

March 17, 2017

Record last verified: 2016-01

Locations

CA(1)