Clinical trial NCT01901211: Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy
Official title: CP Fit 'n' Fun Project: Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Interactive computer play
Multi-player gaming
Exercise
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Queen's University
name: Natural Sciences and Engineering Research Council, Canada
First posted: 2013-07-17
Enrollment: 11
Sex: ALL
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: The primary objectives of this study are to evaluate the impact of exergaming on cardiovascular fitness and social wellbeing related to friends/peers in youths with CP. The secondary objectives of the study will be to evaluate the impact of the exergaming intervention on additional components of physical fitness including anaerobic fitness, and muscle strength. In addition, the effect of the exergaming intervention on overall health-related quality of life (HRQL), self-esteem and motor participation will also be measured. Finally, the effectiveness of a technique for balancing performance in multiplayer exergames will be evaluated. The objectives will be investigated using a randomized crossover study design.Outcomes will be measured a total of four times: at study entry and after the first ten-week period (either comparison or intervention), at the end of a six-week washout period, then again after second period (either intervention or comparison). Outcomes will be assessed by physiotherapists and research staff members who will be blinded to the condition of the participants.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)
timeFrame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
measure: Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire
timeFrame: 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:
measure: Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
timeFrame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
measure: The 30-second Wingate Cycle Test
timeFrame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
measure: Anthropometric Measurements
timeFrame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
measure: Total Score of the KINDL-R Questionnaire
timeFrame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
measure: The Self-Worth Domain of the KINDL-R Questionnaire
timeFrame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
measure: Gaming Data
timeFrame: 10-weeks of the exergaming intervention
measure: StepWatch Activity Monitors
timeFrame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
measure: Anthropometric Measurements (Weight)
timeFrame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Darcy Fehlings, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University
name: T.C. Nicholas Graham, PhD
role: PRINCIPAL_INVESTIGATOR
References: