CP Fit 'n' Fun Project: Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 9 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)
Time Frame: 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 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.
Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire
Time Frame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
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.
Secondary Outcomes
- 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))
- 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))
- Anthropometric Measurements (Weight)(Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2))
- 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))
- Gaming Data(10-weeks of the exergaming intervention)
- StepWatch Activity Monitors(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))