- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01901211
Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy
CP Fit 'n' Fun Project: Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4G1R8
- Holland Bloorview Kids Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Exergaming
In this arm, the participants will participate in the exergaming intervention.
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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.
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NO_INTERVENTION: Comparison Arm
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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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.
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Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
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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)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
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)
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Handheld dynamometry will be used to measure muscle strength for the quadriceps muscles and the hamstrings at 90˚ of knee flexion in both legs. The individual sits with legs at 90˚ of knee flexion and resistance will be given anteriorly (knee extensors) and posteriorly (knee flexors) two inches proximal to the lateral malleoli. Higher score indicates greater strength. |
Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
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The 30-second Wingate Cycle Test
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)
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The 30-second Wingate Cycle Test is a measure of anaerobic power, a key component of physical fitness. The cycle test is performed when a participant uses a cycle ergometer and pedals as hard as they can for 30-seconds against a constant braking force. The measure is relative peak power (watts/kg) normalized to body weight. Higher scores indicate greater anaerobic power. |
Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
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Anthropometric Measurements
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)
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Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, will be used to assess body composition as indicators of physical fitness.
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Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
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Total Score of the KINDL-R 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)
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The total score of the 24-item KINDL-R questionnaire will measure the participants' health-related quality of life. Scores are on a five-point Likert scale that can be scored in isolation and is converted to percent of total score. Total score is the summed score divided by the total possible score. Full range of possible scores 0-120. Score is converted to percent of total subscale score (0-100%). Higher scores indicate greater health related quality of life. |
Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
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The Self-Worth Domain of the KINDL-R 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)
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The 4-item Self-worth Domain of the KINDL-R will be used as an indicator of self-esteem. 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 self-worth. |
Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
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Gaming Data
Time Frame: 10-weeks of the exergaming intervention
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Gaming data will be collected as measures of effectiveness of the games' balancing techniques, engagement and adherence. The games will be instrumented to automatically collect usage data including: amount of time playing; amount of time within HR zones while playing. Higher numbers indicate more activity and more time above 40% hear rate reserve (HRR) while playing. |
10-weeks of the exergaming intervention
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StepWatch Activity Monitors
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)
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StepWatch Activity Monitors will be used to measure activity levels and motor participation.
The StepWatch is a two-plane accelerometer that is worn around the ankle in a knit cuff.
The StepWatch measures ambulatory activity (i.e. total daily step count) and acts as an indicator of motor participation in the community.
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Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
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Anthropometric Measurements (Weight)
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)
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Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, and weight will be used to assess body composition as indicators of physical fitness.
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Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
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Collaborators and Investigators
Investigators
- Principal Investigator: Darcy Fehlings, MD, MSc, FRCPC, Holland Bloorview Kids Rehabilitation Hospital
- Principal Investigator: T.C. Nicholas Graham, PhD, Queen's University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-423
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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