Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exergaming Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Interactive computer play, Multi-player gaming, Exercise
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
Sites / Locations
- Holland Bloorview Kids Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exergaming
Comparison Arm
Arm Description
In this arm, the participants will participate in the exergaming 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
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.
The 30-second Wingate Cycle Test
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.
Anthropometric Measurements
Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, will be used to assess body composition as indicators of physical fitness.
Total Score of the KINDL-R Questionnaire
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.
The Self-Worth Domain of the KINDL-R Questionnaire
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.
Gaming Data
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.
StepWatch Activity Monitors
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.
Anthropometric Measurements (Weight)
Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, and weight will be used to assess body composition as indicators of physical fitness.
Full Information
NCT ID
NCT01901211
First Posted
July 11, 2013
Last Updated
December 6, 2018
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
Queen's University, Natural Sciences and Engineering Research Council, Canada
1. Study Identification
Unique Protocol Identification Number
NCT01901211
Brief Title
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
April 5, 2014 (Actual)
Study Completion Date
April 5, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborators
Queen's University, Natural Sciences and Engineering Research Council, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Interactive computer play, Multi-player gaming, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exergaming
Arm Type
Experimental
Arm Description
In this arm, the participants will participate in the exergaming intervention.
Arm Title
Comparison Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exergaming Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)
Description
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.
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)
Title
Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire
Description
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.
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)
Secondary Outcome Measure Information:
Title
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
Description
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.
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)
Title
The 30-second Wingate Cycle Test
Description
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.
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)
Title
Anthropometric Measurements
Description
Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, will be used to assess body composition as indicators of physical fitness.
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)
Title
Total Score of the KINDL-R Questionnaire
Description
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.
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)
Title
The Self-Worth Domain of the KINDL-R Questionnaire
Description
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.
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)
Title
Gaming Data
Description
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.
Time Frame
10-weeks of the exergaming intervention
Title
StepWatch Activity Monitors
Description
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.
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)
Title
Anthropometric Measurements (Weight)
Description
Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, and weight will be used to assess body composition as indicators of physical fitness.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darcy Fehlings, MD, MSc, FRCPC
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
T.C. Nicholas Graham, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G1R8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy
We'll reach out to this number within 24 hrs