An interventional study of Exergaming Intervention in Cerebral Palsy, sponsored by Holland Bloorview Kids Rehabilitation Hospital. Completed at 1 site in Canada. Open to participants aged 9 Years to 19 Years. Per ClinicalTrials.gov, last updated 2019-01-02.
Sponsored by Holland Bloorview Kids Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
In this arm, the participants will participate in the exergaming intervention.
Other: 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.
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.
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.
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)
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.
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)
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.
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 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.
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)
Anthropometric Measurements
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)
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.
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 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.
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)
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.
Time frame: 10-weeks of the exergaming intervention
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.
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)
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.
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)
| Milestone | Exergaming First, Then Comparison | Comparison First, Then Exergaming |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
| Milestone | Exergaming First, Then Comparison | Comparison First, Then Exergaming |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
| Milestone | Exergaming First, Then Comparison | Comparison First, Then Exergaming |
|---|---|---|
| Started | 6 | 5 |
| Completed | 6 | 5 |
| Not completed | 0 | 0 |
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.
| units on a scale | Exergaming | Comparison Arm |
|---|---|---|
| SRT at baseline | 8.3 ± 7.2 | 8.6 ± 6.4 |
| SRT change from baseline | 1.1 ± 1.7 | 0.7 ± 2.6 |
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.
| percentage of total subscale score | Exergaming | Comparison Arm |
|---|---|---|
| Social Wellbeing Domain of the KINDL-R at baseline | 63.1 ± 26 | 79.4 ± 23.1 |
| Social Wellbeing Domain of the KINDL-R change | 14.4 ± 25.3 | -5.6 ± 24.1 |
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.
| pounds | Exergaming | Comparison Arm |
|---|---|---|
| Quad-Left at baseline | 12.1 ± 6.1 | 11.5 ± 4.6 |
| Quad-Left change from baseline | -0.1 ± 5.4 | 0.1 ± 3.5 |
| Quad-Right at baseline | 11.5 ± 4.4 | 11.5 ± 4.4 |
| Quad-Change change from baseline | -0.8 ± 4.4 | 0.1 ± 3.2 |
| Hamstring-Left at baseline | 4.9 ± 4.4 | 5.2 ± 4.0 |
| Hamstring-Left change from baseline | 0.5 ± 2 | 1.3 ± 1.5 |
| Hamstring-Right at baseline | 5.5 ± 3.8 | 5.3 ± 3.8 |
| Hamstring-Right change from baseline | 0.2 ± 2.7 | 0.8 ± 2.0 |
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.
| Watts/Kg | Exergaming | Comparison Arm |
|---|---|---|
| Relative peak power baseline | 1.92 ± 1.54 | 2.49 ± 1.41 |
| Relative peak power change | 0.26 ± 1.0 | -0.01 ± 1.43 |
Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, will be used to assess body composition as indicators of physical fitness.
| cm | Exergaming | Comparison Arm |
|---|---|---|
| Waist circumference at baseline | 83.2 ± 14.4 | 80.1 ± 14.4 |
| waist circumference change from baseline | -1.2 ± 1.6 | 2.5 ± 2.5 |
| Tricep skinfold thickness at baseline | 2.67 ± 10.52 | 15.60 ± 8.13 |
| Tricep skinfold thickness change from baseline | -0.93 ± 4.70 | 0.85 ± 5.04 |
| Subscap skinfold thickness at baseline | 13.67 ± 5.77 | 11.87 ± 14.40 |
| Subscap skinfold thickness change from baseline | 2.08 ± 2.08 | 6.90 ± 12.97 |
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.
| percentage of total score on a scale | Exergaming | Comparison Arm |
|---|---|---|
| Total Score of the KINDL-R at baseline | 68.3 ± 8.1 | 73.3 ± 14.2 |
| Total Score of the KINDL-R change from baseline | 2 ± 12.8 | -7.4 ± 17.1 |
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.
| percentage of total subscale score | Exergaming | Comparison Arm |
|---|---|---|
| KINDL-R at baseline | 69.4 ± 19.5 | 77.5 ± 19.4 |
| KINDL-R change from baseline | 3.1 ± 21.5 | -10.6 ± 26.5 |
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.
| minutes | Exergaming |
|---|---|
| Minutes above 40% Heart Rate Reserve per day | 14.7 ± 8.8 |
| Minutes of activity from exergame per day | 35.4 ± 10.9 |
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.
| Steps/day | Exergaming | Comparison Arm |
|---|---|---|
| StepWatch Activity at baseline | 77.5 ± 69.5 | 86.1 ± 96.4 |
| StepWatch Activity change from baseline | 21.3 ± 55.2 | -21.0 ± 63.3 |
Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, and weight will be used to assess body composition as indicators of physical fitness.
| Kg | Exergaming | Comparison Arm |
|---|---|---|
| Weight at baseline | 52.2 ± 23.4 | 47.2 ± 14.4 |
| Weight change from baseline | -2.5 ± 17.5 | 0.8 ± 5.7 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exergaming | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) |
| Comparison Arm | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) |
| Event | Exergaming | Comparison Arm |
|---|---|---|
| lower back painMusculoskeletal and connective tissue disorders | 1/11 | 1/11 |
| Muscle sorenessMusculoskeletal and connective tissue disorders | 0/11 | 1/11 |
| muscle sorenessMusculoskeletal and connective tissue disorders | 0/11 | 1/11 |
| DiscomfortProduct Issues | 0/11 | 1/11 |
| Age, Categorical(Participants) | Exergaming First, Then Comparison | Comparison First, Then Exergaming | Total |
|---|---|---|---|
| <=18 years | 6 | 4 | 10 |
| Between 18 and 65 years | 0 | 1 | 1 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Exergaming First, Then Comparison | Comparison First, Then Exergaming | Total |
|---|---|---|---|
| Mean | 14.5 ± 1.3 | 16.0 ± 2.4 | 15.2 ± 2.0 |
| Sex: Female, Male(Participants) | Exergaming First, Then Comparison | Comparison First, Then Exergaming | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 4 | 4 | 8 |
| Race and Ethnicity Not Collected(Participants) | Exergaming First, Then Comparison | Comparison First, Then Exergaming | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Exergaming First, Then Comparison | Comparison First, Then Exergaming | Total |
|---|---|---|---|
| Canada | 6 | 5 | 11 |
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Holland Bloorview Kids Rehabilitation Hospital