Trial Outcomes & Findings for Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy (NCT NCT01901211)
NCT ID: NCT01901211
Last Updated: 2019-01-02
Results Overview
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.
COMPLETED
NA
11 participants
Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)
2019-01-02
Participant Flow
Participant milestones
| Measure |
Exergaming First, Then Comparison
In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.
Exergaming Intervention: 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.
|
Comparison First, Then Exergaming
In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.
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.
|
|---|---|---|
|
First Ten-week Period
STARTED
|
6
|
5
|
|
First Ten-week Period
COMPLETED
|
6
|
5
|
|
First Ten-week Period
NOT COMPLETED
|
0
|
0
|
|
Washout (6 Weeks)
STARTED
|
6
|
5
|
|
Washout (6 Weeks)
COMPLETED
|
6
|
5
|
|
Washout (6 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Ten-week Period
STARTED
|
6
|
5
|
|
Second Ten-week Period
COMPLETED
|
6
|
5
|
|
Second Ten-week Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exergaming First, Then Comparison
n=6 Participants
In this arm, the participants will participate in the exergaming intervention during the first ten-week then after 6-week washout, will participate in the comparison activities during the second ten-week period.
Exergaming Intervention: 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.
|
Comparison First, Then Exergaming
n=5 Participants
In this arm of the study, participants will complete comparison activities during the first ten-week then after 6-week washout, will participate in the exergaming intervention during the second ten-week period.
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.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 1.3 • n=6 Participants
|
16.0 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
15.2 years
STANDARD_DEVIATION 2.0 • n=11 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
6 participants
n=6 Participants
|
5 participants
n=5 Participants
|
11 participants
n=11 Participants
|
PRIMARY outcome
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)Population: One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.
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.
Outcome measures
| Measure |
Exergaming
n=10 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
n=11 Participants
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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.
|
|---|---|---|
|
Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)
SRT at baseline
|
8.3 units on a scale
Standard Deviation 7.2
|
8.6 units on a scale
Standard Deviation 6.4
|
|
Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)
SRT change from baseline
|
1.1 units on a scale
Standard Deviation 1.7
|
0.7 units on a scale
Standard Deviation 2.6
|
PRIMARY outcome
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)Population: One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.
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.
Outcome measures
| Measure |
Exergaming
n=10 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
n=11 Participants
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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.
|
|---|---|---|
|
Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire
Social Wellbeing Domain of the KINDL-R at baseline
|
63.1 percentage of total subscale score
Standard Deviation 26
|
79.4 percentage of total subscale score
Standard Deviation 23.1
|
|
Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire
Social Wellbeing Domain of the KINDL-R change
|
14.4 percentage of total subscale score
Standard Deviation 25.3
|
-5.6 percentage of total subscale score
Standard Deviation 24.1
|
SECONDARY outcome
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)Population: One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.
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.
Outcome measures
| Measure |
Exergaming
n=10 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
n=11 Participants
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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.
|
|---|---|---|
|
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
Quad-Left at baseline
|
12.1 pounds
Standard Deviation 6.1
|
11.5 pounds
Standard Deviation 4.6
|
|
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
Quad-Left change from baseline
|
-0.1 pounds
Standard Deviation 5.4
|
0.1 pounds
Standard Deviation 3.5
|
|
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
Quad-Right at baseline
|
11.5 pounds
Standard Deviation 4.4
|
11.5 pounds
Standard Deviation 4.4
|
|
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
Quad-Change change from baseline
|
-0.8 pounds
Standard Deviation 4.4
|
0.1 pounds
Standard Deviation 3.2
|
|
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
Hamstring-Left at baseline
|
4.9 pounds
Standard Deviation 4.4
|
5.2 pounds
Standard Deviation 4.0
|
|
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
Hamstring-Left change from baseline
|
0.5 pounds
Standard Deviation 2
|
1.3 pounds
Standard Deviation 1.5
|
|
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
Hamstring-Right at baseline
|
5.5 pounds
Standard Deviation 3.8
|
5.3 pounds
Standard Deviation 3.8
|
|
Handheld Dynamometry Measures of Knee Flexors and Knee Extensors
Hamstring-Right change from baseline
|
0.2 pounds
Standard Deviation 2.7
|
0.8 pounds
Standard Deviation 2.0
|
SECONDARY outcome
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)Population: This test was unsuitable for over half the participants, who were unable to complete one or more of the 30-second Wingate tests. Malfunctioning equipment also made collecting full data sets impossible.
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.
Outcome measures
| Measure |
Exergaming
n=5 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
n=5 Participants
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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 30-second Wingate Cycle Test
Relative peak power change
|
0.26 Watts/Kg
Standard Deviation 1.0
|
-0.01 Watts/Kg
Standard Deviation 1.43
|
|
The 30-second Wingate Cycle Test
Relative peak power baseline
|
1.92 Watts/Kg
Standard Deviation 1.54
|
2.49 Watts/Kg
Standard Deviation 1.41
|
SECONDARY outcome
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)Population: One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.
Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, will be used to assess body composition as indicators of physical fitness.
Outcome measures
| Measure |
Exergaming
n=10 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
n=11 Participants
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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.
|
|---|---|---|
|
Anthropometric Measurements
Waist circumference at baseline
|
83.2 cm
Standard Deviation 14.4
|
80.1 cm
Standard Deviation 14.4
|
|
Anthropometric Measurements
waist circumference change from baseline
|
-1.2 cm
Standard Deviation 1.6
|
2.5 cm
Standard Deviation 2.5
|
|
Anthropometric Measurements
Tricep skinfold thickness at baseline
|
2.67 cm
Standard Deviation 10.52
|
15.60 cm
Standard Deviation 8.13
|
|
Anthropometric Measurements
Tricep skinfold thickness change from baseline
|
-0.93 cm
Standard Deviation 4.70
|
0.85 cm
Standard Deviation 5.04
|
|
Anthropometric Measurements
Subscap skinfold thickness at baseline
|
13.67 cm
Standard Deviation 5.77
|
11.87 cm
Standard Deviation 14.40
|
|
Anthropometric Measurements
Subscap skinfold thickness change from baseline
|
2.08 cm
Standard Deviation 2.08
|
6.90 cm
Standard Deviation 12.97
|
SECONDARY outcome
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)Population: One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.
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.
Outcome measures
| Measure |
Exergaming
n=10 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
n=11 Participants
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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.
|
|---|---|---|
|
Total Score of the KINDL-R Questionnaire
Total Score of the KINDL-R at baseline
|
68.3 percentage of total score on a scale
Standard Deviation 8.1
|
73.3 percentage of total score on a scale
Standard Deviation 14.2
|
|
Total Score of the KINDL-R Questionnaire
Total Score of the KINDL-R change from baseline
|
2 percentage of total score on a scale
Standard Deviation 12.8
|
-7.4 percentage of total score on a scale
Standard Deviation 17.1
|
SECONDARY outcome
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)Population: One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.
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.
Outcome measures
| Measure |
Exergaming
n=10 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
n=11 Participants
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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 Self-Worth Domain of the KINDL-R Questionnaire
KINDL-R at baseline
|
69.4 percentage of total subscale score
Standard Deviation 19.5
|
77.5 percentage of total subscale score
Standard Deviation 19.4
|
|
The Self-Worth Domain of the KINDL-R Questionnaire
KINDL-R change from baseline
|
3.1 percentage of total subscale score
Standard Deviation 21.5
|
-10.6 percentage of total subscale score
Standard Deviation 26.5
|
SECONDARY outcome
Timeframe: 10-weeks of the exergaming interventionGaming 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.
Outcome measures
| Measure |
Exergaming
n=11 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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.
|
|---|---|---|
|
Gaming Data
Minutes above 40% Heart Rate Reserve per day
|
14.7 minutes
Standard Deviation 8.8
|
—
|
|
Gaming Data
Minutes of activity from exergame per day
|
35.4 minutes
Standard Deviation 10.9
|
—
|
SECONDARY outcome
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)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.
Outcome measures
| Measure |
Exergaming
n=10 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
n=10 Participants
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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.
|
|---|---|---|
|
StepWatch Activity Monitors
StepWatch Activity at baseline
|
77.5 Steps/day
Standard Deviation 69.5
|
86.1 Steps/day
Standard Deviation 96.4
|
|
StepWatch Activity Monitors
StepWatch Activity change from baseline
|
21.3 Steps/day
Standard Deviation 55.2
|
-21.0 Steps/day
Standard Deviation 63.3
|
SECONDARY outcome
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)Population: One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.
Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, and weight will be used to assess body composition as indicators of physical fitness.
Outcome measures
| Measure |
Exergaming
n=10 Participants
In this arm, the participants will participate in the exergaming intervention in either the first or the last part of the study.
Exergaming Intervention: 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.
|
Comparison Arm
n=11 Participants
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration in either the first or the last part of the study.
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.
|
|---|---|---|
|
Anthropometric Measurements (Weight)
Weight at baseline
|
52.2 Kg
Standard Deviation 23.4
|
47.2 Kg
Standard Deviation 14.4
|
|
Anthropometric Measurements (Weight)
Weight change from baseline
|
-2.5 Kg
Standard Deviation 17.5
|
0.8 Kg
Standard Deviation 5.7
|
Adverse Events
Exergaming
Comparison Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exergaming
n=11 participants at risk
In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.
Exergaming Intervention: 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.
|
Comparison Arm
n=11 participants at risk
In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle soreness
|
0.00%
0/11
|
9.1%
1/11 • Number of events 8
|
|
Product Issues
Discomfort
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
Additional Information
Darcy Fehlings, MD, MSc, FRCP(C)
Holland Bloorview Kids Rehabilitation Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place