Cerebral Palsy
Conditions
Keywords
Cerebral palsy, Interactive computer play, Multi-player gaming, Exercise
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.
Interventions
OTHERExergaming 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.
Sponsors
Queen's University
Natural Sciences and Engineering Research Council, Canada
Holland Bloorview Kids Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 19 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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 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 | 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 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. |
| 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) | 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. |
| 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) | 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) | 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 of waist circumference, triceps and subscapular skinfold thickness, and weight will be used to assess body composition as indicators of physical fitness. |
| Gaming Data | 10-weeks of the exergaming intervention | 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. |
| 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) | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exergaming First, Then Comparison 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. | 6 |
| Comparison First, Then Exergaming 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. | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Comparison First, Then Exergaming | Total | Exergaming First, Then Comparison |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 10 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Continuous | 16.0 years STANDARD_DEVIATION 2.4 | 15.2 years STANDARD_DEVIATION 2 | 14.5 years STANDARD_DEVIATION 1.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 5 participants | 11 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 1 / 11 | 2 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | 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 |
| Exergaming | 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 |
| Comparison Arm | Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III) | SRT at baseline | 8.6 units on a scale | Standard Deviation 6.4 |
| Comparison Arm | Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III) | SRT change from baseline | 0.7 units on a scale | Standard Deviation 2.6 |
Primary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | 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 |
| Exergaming | 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 |
| Comparison Arm | Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire | Social Wellbeing Domain of the KINDL-R at baseline | 79.4 percentage of total subscale score | Standard Deviation 23.1 |
| Comparison Arm | Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire | Social Wellbeing Domain of the KINDL-R change | -5.6 percentage of total subscale score | Standard Deviation 24.1 |
Secondary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | Anthropometric Measurements | waist circumference change from baseline | -1.2 cm | Standard Deviation 1.6 |
| Exergaming | Anthropometric Measurements | Tricep skinfold thickness change from baseline | -0.93 cm | Standard Deviation 4.7 |
| Exergaming | Anthropometric Measurements | Waist circumference at baseline | 83.2 cm | Standard Deviation 14.4 |
| Exergaming | Anthropometric Measurements | Subscap skinfold thickness at baseline | 13.67 cm | Standard Deviation 5.77 |
| Exergaming | Anthropometric Measurements | Tricep skinfold thickness at baseline | 2.67 cm | Standard Deviation 10.52 |
| Exergaming | Anthropometric Measurements | Subscap skinfold thickness change from baseline | 2.08 cm | Standard Deviation 2.08 |
| Comparison Arm | Anthropometric Measurements | Subscap skinfold thickness change from baseline | 6.90 cm | Standard Deviation 12.97 |
| Comparison Arm | Anthropometric Measurements | Waist circumference at baseline | 80.1 cm | Standard Deviation 14.4 |
| Comparison Arm | Anthropometric Measurements | waist circumference change from baseline | 2.5 cm | Standard Deviation 2.5 |
| Comparison Arm | Anthropometric Measurements | Tricep skinfold thickness at baseline | 15.60 cm | Standard Deviation 8.13 |
| Comparison Arm | Anthropometric Measurements | Tricep skinfold thickness change from baseline | 0.85 cm | Standard Deviation 5.04 |
| Comparison Arm | Anthropometric Measurements | Subscap skinfold thickness at baseline | 11.87 cm | Standard Deviation 14.4 |
Secondary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | Anthropometric Measurements (Weight) | Weight at baseline | 52.2 Kg | Standard Deviation 23.4 |
| Exergaming | Anthropometric Measurements (Weight) | Weight change from baseline | -2.5 Kg | Standard Deviation 17.5 |
| Comparison Arm | Anthropometric Measurements (Weight) | Weight at baseline | 47.2 Kg | Standard Deviation 14.4 |
| Comparison Arm | Anthropometric Measurements (Weight) | Weight change from baseline | 0.8 Kg | Standard Deviation 5.7 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | Gaming Data | Minutes above 40% Heart Rate Reserve per day | 14.7 minutes | Standard Deviation 8.8 |
| Exergaming | Gaming Data | Minutes of activity from exergame per day | 35.4 minutes | Standard Deviation 10.9 |
Secondary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Quad-Left at baseline | 12.1 pounds | Standard Deviation 6.1 |
| Exergaming | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Hamstring-Left at baseline | 4.9 pounds | Standard Deviation 4.4 |
| Exergaming | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Hamstring-Left change from baseline | 0.5 pounds | Standard Deviation 2 |
| Exergaming | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Quad-Right at baseline | 11.5 pounds | Standard Deviation 4.4 |
| Exergaming | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Hamstring-Right at baseline | 5.5 pounds | Standard Deviation 3.8 |
| Exergaming | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Quad-Left change from baseline | -0.1 pounds | Standard Deviation 5.4 |
| Exergaming | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Hamstring-Right change from baseline | 0.2 pounds | Standard Deviation 2.7 |
| Exergaming | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Quad-Change change from baseline | -0.8 pounds | Standard Deviation 4.4 |
| Comparison Arm | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Hamstring-Right change from baseline | 0.8 pounds | Standard Deviation 2 |
| Comparison Arm | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Quad-Left at baseline | 11.5 pounds | Standard Deviation 4.6 |
| Comparison Arm | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Quad-Left change from baseline | 0.1 pounds | Standard Deviation 3.5 |
| Comparison Arm | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Quad-Right at baseline | 11.5 pounds | Standard Deviation 4.4 |
| Comparison Arm | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Quad-Change change from baseline | 0.1 pounds | Standard Deviation 3.2 |
| Comparison Arm | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Hamstring-Left change from baseline | 1.3 pounds | Standard Deviation 1.5 |
| Comparison Arm | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Hamstring-Right at baseline | 5.3 pounds | Standard Deviation 3.8 |
| Comparison Arm | Handheld Dynamometry Measures of Knee Flexors and Knee Extensors | Hamstring-Left at baseline | 5.2 pounds | Standard Deviation 4 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | StepWatch Activity Monitors | StepWatch Activity at baseline | 77.5 Steps/day | Standard Deviation 69.5 |
| Exergaming | StepWatch Activity Monitors | StepWatch Activity change from baseline | 21.3 Steps/day | Standard Deviation 55.2 |
| Comparison Arm | StepWatch Activity Monitors | StepWatch Activity at baseline | 86.1 Steps/day | Standard Deviation 96.4 |
| Comparison Arm | StepWatch Activity Monitors | StepWatch Activity change from baseline | -21.0 Steps/day | Standard Deviation 63.3 |
Secondary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | The 30-second Wingate Cycle Test | Relative peak power baseline | 1.92 Watts/Kg | Standard Deviation 1.54 |
| Exergaming | The 30-second Wingate Cycle Test | Relative peak power change | 0.26 Watts/Kg | Standard Deviation 1 |
| Comparison Arm | The 30-second Wingate Cycle Test | Relative peak power baseline | 2.49 Watts/Kg | Standard Deviation 1.41 |
| Comparison Arm | The 30-second Wingate Cycle Test | Relative peak power change | -0.01 Watts/Kg | Standard Deviation 1.43 |
Secondary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | The Self-Worth Domain of the KINDL-R Questionnaire | KINDL-R at baseline | 69.4 percentage of total subscale score | Standard Deviation 19.5 |
| Exergaming | 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 |
| Comparison Arm | The Self-Worth Domain of the KINDL-R Questionnaire | KINDL-R at baseline | 77.5 percentage of total subscale score | Standard Deviation 19.4 |
| Comparison Arm | The Self-Worth Domain of the KINDL-R Questionnaire | KINDL-R change from baseline | -10.6 percentage of total subscale score | Standard Deviation 26.5 |
Secondary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exergaming | 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 |
| Exergaming | 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 |
| Comparison Arm | Total Score of the KINDL-R Questionnaire | Total Score of the KINDL-R at baseline | 73.3 percentage of total score on a scale | Standard Deviation 14.2 |
| Comparison Arm | Total Score of the KINDL-R Questionnaire | Total Score of the KINDL-R change from baseline | -7.4 percentage of total score on a scale | Standard Deviation 17.1 |