Cerebral Palsy, Conditions Similar to Cerebral Palsy
Conditions
Brief summary
Power wheelchairs offer children who are unable to independently opportunities for participation in social, educational, and leisure activities. Unfortunately, children who have severe cognitive, motor, or sensory impairments may need extended training to be able to master the power wheelchairs skills needed to qualify for their own power wheelchairs. The IndieTrainer system was developed to address this need. The IndieTrainer system is comprised of the IndieGo device and video-game modules. The IndieGo device temporarily converts a manual wheelchair into a powered wheelchair, thereby allowing children to remain in their own manual wheelchair and use their own custom seating system during power wheelchair skills training activities. The video-game modules are integrated into the IndieGo device such that the video games can be played on a television screen using the specific access method used to control the IndieGo (i.e., switch or joystick). The IndieTrainer system is designed to allow a child to practice power wheelchair skills as part of the video-game modules or as part of more traditional power wheelchair skills training activities wherein children are able to actively explore the environment and practice executing actual wheelchair skills. This study will evaluate the use of the IndieTrainer system in children with cerebral palsy, ages 3-21 years.
Interventions
OTHERIndieTrainer system
The IndieTrainer system is comprised of the IndieGo device and video-game modules. The IndieGo device temporarily converts a manual wheelchair into a powered wheelchair, thereby allowing children to remain in their own manual wheelchair and use their own custom seating system during power wheelchair skills training activities. The video-game modules are integrated into the IndieGo device such that the video games can be played on a TV screen using the specific access method used to control the IndieGo (i.e., switch or joystick). The IndieTrainer system is designed to allow a child to practice power wheelchair skills as part of the video-game modules or as part of more traditional power wheelchair skills training activities wherein children are able to actively explore the environment and practice executing actual wheelchair skills.
Sponsors
Grand Valley State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One group pretest-posttest design with a single session retention trial 4 weeks after the end of the intervention period.
Eligibility
Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Has a diagnosis of cerebral palsy or similar conditions with functional abilities consistent with a Gross Motor Classification System Classification System Level IV or Level V * Inability to functionally self-propel a manual wheelchair * Does not have an individually prescribed powered wheelchair * Currently using a manual wheelchair or adaptive stroller that can be safely used with the IndieTrainer system (i.e., functioning wheel brakes to remain locked onto platform, etc.) as assessed by the PI * Has at least one parent/caregiver who is able to converse in English (as assessed by the PI during interactions over the phone and in person) due to safety concerns
Exclusion criteria
* Any condition or issue that would prevent a child from safely using the IndieTrainer system as determined by the PI, a licensed physical therapist. * The child and his/her manual wheelchair or adaptive stroller combined must weigh \<300 pounds to safely use the IndieTrainer. * A diagnosis of a progressive condition with the potential for functional decline across the study period, such as spinal muscular atrophy, Duchenne muscular dystrophy, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child Participants' Understanding How to Use a Power Mobility Device Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3 | From baseline to immediately after the conclusion of the intervention period at Week 3 | This outcome will be assessed using each child participant's score (from a minimum of 1 to a maximal of 8) on the Assessment of Learning Powered mobility use. The Assessment of Learning Powered mobility use measures a child's understanding of how to use a power mobility device. Higher scores indicate a better outcome. |
| Change in Child Participants' Power Mobility Skill Performance Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3 | From baseline to immediately after the conclusion of the intervention period at Week 3 | This outcome will be assessed using the Wheelchair Skills Checklist that evaluates a child's performance of 7 items, each reflecting a specific power mobility skill. Each item is scored from a minimum of 0 to a maximum of 2 with a higher score indicating a better outcome. Total scores for all 7 items range from a minimum of 0 to a maximum of 14 with higher scores therefore indicate a better outcome. |
| Change in Parental/Caregiver Perceptions of Their Child's Power Mobility Skills Performance Between Baseline and Immediately Following the End of the Intervention Period at Week 3. | From baseline to immediately after the conclusion of the intervention period at Week 3 | This outcome will be assessed using the Canadian Occupational Performance Measure to rate parent/caregiver perceptions of their child's performance of 5 power mobility skills. Each skill is rated from a minimum of 1 to a maximum of 10. A higher score indicates a better outcome. The total score on all 5 items ranges from a minimum of 5 to a maximum of 50. A higher score indicates a better outcome. |
| Change in Child Participants' Understanding How to Use a Power Mobility Device From Immediately After the Conclusion of the Intervention Period at Week 3 to the End of the Follow-up Period at Week 7 | From immediately after the conclusion of the intervention period at Week 3 to the end of the follow-up period at Week 7 | This outcome will be assessed using each child participant's score (from a minimum of 1 to a maximal of 8) on the Assessment of Learning Powered mobility use. The Assessment of Learning Powered mobility use measures a child's understanding of how to use a power mobility device. Higher scores indicate a better outcome. |
| Change in Child Participants' Power Mobility Skill Performance Between the Conclusion of the Intervention Period at Week 3 and the End of the Follow up Period at Week 7. | From immediately after the conclusion of the intervention period at Week 3 to the end of the follow-up period at Week 7 | This outcome will be assessed using the Wheelchair Skills Checklist that evaluates a child's performance of 7 items, each reflecting a specific power mobility skill. Each item is scored from a minimum of 0 to a maximum of 2 with a higher score indicating a better outcome. Total scores for all 7 items range from a minimum of 0 to a maximum of 14 with higher scores therefore indicate a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent/Caregiver Satisfaction With the IndieTrainer System Intervention Immediately After the Conclusion of the Intervention at Week 3 | Immediately after the conclusion of the intervention at Week 3 | This outcome will be assessed through use of the Client Satisfaction Questionnaire-8 an 8-item questionnaire exploring stakeholder satisfaction with an intervention. Response choices for each item range from minimum of 1 to a maximum of 4. Higher scores indicate higher satisfaction. Total scores on the Client Satisfaction Questionnaire-8 range from a minimum of 8 to a maximum of 32. Higher total scores indicate higher satisfaction with the intervention. |
Countries
United States
Participant flow
Recruitment details
Although child-parent/caregiver dyads were enrolled in this study, only child participants received the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm: All Child Participants Receive the Intervention All child participants receive power wheelchair skills training using the IndieTrainer system.
IndieTrainer system: The IndieTrainer system is comprised of the IndieGo device and video-game modules. The IndieGo device temporarily converts a manual wheelchair into a powered wheelchair, thereby allowing children to remain in their own manual wheelchair and use their own custom seating system during power wheelchair skills training activities. The video-game modules are integrated into the IndieGo device such that the video games can be played on a TV screen using the specific access method used to control the IndieGo (i.e., switch or joystick). The IndieTrainer system is designed to allow a child to practice power wheelchair skills as part of the video-game modules or as part of more traditional power wheelchair skills training activities wherein children are able to actively explore the environment and practice executing actual wheelchair skills. Baseline data were not collected for parents/caregivers. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| Age, Continuous | 109 Months STANDARD_DEVIATION 47 |
| Assessment of Learning Powered Mobility Use | 2.24 units on a scale STANDARD_DEVIATION 0.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Change in Child Participants' Power Mobility Skill Performance Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3
This outcome will be assessed using the Wheelchair Skills Checklist that evaluates a child's performance of 7 items, each reflecting a specific power mobility skill. Each item is scored from a minimum of 0 to a maximum of 2 with a higher score indicating a better outcome. Total scores for all 7 items range from a minimum of 0 to a maximum of 14 with higher scores therefore indicate a better outcome.
Time frame: From baseline to immediately after the conclusion of the intervention period at Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm: All Child Participants Receive the Intervention | Change in Child Participants' Power Mobility Skill Performance Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3 | 1.1486 score on a scale | Standard Deviation 0.3535 |
Primary
Change in Child Participants' Power Mobility Skill Performance Between the Conclusion of the Intervention Period at Week 3 and the End of the Follow up Period at Week 7.
This outcome will be assessed using the Wheelchair Skills Checklist that evaluates a child's performance of 7 items, each reflecting a specific power mobility skill. Each item is scored from a minimum of 0 to a maximum of 2 with a higher score indicating a better outcome. Total scores for all 7 items range from a minimum of 0 to a maximum of 14 with higher scores therefore indicate a better outcome.
Time frame: From immediately after the conclusion of the intervention period at Week 3 to the end of the follow-up period at Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm: All Child Participants Receive the Intervention | Change in Child Participants' Power Mobility Skill Performance Between the Conclusion of the Intervention Period at Week 3 and the End of the Follow up Period at Week 7. | 0.0514 score on a scale | Standard Deviation 0.0911 |
Primary
Change in Child Participants' Understanding How to Use a Power Mobility Device Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3
This outcome will be assessed using each child participant's score (from a minimum of 1 to a maximal of 8) on the Assessment of Learning Powered mobility use. The Assessment of Learning Powered mobility use measures a child's understanding of how to use a power mobility device. Higher scores indicate a better outcome.
Time frame: From baseline to immediately after the conclusion of the intervention period at Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm: All Child Participants Receive the Intervention | Change in Child Participants' Understanding How to Use a Power Mobility Device Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3 | 2.68 score on a scale | Standard Deviation 0.8524 |
Primary
Change in Child Participants' Understanding How to Use a Power Mobility Device From Immediately After the Conclusion of the Intervention Period at Week 3 to the End of the Follow-up Period at Week 7
This outcome will be assessed using each child participant's score (from a minimum of 1 to a maximal of 8) on the Assessment of Learning Powered mobility use. The Assessment of Learning Powered mobility use measures a child's understanding of how to use a power mobility device. Higher scores indicate a better outcome.
Time frame: From immediately after the conclusion of the intervention period at Week 3 to the end of the follow-up period at Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm: All Child Participants Receive the Intervention | Change in Child Participants' Understanding How to Use a Power Mobility Device From Immediately After the Conclusion of the Intervention Period at Week 3 to the End of the Follow-up Period at Week 7 | 0.16 score on a scale | Standard Deviation 0.3742 |
Primary
Change in Parental/Caregiver Perceptions of Their Child's Power Mobility Skills Performance Between Baseline and Immediately Following the End of the Intervention Period at Week 3.
This outcome will be assessed using the Canadian Occupational Performance Measure to rate parent/caregiver perceptions of their child's performance of 5 power mobility skills. Each skill is rated from a minimum of 1 to a maximum of 10. A higher score indicates a better outcome. The total score on all 5 items ranges from a minimum of 5 to a maximum of 50. A higher score indicates a better outcome.
Time frame: From baseline to immediately after the conclusion of the intervention period at Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm: All Child Participants Receive the Intervention | Change in Parental/Caregiver Perceptions of Their Child's Power Mobility Skills Performance Between Baseline and Immediately Following the End of the Intervention Period at Week 3. | 6.864 score on a scale | Standard Deviation 1.4739 |
Secondary
Parent/Caregiver Satisfaction With the IndieTrainer System Intervention Immediately After the Conclusion of the Intervention at Week 3
This outcome will be assessed through use of the Client Satisfaction Questionnaire-8 an 8-item questionnaire exploring stakeholder satisfaction with an intervention. Response choices for each item range from minimum of 1 to a maximum of 4. Higher scores indicate higher satisfaction. Total scores on the Client Satisfaction Questionnaire-8 range from a minimum of 8 to a maximum of 32. Higher total scores indicate higher satisfaction with the intervention.
Time frame: Immediately after the conclusion of the intervention at Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm: All Child Participants Receive the Intervention | Parent/Caregiver Satisfaction With the IndieTrainer System Intervention Immediately After the Conclusion of the Intervention at Week 3 | 31.52 score on a scale | Standard Deviation 0.77 |