Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy
概览
- 阶段
- 不适用
- 干预措施
- Power wheelchair skills training using the IndieTrainer system
- 疾病 / 适应症
- Cerebral Palsy
- 发起方
- Grand Valley State University
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in understanding how to use a power wheelchair
- 状态
- Enrolling By Invitation
- 最后更新
- 18天前
概览
简要总结
For children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment.
研究者
Lisa Kenyon
Professor
Grand Valley State University
入排标准
入选标准
- •Diagnosis of severe CP (Gross Motor Function Classification System Level IV or V)
- •Inability to functionally walk or functionally propel a manual wheelchair as assessed by the Principal Investigator a licensed physical therapist
- •Demonstrate cause and effect skills in the IndieTrainer consistent with an Assessment of Learning Powered mobility use (ALP Assessment) Phase 4 or higher (i.e., understand that they are moving the IndieTrainer using the switch(es) or joystick) as assessed by the Principal Investigator, a licensed physical therapist.
- •In addition, one parent/caregiver must be conversant in English and be able to provide their child's medical and health history and be willing to take on the parent participant role.
排除标准
- •The inability to sit in their own manual wheelchair or adaptive stroller for 60 minutes (as this would preclude them safely using the IndieTrainer System for the 60-minute intervention sessions)
- •Their manual wheelchair or adaptive stroller cannot be safely used with the IndieTrainer System
- •They already have an individually prescribed power wheelchair
- •If the Principal Investigator, a licensed physical therapist, determines that based on the child's medical and health history, that they cannot safely participate in power wheelchair skills training.
研究组 & 干预措施
Group A: Experimental Group
Group A: The Experimental Group will receive the 8-week evidence-based PWC skills training using the IndieTrainer System following T0 baseline testing
干预措施: Power wheelchair skills training using the IndieTrainer system
Group B: Wait List Control Group
Group B: The Wait List Control Group will receive the 8-week evidence-based PWC skills training using the IndieTrainer System following T2 testing
结局指标
主要结局
Change in understanding how to use a power wheelchair
时间窗: Baseline (T0) pre-intervention, immediately after the conclusion of the 8-week intervention period (T1), and at the single session retention trial 8 weeks after the end of the intervention period (T2)
This outcome will be assessed using each participant's score (from a low of Phase 1 to a high of Phase 8) on the Assessment of Learning Powered mobility use. The Assessment of Learning Powered mobility use (ALP) is a process-based measure detailing 8 phases of learning (Phase 1 - Novice to Phase 8 - Expert) within 3 stages: Stage 1 - the Introvert Stage where the child focuses on exploring cause and effect within the function of the power mobility device; Stage 2 - the Explore Sequencing Stage where the child focuses on how to sequence the operations to maneuver the power mobility device; and Stage 3 - the Extrovert Stage where the child is focused on using the power mobility device in daily life. Higher scores therefore indicate a better outcome.
Change in power wheelchair skill performance
时间窗: Baseline (T0) pre-intervention, immediately after the conclusion of the 8-week intervention period (T1), and at the single session retention trial 8 weeks after the end of the intervention period (T2)
This outcome will be assessed using the Wheelchair Skills Checklist, a task-based measure that evaluates a child's performance of 7 specific power mobility skills using a 3-point ordinal scale from 0-2 where a score of "0" indicates the participant Does Not Perform the skill, a score of "1" indicates that the skill is Emerging, and a score of "2" indicates the participant Performs the Skill. Higher scores therefore indicate a better outcome.
次要结局
- Change in children's perceptions of changes in their performance of power wheelchair skill performance(Baseline (T0) pre-intervention and immediately after the conclusion of the 8-week intervention period (T1))
- Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance(Baseline (T0) pre-intervention and immediately after the conclusion of the 8-week intervention period (T1))