Robotic Walking for Children Who Cannot Walk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Training Time
研究概览
简要总结
A common problem among children with nervous system disorders is difficulty walking on their own. This has impacts beyond mobility including short and long-term health conditions associated with physical inactivity and different developmental experiences as a result of the mobility impairments. A robotic trainer can both provide rehabilitation and be an assistive device to help compensate for difficulties. Figuring out how to prescribe it is critical to improve daily life for children with significant disabilities. Preliminary use of robotic trainers have shown many benefits, such as better head control and improved independence in transfers, which greatly increases ability to live independently. Additionally, vital functions that are frequently impaired in those with less physical activity, such as sleep and bowel habits, seem to improve. Finally, these children enjoy using them.
This project aims to determine who is most likely to benefit from training with a robotic trainer and investigate key details about the dose of training that is needed. Families that are already using or hope to use robotic training need this data to help improve their access to the intervention. Clinicians need this systematic approach to building evidence to ensure a future multi-centre randomized control trial is well designed. This study is needed to help improve the lives of those who live with significant disabilities. The objective is to evaluate the feasibility and impacts of delivering robotic gait training at home. Integral in this study is capturing the user perspectives. This will both provide preliminary evidence-based advice to potential users, their families, and clinicians as well as provide key metrics to design a definitive multi-centre randomized control trial.
The investigators will provide robotic gait trainers, specifically Trexo robotic gait trainers, to participants and their families to use in their home communities for 12 weeks to evaluate the feasibility and impacts of intensive robotic gait training in people who cannot walk independently. Assessments will be completed throughout the duration of study, including before, during, and after the training intervention, with the goal of evaluating a wide range of feasibility considerations and impacts from robotic training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Because there is only 1 arm in the study, and each participant proceeds through the same study timeline, participants, care providers, investigators, and outcome assessors will know the intervention received.
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 4 years of age
- •Unable to walk independently due to pediatric onset, non-progressive central nervous system disorder or injury (ie. cerebral palsy or acquired brain injury)
- •Able to fit into Trexo robotic gait trainer (both leg length and weight)
- •Able to fulfill training requirements throughout training period (5 days/week for at least 30 minutes each session)
- •Able to comply with study procedures (assessments, training)
排除标准
- •Medical condition or recent surgery requiring lower extremity immobilization or weight-bearing restrictions (ie. fracture, unstable hip subluxation).
- •Medical condition requiring a physical activity restriction (ie. unstable arrhythmia).
- •Pain or symptomatic hypotension while standing.
- •Contracture such that the Trexo robotic gait trainer does not result in forward movement.
- •Current involvement in a potentially confounding intervention (determined on a case-by-case basis).
研究组 & 干预措施
Robotic Training Period
Participants will engage in robot assisted gait training on at least 5 days/week for at least 30 minutes each day, for a total period of 12 weeks.
干预措施: Robotic Training Period (Device)
结局指标
主要结局
Training Time
时间窗: Assessed throughout the 12 weeks (Week 5 through Week 16) robotic training period.
Time spent in the trainer each session, total time spent in the trainer (weekly, monthly).
Early Clinical Assessment of Balance (ECAB)
时间窗: Assessed monthly from time of enrollment through 3-months post-training.
Clinical balance assessment to determine participant's balance capabilities.
Canadian Occupational Performance Measures (COPM)
时间窗: Assessed at enrollment (Week 0), before Robotic Gait Training period (~Week 4), following Robotic Gait Training period (~Week 16), and at 3-months post-training (~Week 28).
Structured questions and rating scales to determine problem areas and goals for training. Identified problems are scored on a 10 point scale, 1 being not able to complete the task at all.
Training Frequency
时间窗: Assessed throughout the 12 week (Week 5 through Week 16) robotic training period.
Frequency of training sessions (days/week).
Goal Attainment Scaling
时间窗: Assessed at enrollment (Week 0), before Robotic Gait Training period (~Week 4), following Robotic Gait Training period (~Week 16), and at 3-months post-training (~Week 28).
Rating of success in achieving an outcome or desired goal (identified using the COPM), where 0 = the expected level of achievement, -2 = much less achieved than expected, and +2 = much more achieved than expected.
次要结局
- EQ-5D-Y (Youth)(Assessed before (~Week 4) and after (~Week 16) robotic gait training.)
- CarerQOL(Assessed before (~Week 4) and after (~Week 16) robotic gait training.)
- Head Control While Walking(Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28)..)
- Bowel Function(Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28)
- Number of Participants Enrolled and Completed(Assessed throughout the study duration, an average of 7-9 months depending on time of enrollment..)
- Focus Groups(Assessed before (~Week 4) and after (~Week 16) robotic gait training.)
- Seated Limits of Stability(Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).)
- Ramp & Hold(Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).)
- Voluntary Muscle Activity(Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).)
- PROMIS Sleep Disturbance Questionnaire(Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).)
- Heart Rate Reserve(Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28)
- Sleep Duration(Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28)
- Caregiver Priorities & Child Health Index of Life with Disabilities (CP-CHILD)(Assessed before (~Week 4) and after (~Week 16) robotic gait training.)
- Modified Tardieu Scale(Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).)
- Habitual Activity Estimation Scale (HAES)(Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).)
- Distance Walked(Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28)
研究者
Elizabeth Condliffe, PhD MD
Assistant Clinical Professor
University of Calgary