Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Enrollment and recruitment in this study design
研究概览
简要总结
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.
详细描述
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.
The primary objective is to assess feasibility of the study design and device tolerability. Specifically:
- Recruitment success (number screened, number eligible, number enrolled) where 80% of the recruitment target is reached.
- Attrition rates of less than 10% (i.e. ≥90% of participant's successfully complete assessments).
- Adherence for each participant: 80% of participants who complete assessments achieve the minimum target dose (i.e. approx. ≥30 hours of therapy in both study groups).
- Qualitative feedback from clinicians and patients/caregivers on device tolerability and study participation.
Secondary objectives will evaluate the distance a child can walk in two minutes using the Two Minute Walk Test (2MWT, 18) and will examine a more global impact of the use of this technology. Data collected will include quality of gait, child or proxy chosen individualized goals, hypertonicity, contractures, and bone health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of cerebral palsy
- •GMFCS Levels III and IV
- •Ages ≥2 to ≤12 years
- •Ability to take steps with and/or without assistance
- •Meet the Trexo Plus device size requirements
- •Ability to follow instructions and signal pain, fear, or discomfort
- •Ability to safely use the device at home as determined by the study team
排除标准
- •Lower limb or orthopedic surgery within 9 months prior to enrollment
- •Botulinum toxin injections within 4 months prior to enrollment
- •Serial casting within 3 months prior to enrollment
- •Knee flexion contracture > 20°
- •Knee valgus > 40°
- •Hip subluxation > 40 % migration percentage
- •Uncontrolled movements that prevent transfer in and/or out of device
- •Weight bearing restrictions
- •Uncontrolled seizures
- •Skin lesions in areas where the device straps would be attached
- •Significant language barrier with parents and/or caregivers Note: children with severe contractures will be unable to fit in the device and are therefore excluded from the study
结局指标
主要结局
Enrollment and recruitment in this study design
时间窗: 4 months
Recruitment success as defined by meeting 80% of the recruitment target
Retention in this study design
时间窗: 4 months
Attrition of less than 10% where 90% of participants are completing the assessments to the end of the trial
Adherance to protocol for each participant
时间窗: 4 months
Participant self-reported session diaries will be assessed to determine whether participants are achieving the min target dose of 30h of therapy over each 8 week session
Device tolerability
时间窗: 4 months
Participant caregivers will be interviewed for qualitative feedback on device/therapy tolerability after each 8 week session
次要结局
- Hypertonia Assessment Tool(4 months)
- Modified Ashworth Scale(4 months)
- 2 minute walk test (2mwt)(4 months)
- Physiological Cost Index(4 months)
- Barry Albright Dystonia Scale(4 months)
- Goal attainment scale(4 months)
- Edinburgh Visual Gait Score(4 months)
- Spinal Alignment and Range of Motion Measure(4 months)
- Leg bone cortical cross-sectional area(4 months)
- Leg Bone cortical density(4 months)
- Tibia volumetric bone mineral density (BMD)(4 months)
研究者
Anna McCormick
Pediatrician / Physical Medicine and Rehabilitation Specialist, Division Chief Developmental Medicine and Rehabilitation
Children's Hospital of Eastern Ontario