Quantifying the User Experience, as Well as Neural, Muscular, and Functional Gait Changes Following Exoskeleton-powered Gait Rehabilitation in Children With Mobility Impairments
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Resting State Functional Magnetic resonance imaging (MRI) - changes from Baseline
研究概览
简要总结
Non-ambulatory children with cerebral palsy (CP) and similar childhood-onset neuromotor conditions face many challenges to fulsome participation in everyday life. Recent initial phase research suggests that physiotherapy paired with use of robotic exoskeletons, such as the Trexo exoskeleton ("The Trexo"; Trexo Robotics, Canada) provides a novel opportunity for children with severe mobility challenges to experience active walking that is individualized to their movement potential (guiding and powering leg movements) and upright support needs. This before-and-after study will assess the first-time experience of 10 non-ambulatory children (ages 4-7) using the Trexo for 6 weeks of twice weekly physiotherapy sessions, and evaluate associated brain, muscle and functional outcomes including accomplishment of individualized goals. To study clinical utility, we will simultaneously capture physiotherapists' (PTs) and PT assistants' (PTAs) training/learning/user experiences with the Trexo's first time use within our center's out-patient program and on-site affiliated school.
This project will contribute evidence-based knowledge to guide clinical decisions about introduction of the Trexo within pediatric rehabilitation settings (target demographic, potential goals, integration into physiotherapy) and be a foundation for a progressive program of multi-centre research. Overall, we hope that this research will lead to better opportunities for children's meaningful participation within the community, including family and peers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight of 50-100 lbs (23- 46 kgs), leg length (hip to floor): 40-56c
- •GMFCS Level IV equivalent
- •Knee and hip range of motion sufficient to allow exoskeleton fit (see exclusion criteria)
- •Able to follow GMFM testing instructions, and able to participate in a minimum of 30 minutes of active PT
- •Able to reliably signal pain, fear and discomfort
- •At least 2 months after any lower limb Botulinum Toxin (BTX) injections
- •Will be safe for BTX to be put on hold during their study participation (i.e., a period of 6 months which is equivalent to one BTX treatment cycle).
排除标准
- •Any weightbearing restrictions
- •Fixed knee contracture (passive) > 20 degrees, knee valgus >40 degrees such that orthosis will not be adaptable to lower limbs. Note: Fixed hip and ankle contractures in themselves are not a contraindication for Trexo
- •Hip subluxation > 40% unless with orthopedic clearance for weight bearing with the Trexo
- •Orthopaedic surgery within the last 9 months (if muscle) or 12 months (if bone)
- •Severe spasticity may be a contraindication (still OK to consider)
- •Seizure disorder that is not controlled by medication. For a child on seizure medication, must not have had a seizure in the last 12 months (as verified by the child's treating physician)
- •Open skin lesions or vascular disorder of lower extremities
- •Osteogenesis imperfecta
- •Not able to co-operate for positioning/adjustments within the Trexo
- •Involved in another intervention study (any type). May be concurrently enrolled though in a single point assessment study (e.g., annual follow-up of status, measurement study)
结局指标
主要结局
Resting State Functional Magnetic resonance imaging (MRI) - changes from Baseline
时间窗: Baseline, following 6 weeks of intervention, 1 month post-intervention
Whole-brain analysis based on BOLD signal changes
Mechanomyography (MMG) - changes from Baseline
时间窗: Baselines, following 6 weeks of intervention, 1 month post-intervention
Non-invasive acoustic skeletal muscle recordings (frequency and amplitude)
Canadian Occupational Performance Measure (COPM) - changes from Baseline
时间窗: Weekly check-ins for 6 weeks
Parent reported qualitative questionnaire for gait related goals
Goal Attainment Scaling (GAS) - changes from Baseline
时间窗: Weekly check-ins for 6 weeks
Physiotherapist reported qualitative questionnaire for gait related goals; scored -2 to +2
Structural Magnetic resonance Imaging (MRI) - changes from Baseline
时间窗: Baseline, following 6 weeks of intervention, 1 month post-intervention
T1 anatomical scan - grey and white matter volumes
Gross Motor Function Measure (GMFM)-88 - changes from Baseline
时间窗: Baselines, following 6 weeks of intervention, 1 month post-intervention
Standard for measuring gross motor skills in children with CP and related neuromotor disorders
Diffusion Magnetic resonance imaging (MRI) - changes from Baseline
时间窗: Baseline, following 6 weeks of intervention, 1 month post-intervention
Multi shell diffusion imaging - kurtosis fractional anisotropy measures
次要结局
- Passive range of motion (ROM) - changes from Baseline(Baselines, following 6 weeks of intervention, 1 month post-intervention)
- PEDI-CAT Questionnaire - changes from Baseline(Baselines, following 6 weeks of intervention, 1 month post-intervention)
- Directional Mobility Assessment (DMA) - changes from Baseline(Baselines, following 6 weeks of intervention, 1 month post-intervention)
- The Sitting Assessment for Children with Neuromotor Dysfunction (SACND) - changes from Baseline(Baselines, following 6 weeks of intervention, 1 month post-intervention)