Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Walking ability - Functional Ambulation Category
研究概览
简要总结
To determine the effect of using a robotic exoskeleton to allow walking practice after stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary outcomes.
详细描述
Participants admitted to inpatient stroke rehabilitation for physiotherapy services will be randomly assigned to either the Exoskeleton Program or Usual Care Program.
Individuals in the Exoskeleton Program will have their usual physiotherapy sessions replaced with the exoskeleton intervention. The exoskeleton will allow standing and walking from the first sessions in rehabilitation, as the exoskeleton provides the physical support to allow walking in full weight-bearing without being limited by therapist fatigue and lifting requirements. Individuals in the Usual Care Program will receive standard physiotherapy care, which is individualized and hands-on with their therapist to regain walking, mobility, and independent function.
Both groups will be conducted 3-5 days a week, 30-60 minutes per session until discharge (to a maximum of 8 weeks). Participants will be assessed at baseline, discharge, and 6-months after starting rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been admitted to a hospital unit for stroke treatment
- •Stroke within last 3 months
- •One-sided hemiparesis
- •19 years or older
- •Requires 2-person assist to walk
- •Able to communicate and follow instructions
- •Prescribed to receive physiotherapy care
排除标准
- •Stroke of non-vascular origin (e.g. tumour, infection)
- •Significant musculoskeletal or other neurological condition
- •Co-morbidities that would preclude activity
- •Unable to walk prior to stroke
- •<60 inches or >74 inches in height
- •>220 pounds in weight
- •Joint contractures or spasticity that would limit safe use of the Ekso exoskeleton
结局指标
主要结局
Walking ability - Functional Ambulation Category
时间窗: Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)
次要结局
- 5-Metre Walk Test (5MWT)(Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission)
- Berg Balance Scale (BBS)(Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission)
- Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower)(Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission)
- 6-Minute Walk Test (6MWT)(Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission)
- Health-related Quality of Life (SF-36)(Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission)
- Days to independent walking(Discharge (generally 4-6 weeks, up to 8 weeks))
- Depressive Symptoms (PHQ-9)(Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission)
- Functional Ambulation Category(6 Months from admission)
- Cognition - Montreal Cognitive Assessment (MoCA)(Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission)
- Daily step count(6 months from admission)
研究者
Janice Eng
Principal Investigator
University of British Columbia