Personalized Upper Extremity Rehabilitation for Persons With Moderate and Severe Impairments Due to Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change from baseline Box and Blocks Test at 6 weeks
研究概览
简要总结
Approximately 80% of individuals with chronic stroke present with long lasting upper extremity (UE) impairments. Advances in rehabilitation technology, such as robotics, virtual reality (VR) and neuromuscular electrical stimulation (NMES), have separately demonstrated their effectiveness in improving UE function of individuals with stroke. The potential to influence recovery may be further enhanced by combining these modalities in order to target motor deficits of the individual. Research has shown that not all persons with stroke may be able to recover hand function. In particular, such recovery depends on the integrity of the corticospinal tract (CST), which links the motor areas of the brain to the UE (and hand) musculature. Instead of using a 'one-size-fits-all' approach to UE rehabilitation, CST integrity will be assessed through transcranial magnetic stimulation (TMS), a non-invasive approach, and match the intervention to the individual's specific impairments. The perSonalized UPper Extremity Rehabilitation (SUPER) intervention is proposed, which combines robotics, VR activities, and NMES. The objectives of this study are to determine the feasibility of the SUPER intervention in individuals with moderate/severe stroke. Stroke participants will receive a 5-week intervention (3x per week) combining robotic therapy and VR activities, based on their functional level. Those with low potential for hand recovery will receive an intervention focussing on elbow and shoulder movements. For those with a good potential for hand recovery, the last 30 minutes of the robotic or VR session will be complemented by muscle-triggered NMES. Feasibility indicators associated with process, resources, management and treatment will be measured. Outcomes of UE and hand function will include the Fugl-Meyer upper extremity assessment, the Box and Block test and the ABILHAND. It is expected that feasibility criteria will be met and that the SUPER intervention will lead to significant improvements in UE impairment compared to a waitlist group.
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
Assessor blinded to intervention and study's objectives
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic or hemorrhagic stroke
- •moderate to severe UE impairment (score between 2 and 4 out of 7 on the Chedoke-McMaster each of the arm and hand components
- •at least 3 months post stroke
- •no longer receiving rehabilitation services.
排除标准
- •medical instability
- •marked cognitive deficits (MiniCog score 2 or lower)
- •uncorrected visual impairments
- •shoulder pain that would limit participation in the study
- •severe spasticity at the affected UE
研究组 & 干预措施
Intervention
Upper extremity rehabilitation
干预措施: Upper extremity rehabilitation (Device)
结局指标
主要结局
Change from baseline Box and Blocks Test at 6 weeks
时间窗: 6 weeks
A measure of gross motor dexterity
Change from baseline ABILHAND at 6 weeks
时间窗: 6 weeks
A questionnaire to assess active function of the upper limbs with 23 activities, rated as impossible, difficult or easy. The scale is scored through Rasch analysis, providing a total score ranging from -6 to +6, with higher scores indicating a lower degree of upper extremity impairment.
Change from baseline Fugl-Meyer Assessment (Upper extremity section) at 6 weeks
时间窗: 6 weeks
A performance-based measure of UE impairment describing motor recovery
次要结局
- Change from baseline Motor Activity Log at 6 weeks(6 weeks)
- Change from baseline Grip Strength at 6 weeks(6 weeks)
- Change from baseline Stroke Impact Scale at 6 weeks(6 weeks)
研究者
Philippe Archambault
Associate Professor
McGill University
