Robot-based Therapy for Upper Limb Sensorimotor Impairments in the Chronic Phase After Stroke: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Kinarm: sensory processing task
研究概览
简要总结
After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. Current evidence on treatment of upper limb sensory impairments is scarce and shows unclear results. Robot-based therapy has been increasingly used to treat upper limb motor impairments, with similar positive results as compared to conventional therapy. This study aims to investigate a novel robot-based therapy program for treatment of upper limb sensory impairments. The therapy program consists of 10 one-hour session spread over 4 weeks and will be evaluated for its effect in 20 chronic stroke patients. The investigators hypothesize that a 4-week robot-based therapy program can improve upper limb sensation and movement.
详细描述
Up to 70% of stroke survivors show upper limb impairments consisting of motor and/or somatosensory impairments. These impairments often persist well into the chronic stage, and may lead to significant limitations in activities of daily living and may negatively affect quality of life. Different interventions have been investigated to treat upper limb motor impairments, including robot-based therapy, which shows similar positive results as compared to conventional therapy. Evidence on interventions for somatosensory impairments is scarce and often of low quality. This study therefore aims to evaluate the effect of a robot-based therapy program on sensorimotor function of the upper limb in a group of 20 chronic stroke patients.
The robot-based therapy will be provided using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada) and consists of passive and active therapy tasks for proprioception and sensory processing. The therapy consists of 10 one-hour sessions spread over 4 weeks. Clinical and robot-based motor and somatosensory assessments will be performed at 4 time points: twice at baseline, once at mid intervention, and once after 10 hours of therapy. The investigators hypothesize to find improvement in both upper limb motor and somatosensory function after the therapy program. The results from this pilot study will provide a basis for further research.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •A first-ever unilateral, supratentorial stroke (as defined by WHO)
- •In the chronic phase after stroke (i.e. being at least 6 months after stroke)
- •Motor deficits of the upper limb (Fugl-Meyer Motor Assessment - Upper Extremity < 60/66)
- •Somatosensory deficits of the upper limb (Erasmus modified Nottingham Sensory Assessment < 36/40)
- •Ability to perform, at least to some extent, active shoulder abduction and wrist extension against gravity
- •Ability to perform passive and active sensory processing assessment task (primary outcome measure)
排除标准
- •History of previous stroke or TIA
- •Any serious musculoskeletal and/or other neurological conditions
- •Serious communication or cognitive deficits
- •No written informed consent
研究组 & 干预措施
Robot-based therapy
Chronic stroke patients receiving robot-based therapy
干预措施: Robot-based therapy (Device)
结局指标
主要结局
Kinarm: sensory processing task
时间窗: Change during 4 weeks of therapy provided at least 6 months after stroke
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
次要结局
- Kinarm: arm movement matching task(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Kinarm: visually guided reaching task(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Tactile discrimination test(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Action research arm test(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Erasmus modified Nottingham sensory assessment(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Kinarm: sensory processing task(Change during the last 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke)
- Kinarm: arm position matching task(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Fugl-Meyer upper extremity assessment(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Kinarm: working memory task(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Functional tactile object recognition test(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Sensorimotor action research arm test(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Star cancellation test(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Montreal cognitive assessment(Change during 4 weeks of therapy provided at least 6 months after stroke)
- Kinarm: sensory processing task(Change in 2 baseline measures taken 2 days apart, at least 6 months after stroke)
- Kinarm: sensory processing task(Change during the first 2 weeks of a 4-week therapy protocol provided at least 6 months after stroke)
研究者
Prof Geert Verheyden
Professor Neurorehabilitation
KU Leuven