Comparing the Effect of a Graded Repetitive Arm Supplementary Home-based Exercise Programme With COgnitive-somatoSensory-MOtor Training to Improve Arm and Hand Function After Stroke (iCOSMO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Kinarm standard tasks- the Object Hit
研究概览
简要总结
The iCOSMO study investigates the feasibility and beneficial effects of an intervention combining sensation, motor and cognition to improve arm and hand function after chronic stroke.
详细描述
The iCOSMO is a two-arm randomized controlled trial study evaluating the feasibility and efficacy of combined somatosensory-motor intervention using a cognitive approach to improve upper limb recovery in people with chronic stroke. Forty participants will be recruited (20 in experimental group and 20 in the control group). iCOSMO will include active touch and movement exploratory procedures during goal-oriented tasks as well as robotic training using the Kinarm Exoskeleton device. The experimental group will receive a total of 36 hours of treatment (6 weeks). The control group will receive a matched dose of a home-based motor exercise programme. The outcome measures will include measures of feasibility such as the recruitment and adherence rates and standardised clinical and robotic assessments. The participants will be tested at the start and end of the baseline phase, at post-intervention and at 1-month follow-up.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants will be blinded to the hypotheses being tested in this study i.e the participant will not be informed about the feasibility testing of the iCOSMO training intervention. The participants will also not be informed which amongst the two interventions is the experimental or control interventions, respectively. The outcome assessor will be blinded to the intervention delivered to participants.
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
- •Clinical diagnosis of stroke
- •Must be more than 6 months post-stroke
- •Must be above 18 years old
- •Must have some motor and/or somatosensory deficits in the upper limbs
排除标准
- •A prior history of central nervous system dysfunction other than stroke
- •Upper limb deficits resulting from non-stroke pathology
- •Inability to cooperate, follow instructions or provide consent
结局指标
主要结局
Kinarm standard tasks- the Object Hit
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Object Hit. The Object Hit task is a rapid sensorimotor decision and control test. A task score will be reported as a measure of a participant's performance against healthy populations.
Action Research Arm Test (ARAT)
时间窗: Baseline, immediately after intervention,1-month
The ARAT assesses motor performance of the upper limb. It consists of 19 tasks across the 4 subscales (grasp, grip, pinch, gross movement).
Grip dynamometry
时间窗: Baseline, immediately after intervention,1-month
Maximum voluntary grip strength with the Jamar dynamometer will be used as a conventional measure of muscle strength in the upper limb post-stroke.
Box and Block Test (BBT)
时间窗: Baseline, immediately after intervention,1-month
The BBT will be used to assess gross manual dexterity.
Kinarm standard tasks- the Trail Making A&B
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Trail Making A\&B. The Trail Making tests evaluate task switching abilities. There are 2 parts of this test. Trail A: trace a sequence of targets numbered 1 to 25; Trail B: Trace alternating numeric-alpha sequence of targets 1-A-2-B etc. A task score will be reported as a measure of a participant's performance against healthy populations.
Kinarm standard tasks- the Spatial Span Task
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Spatial Span Task. The Spatial Span test evaluates visuospatial working memory. A task score will be reported as a measure of a participant's performance against healthy populations.
Kinarm standard tasks- the Paired Associates Learning
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Paired Associates Learning. The Paired Associates Learning task evaluates visuospatial working memory by testing the ability to associate patterns with spatial locations and recall them after a delay. A task score will be reported as a measure of a participant's performance against healthy populations.
Kinarm standard tasks- the Ball-on-Bar
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Ball-on-Bar. The Ball on Bar task assesses bimanual coordination and visuomotor skills. A task score will reported as a measure of a participant's performance against healthy populations.
Kinarm standard tasks- the Arm Positioning Matching
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Arm Positioning Matching: The Arm Position Matching task measures of a subject's proprioceptive capabilities in the upper limb. A task score will be reported as a measure of a participant's performance against healthy populations.
Pinch strength
时间窗: Baseline, immediately after intervention,1-month
Pulp-to-pulp pinch strength will be assessed using a pinch gauge (B \& L Engineering).
Fidelity
时间窗: Through study completion, an average of 6 weeks
Measures of fidelity will monitor intervention delivery such as the number of intervention sessions attended and the amount of practice.
Kinarm standard tasks- the Reverse Visually Guided Reaching
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Reverse Visually Guided Reaching. The Reverse Visually Guided Reaching task assesses attention, inhibitory control and cognitive control of visuomotor skills. A task score will be reported as a measure of a participant's performance against healthy populations.
Kinarm standard tasks- the Object Hit and Avoid
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Object Hit and Avoid. The Object Hit and Avoid task assesses spatial attention, rapid motor selection and inhibition control. A task score will be reported as a measure of a participant's performance against healthy populations.
Kinarm standard tasks- the Arm Posture Perturbation
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Arm Posture Perturbation. The Arm Posture Perturbation task assesses the responsiveness to unexpected disturbances to the arm. A task score will reported as a measure of a participant's performance against healthy populations.
Kinarm standard tasks- the Arm Movement Matching
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Arm Movement Matching: The Arm Movement Matching task assesses the ability of a subject to perceive limb motion or kinesthesia in a workspace. A task score will be reported as a measure of a participant's performance against healthy populations.
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
时间窗: Baseline, immediately after intervention,1-month
FMA-UE provides quantitative measures of sensory and motor impairments in the upper limbs and is scored from 0-66.
Kinarm standard tasks- the Visually Guided Reaching
时间窗: Baseline, immediately after intervention,1-month
The Kinarm standard tasks™ will include the Visually Guided Reaching. The Visually Guided Reaching task measures the subject's visuomotor capabilities and multi-joint coordination. A task score will reported as a measure of a participant's performance against healthy populations.
次要结局
- Pain visual analogue scale (PVAS)(Through study completion, an average of 6 weeks)
- Stanford Fatigue Visual Analogue Scale (SFVAS)(Through study completion, an average of 6 weeks)
研究者
Mark Bayley
Medical Director
University Health Network, Toronto