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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
The home-based exercise programme will be based on the Home Graded Repetitive Arm Supplementary Program focusing on stretching, arm strengthening, hand strengthening, coordination and hand skills. The Home Graded Repetitive Arm Supplementary Program will be delivered 2 hours/session, 3 times/week, for 6 weeks.
The first training approach of iCOSMO will focus on integrated somatosensory-motor variables during reaching and object manipulation (60 minutes). The second training approach will focus on proprioceptive, motor and cognitive tasks using the Kinarm robotic exoskeleton (60 minutes). iCOSMO will be delivered 3 times per week (2 hours per session) for 6 weeks (Total: 36 hours of treatment).
Toronto Rehabilitation Institute
Toronto, Ontario, Canada
RECRUITINGFidelity
Measures of fidelity will monitor intervention delivery such as the number of intervention sessions attended and the amount of practice.
Time frame: Through study completion, an average of 6 weeks
Kinarm standard tasks- the Reverse Visually Guided Reaching
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.
Time frame: Baseline, immediately after intervention,1-month
Kinarm standard tasks- the Trail Making A&B
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.
Time frame: Baseline, immediately after intervention,1-month
Kinarm standard tasks- the Object Hit and Avoid
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.
Time frame: Baseline, immediately after intervention,1-month
Kinarm standard tasks- the Spatial Span Task
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.
Time frame: Baseline, immediately after intervention,1-month
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Kinarm standard tasks- the Paired Associates Learning
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.
Time frame: Baseline, immediately after intervention,1-month
Kinarm standard tasks- the Visually Guided Reaching
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.
Time frame: Baseline, immediately after intervention,1-month
Kinarm standard tasks- the Object Hit
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.
Time frame: Baseline, immediately after intervention,1-month
Kinarm standard tasks- the Ball-on-Bar
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.
Time frame: Baseline, immediately after intervention,1-month
Kinarm standard tasks- the Arm Posture Perturbation
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.
Time frame: Baseline, immediately after intervention,1-month
Kinarm standard tasks- the Arm Positioning Matching
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.
Time frame: Baseline, immediately after intervention,1-month
Kinarm standard tasks- the Arm Movement Matching
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.
Time frame: Baseline, immediately after intervention,1-month
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
FMA-UE provides quantitative measures of sensory and motor impairments in the upper limbs and is scored from 0-66.
Time frame: Baseline, immediately after intervention,1-month
Action Research Arm Test (ARAT)
The ARAT assesses motor performance of the upper limb. It consists of 19 tasks across the 4 subscales (grasp, grip, pinch, gross movement).
Time frame: Baseline, immediately after intervention,1-month
Grip dynamometry
Maximum voluntary grip strength with the Jamar dynamometer will be used as a conventional measure of muscle strength in the upper limb post-stroke.
Time frame: Baseline, immediately after intervention,1-month
Pinch strength
Pulp-to-pulp pinch strength will be assessed using a pinch gauge (B \& L Engineering).
Time frame: Baseline, immediately after intervention,1-month
Box and Block Test (BBT)
The BBT will be used to assess gross manual dexterity.
Time frame: Baseline, immediately after intervention,1-month
Stanford Fatigue Visual Analogue Scale (SFVAS)
The SFVAS, a single-item scale with a rating of 1 (no fatigue) to 10 (severe fatigue), will be used to assess the presence and extent of mental and physical fatigue.
Time frame: Through study completion, an average of 6 weeks
Pain visual analogue scale (PVAS)
PVAS is a single-item scale ranging from 0 (no pain) to 10 (excruciating pain).
Time frame: Through study completion, an average of 6 weeks