COgnitive-somatoSensory-MOtor Training to Improve Arm and Hand Function After Stroke (iCOSMO)
NCT Number: NCT06498011
Acronym: iCOSMO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|CVA|Cerebrovascular Accident
Interventions: OTHER: Home Graded Repetitive Arm Supplementary Program (GRASP)|OTHER: integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO)
Sponsor: University Health Network, Toronto
Collaborators: StrokeCog clinical training platform
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-12-31
Locations: Urvashy Gopaul, Toronto, Ontario, M5G2A1, Canada

Summary:
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.

Primary Outcome Measures: Fidelity, Measures of fidelity will monitor intervention delivery such as the number of intervention sessions attended and the amount of practice., 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., 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., 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., 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., Baseline, immediately after intervention,1-month|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., 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., 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., 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., 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., 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., 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., 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., 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)., 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., Baseline, immediately after intervention,1-month|Pinch strength, Pulp-to-pulp pinch strength will be assessed using a pinch gauge (B \& L Engineering)., Baseline, immediately after intervention,1-month|Box and Block Test (BBT), The BBT will be used to assess gross manual dexterity., Baseline, immediately after intervention,1-month
Secondary Outcome Measures: 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., 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)., Through study completion, an average of 6 weeks