Cerebrovascular Accident, CVA, Stroke
Conditions
Brief 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.
Detailed description
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.
Interventions
OTHERHome Graded Repetitive Arm Supplementary Program (GRASP)
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.
OTHERintegrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO)
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).
Sponsors
University Health Network, Toronto
StrokeCog clinical training platform
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test (BBT) | Baseline, immediately after intervention,1-month | The BBT will be used to assess gross manual dexterity. |
| Grip dynamometry | 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. |
| Pinch strength | Baseline, immediately after intervention,1-month | Pulp-to-pulp pinch strength will be assessed using a pinch gauge (B & L Engineering). |
| Fidelity | 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 | 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 Trail Making A&B | 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 Object Hit and Avoid | 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 Spatial Span Task | 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 | 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 Visually Guided Reaching | 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. |
| Kinarm standard tasks- the Object Hit | 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. |
| Kinarm standard tasks- the Ball-on-Bar | 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 Posture Perturbation | 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 Positioning Matching | 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. |
| Kinarm standard tasks- the Arm Movement Matching | 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) | 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. |
| Action Research Arm Test (ARAT) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain visual analogue scale (PVAS) | Through study completion, an average of 6 weeks | PVAS is a single-item scale ranging from 0 (no pain) to 10 (excruciating pain). |
| Stanford Fatigue Visual Analogue Scale (SFVAS) | Through study completion, an average of 6 weeks | 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. |
Countries
Canada
Contacts
Primary ContactUrvashy Gopaul, PhD
Backup ContactOlga Yaroslavtseva, BSc
Outcome results
None listed