COgnitive-somatoSensory-MOtor Training to Improve Arm and Hand Function After Stroke (iCOSMO)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Home Graded Repetitive Arm Supplementary Program (GRASP)
Other interventionThe 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.
integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO)
Other interventionThe 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).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: iCOSMOExperimental treatment 1 intervention
Group B: Home GRASPActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fidelity
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 weeks2
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-month3
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-month4
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-monthSecondary outcomes
1
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 weeks2
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
StrokeCog clinical training platform
Collaborator
Source ClinicalTrials.gov