Clinical trial NCT06498011: COgnitive-somatoSensory-MOtor Training to Improve Arm and Hand Function After Stroke (iCOSMO)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
CVA
Cerebrovascular Accident
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: StrokeCog clinical training platform
First posted: 2024-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fidelity
timeFrame: Through study completion, an average of 6 weeks
measure: Kinarm standard tasks- the Reverse Visually Guided Reaching
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Trail Making A&B
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Object Hit and Avoid
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Spatial Span Task
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Paired Associates Learning
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Visually Guided Reaching
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Object Hit
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Ball-on-Bar
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Arm Posture Perturbation
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Arm Positioning Matching
timeFrame: Baseline, immediately after intervention,1-month
measure: Kinarm standard tasks- the Arm Movement Matching
timeFrame: Baseline, immediately after intervention,1-month
measure: Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
timeFrame: Baseline, immediately after intervention,1-month
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline, immediately after intervention,1-month
measure: Grip dynamometry
timeFrame: Baseline, immediately after intervention,1-month
measure: Pinch strength
timeFrame: Baseline, immediately after intervention,1-month
measure: Box and Block Test (BBT)
timeFrame: Baseline, immediately after intervention,1-month
Secondary outcomes:
measure: Stanford Fatigue Visual Analogue Scale (SFVAS)
timeFrame: Through study completion, an average of 6 weeks
measure: Pain visual analogue scale (PVAS)
timeFrame: Through study completion, an average of 6 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Mark Bayley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gopaul U, van Vliet P, Callister R, Nilsson M, Carey L. COMbined Physical and somatoSEnsory training after stroke: Development and description of a novel intervention to improve upper limb function. Physiother Res Int. 2019 Jan;24(1):e1748. doi: 10.1002/pri.1748. Epub 2018 Sep 19.
citation: Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.
citation: Ritter PL, Gonzalez VM, Laurent DD, Lorig KR. Measurement of pain using the visual numeric scale. J Rheumatol. 2006 Mar;33(3):574-80.
citation: Bourke TC, Lowrey CR, Dukelow SP, Bagg SD, Norman KE, Scott SH. A robot-based behavioural task to quantify impairments in rapid motor decisions and actions after stroke. J Neuroeng Rehabil. 2016 Oct 10;13(1):91. doi: 10.1186/s12984-016-0201-2.
citation: Duncan PW, Propst M, Nelson SG. Reliability of the Fugl-Meyer assessment of sensorimotor recovery following cerebrovascular accident. Phys Ther. 1983 Oct;63(10):1606-10. doi: 10.1093/ptj/63.10.1606.
citation: Ekstrand E, Lexell J, Brogardh C. Grip strength is a representative measure of muscle weakness in the upper extremity after stroke. Top Stroke Rehabil. 2016 Dec;23(6):400-405. doi: 10.1080/10749357.2016.1168591. Epub 2016 May 4.
citation: Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.