COgnitive-somatoSensory-MOtor Training to Improve Arm and Hand Function After Stroke (iCOSMO)

Not Applicable

Recruiting

• Conditions: CVA; Cerebrovascular Accident; Stroke
• Interventions: Other: integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO); Other: Home Graded Repetitive Arm Supplementary Program (GRASP)

• Registration Number: NCT06498011
• Lead Sponsor: University Health Network, Toronto

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-07-05
• Study First Posted: 2024-07-12
• Study Start: 2024-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2027-07-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iCOSMO	integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO)	20 participants will receive the iCOSMO intervention. iCOSMO consists of two training approaches that will include active touch and movement exploratory procedures during goal-oriented tasks as well as robotic training using the Kinarm Exoskeleton device.
Home GRASP	Home Graded Repetitive Arm Supplementary Program (GRASP)	20 participants will receive the control intervention. The control group will receive a matched dose of a home-based exercise programme. The home-based exercise programme will be based on the Home Graded Repetitive Arm Supplementary Program.

Primary Outcome Measures

Name	Time	Method
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.
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).
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.
Box and Block Test (BBT)	Baseline, immediately after intervention,1-month	The BBT will be used to assess gross manual dexterity.
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 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 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 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.
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 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 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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

Toronto Rehabilitation Institute; 🇨🇦 Toronto, Ontario, Canada