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

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)

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Urvashy Gopaul, PhD; Phone Number: 7996 416-597-3422; Email: urvashy.gopaul@uhn.ca
• Study Contact Backup: Name: Olga Yaroslavtseva, BSc; Phone Number: 7858 416-597-3422; Email: olga.yaroslavtseva@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2A1
      • Recruiting
      • Toronto Rehabilitation Institute
      • Contact: Urvashy Gopaul, PhD; Phone Number: 7996 416-597-3422; Email: urvashy.gopaul@uhn.ca
      • Sub-Investigator: Urvashy Gopaul, PhD
      • Contact: Olga Yaroslavtseva, BSc; Phone Number: 416-597-3422; Email: olga.yaroslavtseva@uhn.ca
      • Principal Investigator: Mark U Bayley, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: integrated 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).
Active Comparator: Home 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.	Other: Home 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: StrokeCog clinical training platform
• Investigators: Principal Investigator: Mark Bayley, MD, Toronto Rehabilitation Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Ritter PL, Gonzalez VM, Laurent DD, Lorig KR. Measurement of pain using the visual numeric scale. J Rheumatol. 2006 Mar;33(3):574-80.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 22-5628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share the data from this study with any researchers outside this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No