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

NCT06498011 | Recruiting

• 1 other identifier: 22-5628
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; CVA; Cerebrovascular Accident

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (2)

• Stanford Fatigue Visual Analogue Scale (SFVAS)

  Through study completion, an average of 6 weeks

• Pain visual analogue scale (PVAS)

  Through study completion, an average of 6 weeks

Study Arms (2)

iCOSMO

EXPERIMENTAL

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)

Home GRASP

ACTIVE COMPARATOR

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)

Interventions

Home Graded Repetitive Arm Supplementary Program (GRASP) OTHER

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.

Home GRASP

integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO) OTHER

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).

iCOSMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• StrokeCog clinical training platform: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5G2A1, Canada

RECRUITING

Related Publications (7)

• 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.

  PMID: 30230136 BACKGROUND

• 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.

  PMID: 20424192 BACKGROUND

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

  PMID: 16511926 BACKGROUND

• 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.

  PMID: 27724945 BACKGROUND

• 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.

  PMID: 6622535 BACKGROUND

• 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.

  PMID: 27145212 BACKGROUND

• 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.

  PMID: 3160243 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mark Bayley, MD

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urvashy Gopaul, PhD

CONTACT

416-597-3422; urvashy.gopaul@uhn.ca

Olga Yaroslavtseva, BSc

CONTACT

416-597-3422; olga.yaroslavtseva@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 12, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)