Recruiting

Sensation, Motor & Cognition

Sponsor:

University Health Network, Toronto

Code:

NCT06498011

Conditions

Stroke

CVA

Cerebrovascular Accident

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home Graded Repetitive Arm Supplementary Program (GRASP)

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

Study Details

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

Study ID

NCT06498011

Start date

Aug 1, 2024

Status verified date

Dec, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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).

Primary outcome measure

  • Fidelity [ Time Frame: Through study completion, an average of 6 weeks ]
  • Kinarm standard tasks- the Reverse Visually Guided Reaching [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Trail Making A&B [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Object Hit and Avoid [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Spatial Span Task [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Paired Associates Learning [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Visually Guided Reaching [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Object Hit [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Ball-on-Bar [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Arm Posture Perturbation [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Arm Positioning Matching [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Kinarm standard tasks- the Arm Movement Matching [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Fugl-Meyer Assessment-Upper Extremity (FMA-UE) [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Action Research Arm Test (ARAT) [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Grip dynamometry [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Pinch strength [ Time Frame: Baseline, immediately after intervention,1-month ]
  • Box and Block Test (BBT) [ Time Frame: Baseline, immediately after intervention,1-month ]

Central Contacts and Locations

Central contacts

Urvashy Gopaul, PhD

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

Olga Yaroslavtseva, BSc

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

Locations

Toronto Rehabilitation Institute

Recruiting

Toronto, Ontario, Canada, M5G2A1

Contacts

Urvashy Gopaul, PhD

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

Olga Yaroslavtseva, BSc

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

Principal Investigator:

Mark U Bayley, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-12-11.