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NCT Number: NCT06498011

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Rehabilitation Institute

Toronto, Ontario, M5G2A1, Canada

Location status: Recruiting

Location contact

Mark U Bayley, MD

PRINCIPAL_INVESTIGATOR

Olga Yaroslavtseva, BSc

CONTACT

[email protected]

416-597-3422

Urvashy Gopaul, PhD

CONTACT

[email protected]

416-597-3422 ext. 7996

Urvashy Gopaul, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Fidelity

    Time frame: 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.

  2. Kinarm standard tasks- the Reverse Visually Guided Reaching

    Time frame: 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.

  3. Kinarm standard tasks- the Trail Making A&B

    Time frame: 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.

  4. Kinarm standard tasks- the Object Hit and Avoid

    Time frame: 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.

  5. Kinarm standard tasks- the Spatial Span Task

    Time frame: 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.

  6. Kinarm standard tasks- the Paired Associates Learning

    Time frame: 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.

  7. Kinarm standard tasks- the Visually Guided Reaching

    Time frame: 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.

  8. Kinarm standard tasks- the Object Hit

    Time frame: 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.

  9. Kinarm standard tasks- the Ball-on-Bar

    Time frame: 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.

  10. Kinarm standard tasks- the Arm Posture Perturbation

    Time frame: 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.

  11. Kinarm standard tasks- the Arm Positioning Matching

    Time frame: 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.

  12. Kinarm standard tasks- the Arm Movement Matching

    Time frame: 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.

  13. Fugl-Meyer Assessment-Upper Extremity (FMA-UE)

    Time frame: 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.

  14. Action Research Arm Test (ARAT)

    Time frame: 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).

  15. Grip dynamometry

    Time frame: 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.

  16. Pinch strength

    Time frame: Baseline, immediately after intervention,1-month

    Pulp-to-pulp pinch strength will be assessed using a pinch gauge (B & L Engineering).

  17. Box and Block Test (BBT)

    Time frame: Baseline, immediately after intervention,1-month

    The BBT will be used to assess gross manual dexterity.

Secondary outcomes

  1. Stanford Fatigue Visual Analogue Scale (SFVAS)

    Time frame: 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.

  2. Pain visual analogue scale (PVAS)

    Time frame: Through study completion, an average of 6 weeks

    PVAS is a single-item scale ranging from 0 (no pain) to 10 (excruciating pain).

Study contacts

Contact information is provided by the study sponsor or research team.

Olga Yaroslavtseva, BSc

CONTACT

[email protected]

416-597-3422 ext. 7858

Urvashy Gopaul, PhD

CONTACT

[email protected]

416-597-3422 ext. 7996

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • StrokeCog clinical training platform

Registry information

Official study 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)

Acronym: iCOSMO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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