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Behavioural Intervention

Cognitive-Somatosensory-Motor Training for Stroke (iCOSMO Trial)

N/A

Recruiting

Led By Mark Bayley, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of motor and/or somatosensory deficits in the upper limbs

Clinical diagnosis of stroke

Must not have

Prior history of central nervous system dysfunction other than stroke

Upper limb deficits resulting from non-stroke pathology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately after intervention,1-month

Awards & highlights

No Placebo-Only Group

Summary

"This trial is looking at whether a new intervention that combines sensation, movement, and thinking can help improve arm and hand function in people who have had a stroke a long time ago."

Who is the study for?

The iCOSMO trial is for individuals who have had a stroke and are looking to improve the function of their arm and hand. Specific eligibility criteria details were not provided.

What is being tested?

This study tests two types of training programs: GRASP, which patients do at home, and iCOSMO, which integrates sensory, motor, and cognitive exercises to aid recovery after a chronic stroke.

What are the potential side effects?

Potential side effects are not detailed in the information provided but may include muscle soreness or fatigue due to exercise-based interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have weakness or sensory loss in my arms.

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I have been diagnosed with a stroke.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a brain disorder other than a stroke.

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I have arm or hand issues not caused by a stroke.

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I can follow instructions and provide consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately after intervention,1-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately after intervention,1-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after intervention,1-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Action Research Arm Test (ARAT)

Box and Block Test (BBT)

Fidelity

+14 more

Secondary study objectives

Pain visual analogue scale (PVAS)

Stanford Fatigue Visual Analogue Scale (SFVAS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iCOSMOExperimental Treatment1 Intervention

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.

Group II: Home GRASPActive Control1 Intervention

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.

0 / 6Eligibility criteria met