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

University Health Network, Toronto

Status: Enrolling

Conditions: Cerebrovascular Accident; Stroke; CVA

Treatments: Other: integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO); Other: Home Graded Repetitive Arm Supplementary Program (GRASP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06498011

22-5628

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

iCOSMO

Experimental group

Description:

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.

Treatment:

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

Home GRASP

Active Comparator group

Description:

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.

Treatment:

Other: Home Graded Repetitive Arm Supplementary Program (GRASP)