StrokeiCOSMONCT06498011
COgnitive-somatoSensory-MOtor Training to Improve Arm and Hand Function After Stroke (iCOSMO)
A study testing Home Graded Repetitive Arm Supplementary Program (GRASP) and integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO) in people with Stroke and CVA, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, CVA, Cerebrovascular Accident
- What is being tested?
- Home Graded Repetitive Arm Supplementary Program (GRASP) and integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institute
Toronto, Ontario, M5G2A1
Urvashy Gopaul, PhD, 416-597-3422 ext. 7996, urvashy.gopaul@uhn.ca
Olga Yaroslavtseva, BSc, 416-597-3422, olga.yaroslavtseva@uhn.ca
About this study
Official 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)
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.
Read the detailed 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.
- Conditions
- Stroke, CVA, Cerebrovascular Accident
- Being tested
- Home Graded Repetitive Arm Supplementary Program (GRASP), integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Home Graded Repetitive Arm Supplementary Program (GRASP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity
Measures of fidelity will monitor intervention delivery such as the number of intervention sessions attended and the amount of practice.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, immediately after intervention,1-month
Pinch strength
Pulp-to-pulp pinch strength will be assessed using a pinch gauge (B \& L Engineering).
Measured: Baseline, immediately after intervention,1-month
Box and Block Test (BBT)
The BBT will be used to assess gross manual dexterity.
Measured: Baseline, immediately after intervention,1-month
Secondary outcomes (2)
Stanford Fatigue Visual Analogue Scale (SFVAS)
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.
Measured: Through study completion, an average of 6 weeks
Pain visual analogue scale (PVAS)
PVAS is a single-item scale ranging from 0 (no pain) to 10 (excruciating pain).
Measured: Through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- StrokeCog clinical training platform
- Responsible party
- Principal investigator, Mark Bayley, University Health Network, Toronto
- Investigators
- Mark Bayley, MD, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498011
- Sponsor's protocol ID
- 22-5628
- Acronym
- iCOSMO
- Status last verified
- Dec 2024
- First submitted
- 24 Jun 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share the data from this study with any researchers outside this study.
Publications
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.
PubMed 30230136Birkenmeier 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.
PubMed 20424192Ritter PL, Gonzalez VM, Laurent DD, Lorig KR. Measurement of pain using the visual numeric scale. J Rheumatol. 2006 Mar;33(3):574-80.
PubMed 16511926Bourke 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.
PubMed 27724945Duncan 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.
PubMed 6622535Ekstrand 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.
PubMed 27145212Mathiowetz 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.
PubMed 3160243
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06498011
- Acronym / sponsor ID
- iCOSMO / 22-5628
- Conditions
- Stroke, CVA, Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- StrokeCog clinical training platform
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCOSMO | Experimental | Other: integrated Somatosensory-MOtor training using a COgnitive approach(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. |
| Home GRASP | Active comparator | Other: Home Graded Repetitive Arm Supplementary Program (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Home GRASP |
| 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). | Other | iCOSMO |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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).
Box and Block Test (BBT)
Time frame: Baseline, immediately after intervention,1-month
The BBT will be used to assess gross manual dexterity.
2 secondary outcomes
Stanford Fatigue Visual Analogue Scale (SFVAS)
Time frame: Through study completion, an average of 6 weeks
Pain visual analogue scale (PVAS)
Time frame: Through study completion, an average of 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 30230136Gopaul 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.
- Background: PubMed 20424192Birkenmeier 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.
- Background: PubMed 16511926Ritter PL, Gonzalez VM, Laurent DD, Lorig KR. Measurement of pain using the visual numeric scale. J Rheumatol. 2006 Mar;33(3):574-80.
- Background: PubMed 27724945Bourke 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.
- Background: PubMed 6622535Duncan 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.
- Background: PubMed 27145212Ekstrand 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.
- Background: PubMed 3160243Mathiowetz 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.
- Individual participant dataSharing planned: No. We do not plan to share the data from this study with any researchers outside this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Bayley, MD principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Graded Repetitive Arm Supplementary Program (GRASP) and integrated Somatosensory-MOtor training using a COgnitive approach(iCOSMO) in people with Stroke and CVA, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Urvashy Gopaul, PhD (416-597-3422 ext. 7996, urvashy.gopaul@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity (time frame: Through study completion, an average of 6 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06498011, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.