StrokeCARPSSNCT02464085
Characterising Arm Recovery in People With Severe Stroke
An observational study of Stroke, run by University of British Columbia at 1 site in Canada.
Trial summary
The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The investigators will determine 'who recovers', 'who does not recover', and 'why' Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Longitudinal evaluation of recovery
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke survivors with subacute and severe upper limb disability will be evaluated longitudinally.
Who may be able to join
- adults aged 18 to 90 years;
- sustained their first stroke;
- demonstrate subacute (<1 month) and severe upper limb motor deficits (defined by a SAFE [shoulder abduction and finger extension] score of <5 out of 10 points); and
- can follow single stage commands
Who cannot join
- neurological condition other than stroke e.g., Parkinson's disease
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6T1Z3
Kathryn S Hayward, PT PhD, 6048273369, kathryn.hayward@ubc.ca
Lara A Boyd, PT PhD, 6048273369, lara.boyd@ubc.ca
About this study
The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The investigators will determine 'who recovers', 'who does not recover', and 'why'
Read the detailed description
The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The prevalence and severity of stroke related arm disability is increasing and the prospect of optimal recovery is poor. Studies have demonstrated that stroke survivors with severe disability lack early indicators (<7-days to <1-month post-stroke) of a good prognosis, such as active movement at the shoulder and wrist and integrity of the corticospinal tract. This has propagated the clinical belief that this cohort are unlikely to functionally benefit from rehabilitation efforts. However, it is possible that indicators of potential for recovery - either neuroanatomical or clinical - may present in individuals with severe stroke later, that is beyond the early time-period. Indeed, there is increasing evidence of the potential for ongoing improvements in motor performance in response to intensive interventions that are undertaken 6-months or more post-stroke. This therefore, implies that there is some degree of untapped recovery potential. However, as very few studies have longitudinally explored the potential indicators of recovery in a severe cohort, the dynamic capacity of the severely damaged remains unknown. Thus, there is a need to determine 'who recovers', 'who does not recover', and 'why' to be able to promote optimal arm recovery in people with severe impairment after stroke. We will assess stroke survivors <4-weeks, 3-months, 6-months and 12-months post stroke using a range of neuroimaging and clinical outcome measures. The findings from this study will build the foundations for more personalized health care options for people with severe arm impairment post stroke.
- Conditions
- Stroke
- Being tested
- Longitudinal evaluation of recovery
- Keywords
- Stroke, Upper limb, Neuroplastic change, Longitudinal, Function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal evaluation of recoveryOther
Stroke survivors will be assessed at four time frames post stroke to evaluate neuroplastic and clinical changes in arm recovery over the first 12-months post stroke.
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal evaluation of recovery | Stroke survivors with subacute and severe upper limb disability Receives: Other: Longitudinal evaluation of recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3T Magnetic Resonance Imaging (MRI)
Determine the structural and functional connectivity of the brain using diffusion weighted imaging, resting state-functional magnetic resonance imaging and myelin water fraction imaging.
Measured: up to 12-months
Secondary outcomes (13)
Shoulder abduction and finger extension (SAFE)
Measurement of upper limb strength
Measured: 12-months
Fugl-Meyer Assessment (arm and sensory)
Measurement of upper limb impairment
Measured: <4wks, 3-months, 6-months, 12-months
Motor Assessment Scale items 6,7,8
Measurement of upper limb activity
Measured: <4wks, 3-months, 6-months, 12-months
REACH (Rating of Everyday Arm Use in the Community and Home)
Self-report measure of everyday arm use
Measured: <4wks, 3-months, 6-months, 12-months
Accelerometry
Measurement of real world arm use (activity count) over a 7-day period at each time frame
Measured: <4wks, 3-months, 6-months, 12-months
PASS (Postural Assessment Scale for Stroke patients)
Measurement of balance (static and dynamic) and lower limb functional tasks
Measured: <4wks, 3-months, 6-months, 12-months
10-metre walk test
Measurement of walking ability
Measured: <4wks, 3-months, 6-months, 12-months
Montreal Cognitive Assessment (MoCA)
Measurement of cognitive impairment after stroke
Measured: <4wks, 3-months, 6-months, 12-months
Dose of upper limb training
Dose in minutes of passive, active, functional or sensory upper limb tasks performed over a 7-day period at each time frame
Measured: <4wks, 3-months, 6-months, 12-months
National Institute of Stroke Severity Scale
Characterise stroke severity
Measured: <4-weeks
Oxfordshire Bamford Classification
Characterise stroke type
Measured: <4-weeks
Myelin water fraction imaging (WMI)
Determine the myelin content within the brain
Measured: <4wks, 3-months, 6-months, 12-months
Meaningful arm recovery questionnaire
Explore the stroke survivor's perception of meaningful recovery of their upper limb
Measured: <4wks, 3-months, 6-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 of British ColumbiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lara A Boyd, PT PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464085
- Sponsor's protocol ID
- H15-00083
- Acronym
- CARPSS
- Status last verified
- Jan 2017
- First submitted
- 3 Jun 2015
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dahlby J, Larssen BC, Boyd LA. Examining Sex Differences in Relationships Between Subjective and Objective Measures of Upper Extremity Motor Impairment in a Sample of Stroke Survivors. J Neurol Phys Ther. 2024 Jul 1;48(3):159-164. doi: 10.1097/NPT.0000000000000481. Epub 2024 May 20.
PubMed 38768068Hayward KS, Lohse KR, Bernhardt J, Lang CE, Boyd LA. Characterising Arm Recovery in People with Severe Stroke (CARPSS): protocol for a 12-month observational study of clinical, neuroimaging and neurophysiological biomarkers. BMJ Open. 2018 Nov 25;8(11):e026435. doi: 10.1136/bmjopen-2018-026435.
PubMed 30478130
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising Arm Recovery in People With Severe Stroke
- ClinicalTrials.gov ID
- NCT02464085
- Acronym / sponsor ID
- CARPSS / H15-00083
- Conditions
- Stroke
- Keywords
- Stroke, Upper limb, Neuroplastic change, Longitudinal, Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 Jun 2015 (estimated)
- 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 main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The investigators will determine 'who recovers', 'who does not recover', and 'why'
Detailed description
The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The prevalence and severity of stroke related arm disability is increasing and the prospect of optimal recovery is poor. Studies have demonstrated that stroke survivors with severe disability lack early indicators (<7-days to <1-month post-stroke) of a good prognosis, such as active movement at the shoulder and wrist and integrity of the corticospinal tract. This has propagated the clinical belief that this cohort are unlikely to functionally benefit from rehabilitation efforts. However, it is possible that indicators of potential for recovery - either neuroanatomical or clinical - may present in individuals with severe stroke later, that is beyond the early time-period. Indeed, there is increasing evidence of the potential for ongoing improvements in motor performance in response to intensive interventions that are undertaken 6-months or more post-stroke. This therefore, implies that there is some degree of untapped recovery potential. However, as very few studies have longitudinally explored the potential indicators of recovery in a severe cohort, the dynamic capacity of the severely damaged remains unknown. Thus, there is a need to determine 'who recovers', 'who does not recover', and 'why' to be able to promote optimal arm recovery in people with severe impairment after stroke. We will assess stroke survivors <4-weeks, 3-months, 6-months and 12-months post stroke using a range of neuroimaging and clinical outcome measures. The findings from this study will build the foundations for more personalized health care options for people with severe arm impairment post stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal evaluation of recovery | – | Other: Longitudinal evaluation of recoveryStroke survivors with subacute and severe upper limb disability |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke survivors with subacute and severe upper limb disability will be evaluated longitudinally.
Key inclusion criteria (4 listed)
- adults aged 18 to 90 years;
- sustained their first stroke;
- demonstrate subacute (<1 month) and severe upper limb motor deficits (defined by a SAFE [shoulder abduction and finger extension] score of <5 out of 10 points); and
- can follow single stage commands
Key exclusion criteria (1 listed)
- neurological condition other than stroke e.g., Parkinson's disease
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 |
|---|---|---|
| Longitudinal evaluation of recoveryStroke survivors will be assessed at four time frames post stroke to evaluate neuroplastic and clinical changes in arm recovery over the first 12-months post stroke. | Other | Longitudinal evaluation of recovery |
Primary outcome
3T Magnetic Resonance Imaging (MRI)
Time frame: up to 12-months
Determine the structural and functional connectivity of the brain using diffusion weighted imaging, resting state-functional magnetic resonance imaging and myelin water fraction imaging.
13 secondary outcomes
Shoulder abduction and finger extension (SAFE)
Time frame: 12-months
Fugl-Meyer Assessment (arm and sensory)
Time frame: <4wks, 3-months, 6-months, 12-months
Motor Assessment Scale items 6,7,8
Time frame: <4wks, 3-months, 6-months, 12-months
REACH (Rating of Everyday Arm Use in the Community and Home)
Time frame: <4wks, 3-months, 6-months, 12-months
Accelerometry
Time frame: <4wks, 3-months, 6-months, 12-months
PASS (Postural Assessment Scale for Stroke patients)
Time frame: <4wks, 3-months, 6-months, 12-months
10-metre walk test
Time frame: <4wks, 3-months, 6-months, 12-months
Montreal Cognitive Assessment (MoCA)
Time frame: <4wks, 3-months, 6-months, 12-months
Dose of upper limb training
Time frame: <4wks, 3-months, 6-months, 12-months
National Institute of Stroke Severity Scale
Time frame: <4-weeks
Oxfordshire Bamford Classification
Time frame: <4-weeks
Myelin water fraction imaging (WMI)
Time frame: <4wks, 3-months, 6-months, 12-months
Meaningful arm recovery questionnaire
Time frame: <4wks, 3-months, 6-months, 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Derived from this study: PubMed 38768068Dahlby J, Larssen BC, Boyd LA. Examining Sex Differences in Relationships Between Subjective and Objective Measures of Upper Extremity Motor Impairment in a Sample of Stroke Survivors. J Neurol Phys Ther. 2024 Jul 1;48(3):159-164. doi: 10.1097/NPT.0000000000000481. Epub 2024 May 20.
- Derived from this study: PubMed 30478130Hayward KS, Lohse KR, Bernhardt J, Lang CE, Boyd LA. Characterising Arm Recovery in People with Severe Stroke (CARPSS): protocol for a 12-month observational study of clinical, neuroimaging and neurophysiological biomarkers. BMJ Open. 2018 Nov 25;8(11):e026435. doi: 10.1136/bmjopen-2018-026435.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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. This study is not recruiting at the moment.
Lara A Boyd, PT PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of British Columbia 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 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn S Hayward, PT PhD (6048273369, kathryn.hayward@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3T Magnetic Resonance Imaging (MRI) (time frame: up to 12-months). 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 NCT02464085, which also lists 2 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 10 Jan 2017.