StrokeCPASSNCT02235974
Critical Periods After Stroke Study (CPASS)
A study testing Early Intensive upper extremity motor training, Sub-acute intensive upper extremity motor training and Chronic intensive upper extremity motor training in people with Stroke and Brain Infarction, run by MedStar National Rehabilitation Network at 1 site in United States.
Trial summary
To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Brain Infarction, Brain Ischemia
- What is being tested?
- Early Intensive upper extremity motor training, Sub-acute intensive upper extremity motor training and Chronic intensive upper extremity motor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2014to 31 Jan 2021
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 days of admission to inpatient rehabilitation (allows those randomized to the early arm to begin study-related treatment within 30 days)
- Age >21 years
- Able to participate in first study-related treatment session within 30 days of stroke onset
- Able to participate in all study-related activities, including one year follow up and blood draws
- Persistent hemiparesis leading to impaired upper extremity function. Hemiparesis as indicated by NIHSS Motor Arm score ≥ 1
- Recovering moderate motor impairment at the shoulder and elbow or hand such as:
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- Proximal UE voluntary activity indicated by a score of ≥ 3 on the upper arm item of the Motor Assessment Scale - wrist and finger movement is not required
- or
- Manual Muscle Test (MMT) score of ≥ 2 on shoulder flexion or abduction and MMT score of ≥ 2 for any of the following: elbow flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger extension.
- or
- Active range of motion (AROM) to at least 50% of range in gravity eliminated position for shoulder flexion or abduction, and for any of the following motions: elbow flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger extension.
- Score of ≤ 8 on the Short Blessed Memory Orientation and Concentration Scale
- Follows 2 step commands
- No upper extremity injury or conditions that limited use prior to the stroke
- Pre-stroke independence: Modified Rankin Score 0 or 1
Who cannot join
- Inability to give informed consent
- Prior stroke with persistent motor impairment or other disabling neurologic condition such as multiple sclerosis, parkinsonism, amyotrophic lateral sclerosis (ALS), dementia requiring medication
- Rapidly improving motor function
- Clinically significant fluctuations in mental status in the 72 hours prior to randomization
- Hemispatial neglect as determined by >3 errors on the Mesulam Symbol Cancellation Test
- Not independent prior to stroke (determined by scores of <95 on Barthel Index or >1 on Modified Rankin Scale
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- Dense sensory loss indicated by a score of 2 on NIHSS sensory item
- Ataxia out of proportion to weakness in the affected arm as described by a score of ≥ 1 on the NIHSS limb ataxia item
- Active or prior psychosis within 2 years
- Active or prior (within 2 years) substance abuse
- Not expected to survive 1 year due to other illnesses (cardiac disease, malignancy, etc)
- Received upper extremity botulinum toxin within 6 months (other medications do not exclude)
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Critical Periods After Stroke Study (CPASS); Sensitive Periods and Consumer Preferences: Optimizing Upper Extremity Stroke Rehabilitation
To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training. The investigators will perform a prospective exploratory study of upper extremity (UE) motor training delivered at higher than usual intensity at three different time points after stroke:
- early (initiated within 30 days)
- subacute/outpatient (initiated within 2-3 months)
- chronic (initiated within 6-9 months)
Read more
The control group will not receive the therapy intervention during the 1-year study.
Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and one year after stroke onset.
Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or chronic (6-9 months after stroke onset) time points, participants randomized to early intensive motor training will show greater upper extremity motor improvement measured at one year post stroke.
Read the detailed description
Please see the following reference:
Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan, E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M., Fiandaca, M.S., Federoff, H.J., \& Newport, E.L. (2015). Critical Periods after Stroke Study: Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human Neuroscience, 9, 002231. PMCID: PMC4413691.
- Being tested
- Early Intensive upper extremity motor training, Sub-acute intensive upper extremity motor training, Chronic intensive upper extremity motor training, Control
- Keywords
- stroke, critical periods, sensitive periods, hemiparesis, upper extremity, physical rehabilitation, arm therapy, occupational therapy, physical therapy, task oriented training, patient focused, arm function, hand function, neurorehabilitation, motor learning, motor control, motor function, motor recovery, skill acquisition, skill training
- Medical subject headings
- Stroke, Brain Infarction, Brain Ischemia, Cerebral Infarction, Cerebrovascular Disorders, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Intensive upper extremity motor trainingBehavioural
Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 30 days of stroke onset.
Sub-acute intensive upper extremity motor trainingBehavioural
Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 2 to 3 months post stroke.
Chronic intensive upper extremity motor trainingBehavioural
Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 6 to 9 months post stroke.
ControlBehavioural
Usual and Customary Care only. No additional therapy will be given during the 1-year study.
| Study group | Role | What they receive |
|---|---|---|
| Acute/Early | Experimental | Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke. Receives: Behavioral: Early Intensive upper extremity motor training |
| Sub-acute/Outpatient | Experimental | Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke. Receives: Behavioral: Sub-acute intensive upper extremity motor training |
| Chronic | Experimental | Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke Receives: Behavioral: Chronic intensive upper extremity motor training |
| Control | Placebo comparator | Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity.
Measured: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Secondary outcomes (17)
Motor Activity Log - 28 Quality of Movement (MAL-28 QOM)
A structured interview to measure upper extremity use and function as well as assess the quality of movement of the hemiparetic arm.
Measured: Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Nine Hole Peg Test (9-HPT)
A standardized quantitative test of upper extremity function and fine manual dexterity.
Measured: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Functional Independence Measure (FIM)
A basic indicator of severity of disability. Tracks changes in the functional ability of the patient during an episode of hospital rehabilitation care.
Measured: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Barthel Index (BI)
Measures performance in activities of daily living and functional disability.
Measured: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Motricity Index - Arm only (MI)
To assess motor impairment and strength in the upper extremity.
Measured: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Perception of change (POC)
A stroke-specific self-report to assess how stroke has impacted a person's life and their overall perception of recovery.
Measured: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Stroke Impact Scale - Hand-Arm subscale (SIS)
A self-report health status measure to assess perceived recovery with regard to the more affected hand and arm following a stroke.
Measured: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Modified Rankin Scale (MRS)
A measure of the degree of disability or dependence in daily activities following a stroke.
Measured: Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Activity Card Sort (ACS)
An interview-based assessment used to measure an individual's participation in instrumental, leisure and social activities.
Measured: Pre-treatment (ideally within 72 hours of baseline), post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Reintegration to Normal Living Index (RNLI)
To assess quantitatively the degree that individuals who have experienced a traumatic injury or illness come to manage and reintegrate normal social activities with regard to recreation, movement at home and within the community, family and relationships.
Measured: Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke
Geriatric Depression Scale (GDS-15)
A self-report assessment used to identify depressive symptoms in the elderly.
Measured: Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke
NIH Stroke Scale (NIHSS)
A systematic assessment used to evaluate and measure stroke-related. neurological impairments and stroke severity.
Measured: Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke
Short Blessed Orientation and Memory Concentration Test (SBT)
An assessment of cognitive ability and impairment.
Measured: Baseline (within 30 days post stroke)
Mesulam Symbol Cancellation Test (SCT)
An assessment used to evaluate visuospatial function and attention.
Measured: Baseline (within 30 days post stroke)
Faces Pain Scale
A self-report measure of pain intensity.
Measured: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Fugl Meyer Assessment (Upper Extremity)
A performanced-based impairment index to assess motor function, sensation and joint function.
Measured: Baseline (within 30 days post stroke) and 1 year post stroke
Manual Muscle Test (Upper Extremity)
Muscle strength assessment
Measured: Baseline (within 30 days post stroke)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study start26 Aug 2014
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedStar National Rehabilitation Network
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University, University of Wisconsin, Madison, The Catholic University of America, Medstar Health Research Institute
- Responsible party
- Principal investigator, Alexander W. Dromerick, MD, MedStar National Rehabilitation Network
- Investigators
- Alexander W Dromerick, MD, Principal investigator, MedStar National Rehabilitation Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235974
- Sponsor's protocol ID
- MNRH-2014-065
- Acronym
- CPASS
- Status last verified
- Apr 2020
- First submitted
- 14 Jul 2014
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan at this time to make individual participant data available.
Publications
Dromerick AW, Edwardson MA, Edwards DF, Giannetti ML, Barth J, Brady KP, Chan E, Tan MT, Tamboli I, Chia R, Orquiza M, Padilla RM, Cheema AK, Mapstone ME, Fiandaca MS, Federoff HJ, Newport EL. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial. Front Hum Neurosci. 2015 Apr 29;9:231. doi: 10.3389/fnhum.2015.00231. eCollection 2015.
PubMed 25972803Geed S, Feit P, Edwards DF, Dromerick AW. Why Are Stroke Rehabilitation Trial Recruitment Rates in Single Digits? Front Neurol. 2021 Jun 8;12:674237. doi: 10.3389/fneur.2021.674237. eCollection 2021.
PubMed 34168611
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Periods After Stroke Study (CPASS); Sensitive Periods and Consumer Preferences: Optimizing Upper Extremity Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT02235974
- Acronym / sponsor ID
- CPASS / MNRH-2014-065
- Keywords
- stroke, critical periods, sensitive periods, hemiparesis, upper extremity, physical rehabilitation, arm therapy, occupational therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MedStar National Rehabilitation NetworkUniversity, hospital or other
- Collaborators
- Georgetown University, University of Wisconsin, Madison, The Catholic University of America, Medstar Health Research Institute
- Study start
- 26 Aug 2014 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 10 Sep 2014 (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.
To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training. The investigators will perform a prospective exploratory study of upper extremity (UE) motor training delivered at higher than usual intensity at three different time points after stroke:
- early (initiated within 30 days)
- subacute/outpatient (initiated within 2-3 months)
- chronic (initiated within 6-9 months)
The control group will not receive the therapy intervention during the 1-year study.
Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and one year after stroke onset.
Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or chronic (6-9 months after stroke onset) time points, participants randomized to early intensive motor training will show greater upper extremity motor improvement measured at one year post stroke.
Detailed description
Please see the following reference:
Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan, E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M., Fiandaca, M.S., Federoff, H.J., \& Newport, E.L. (2015). Critical Periods after Stroke Study: Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human Neuroscience, 9, 002231. PMCID: PMC4413691.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute/Early | Experimental | Behavioral: Early Intensive upper extremity motor trainingIntervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke. |
| Sub-acute/Outpatient | Experimental | Behavioral: Sub-acute intensive upper extremity motor trainingIntervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke. |
| Chronic | Experimental | Behavioral: Chronic intensive upper extremity motor trainingIntervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke |
| Control | Placebo comparator | Behavioral: ControlIntervention: Usual and customary care. No additional therapy will be initiated during the 1-year study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 days of admission to inpatient rehabilitation (allows those randomized to the early arm to begin study-related treatment within 30 days)
- Age >21 years
- Able to participate in first study-related treatment session within 30 days of stroke onset
- Able to participate in all study-related activities, including one year follow up and blood draws
- Persistent hemiparesis leading to impaired upper extremity function. Hemiparesis as indicated by NIHSS Motor Arm score ≥ 1
Key exclusion criteria (12 listed)
- Inability to give informed consent
- Prior stroke with persistent motor impairment or other disabling neurologic condition such as multiple sclerosis, parkinsonism, amyotrophic lateral sclerosis (ALS), dementia requiring medication
- Rapidly improving motor function
- Clinically significant fluctuations in mental status in the 72 hours prior to randomization
- Hemispatial neglect as determined by >3 errors on the Mesulam Symbol Cancellation Test
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 |
|---|---|---|
| Early Intensive upper extremity motor trainingUsing a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 30 days of stroke onset. | Behavioural | Acute/Early |
| Sub-acute intensive upper extremity motor trainingUsing a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 2 to 3 months post stroke. | Behavioural | Sub-acute/Outpatient |
| Chronic intensive upper extremity motor trainingUsing a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 6 to 9 months post stroke. | Behavioural | Chronic |
| ControlUsual and Customary Care only. No additional therapy will be given during the 1-year study. | Behavioural | Control |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity.
17 secondary outcomes
Motor Activity Log - 28 Quality of Movement (MAL-28 QOM)
Time frame: Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Nine Hole Peg Test (9-HPT)
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Functional Independence Measure (FIM)
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Barthel Index (BI)
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Motricity Index - Arm only (MI)
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Perception of change (POC)
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Stroke Impact Scale - Hand-Arm subscale (SIS)
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Modified Rankin Scale (MRS)
Time frame: Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Activity Card Sort (ACS)
Time frame: Pre-treatment (ideally within 72 hours of baseline), post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Reintegration to Normal Living Index (RNLI)
Time frame: Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke
Geriatric Depression Scale (GDS-15)
Time frame: Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke
NIH Stroke Scale (NIHSS)
Time frame: Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke
Short Blessed Orientation and Memory Concentration Test (SBT)
Time frame: Baseline (within 30 days post stroke)
Mesulam Symbol Cancellation Test (SCT)
Time frame: Baseline (within 30 days post stroke)
Faces Pain Scale
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Fugl Meyer Assessment (Upper Extremity)
Time frame: Baseline (within 30 days post stroke) and 1 year post stroke
Manual Muscle Test (Upper Extremity)
Time frame: Baseline (within 30 days post stroke)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Background: PubMed 25972803Dromerick AW, Edwardson MA, Edwards DF, Giannetti ML, Barth J, Brady KP, Chan E, Tan MT, Tamboli I, Chia R, Orquiza M, Padilla RM, Cheema AK, Mapstone ME, Fiandaca MS, Federoff HJ, Newport EL. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial. Front Hum Neurosci. 2015 Apr 29;9:231. doi: 10.3389/fnhum.2015.00231. eCollection 2015.
- Derived from this study: PubMed 34168611Geed S, Feit P, Edwards DF, Dromerick AW. Why Are Stroke Rehabilitation Trial Recruitment Rates in Single Digits? Front Neurol. 2021 Jun 8;12:674237. doi: 10.3389/fneur.2021.674237. eCollection 2021.
- Individual participant dataSharing planned: No. There is no plan at this time to make individual participant data available.
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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.
Alexander W Dromerick, MD principal investigator
MedStar National Rehabilitation Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Intensive upper extremity motor training, Sub-acute intensive upper extremity motor training and Chronic intensive upper extremity motor training in people with Stroke and Brain Infarction, run by MedStar National Rehabilitation Network at 1 site in United States.
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 15 inclusion and 12 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 7 Apr 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke). 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 NCT02235974, 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 7 Apr 2020.