StrokeSMARTS2NCT02292251
Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
A study testing Device-assisted therapy and Therapy-based occupational therapy in people with Stroke, run by Johns Hopkins University at 3 sites in 2 countries.
Trial summary
Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Device-assisted therapy and Therapy-based occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2015to Apr 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 21 years
- Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
- No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
- Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
- Ability to give informed consent and understand the tasks involved.
Who cannot join
- Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
- Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
- Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
- Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
- History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
- Inability to sit in a chair and perform upper limb exercises for one hour at a time.
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- Participation in another upper extremity rehabilitative therapy study during the study period.
- Terminal illness
- Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Columbia University
New York, New York, 10032
About this study
Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.
- Conditions
- Stroke
- Being tested
- Device-assisted therapy, Therapy-based occupational therapy
- Keywords
- Stroke, Transcranial direct current stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device-assisted therapyBehavioural
Therapy-based occupational therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Device-assisted therapy | Active comparator | 30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation Receives: Behavioral: Device-assisted therapy |
| Therapy-based occupational therapy | Active comparator | 30 hours of conventional occupational therapy that emphasizes task-oriented training. Receives: Behavioral: Therapy-based occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity (FM-UE)
Change in arm impairment, measured by FM-UE
Measured: from baseline to day 3 post-training
Secondary outcomes (1)
Fugl-Meyer Upper Extremity (FM-UE)
Change in arm impairment, measured by FM-UE
Measured: from baseline to day 90 post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startMay 2015
- Primary completionNov 2017
- Study completionApr 2018
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 Johns Hopkins UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, University of Zurich, James S McDonnell Foundation
- Responsible party
- Sponsor
- Investigators
- John W. Krakauer, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292251
- Sponsor's protocol ID
- IRB00047647
- Acronym
- SMARTS2
- Status last verified
- Aug 2018
- First submitted
- 8 Nov 2014
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Krakauer JW, Kitago T, Goldsmith J, Ahmad O, Roy P, Stein J, Bishop L, Casey K, Valladares B, Harran MD, Cortes JC, Forrence A, Xu J, DeLuzio S, Held JP, Schwarz A, Steiner L, Widmer M, Jordan K, Ludwig D, Moore M, Barbera M, Vora I, Stockley R, Celnik P, Zeiler S, Branscheidt M, Kwakkel G, Luft AR. Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. Neurorehabil Neural Repair. 2021 May;35(5):393-405. doi: 10.1177/15459683211000730. Epub 2021 Mar 20.
PubMed 33745372Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
- ClinicalTrials.gov ID
- NCT02292251
- Acronym / sponsor ID
- SMARTS2 / IRB00047647
- Conditions
- Stroke
- Keywords
- Stroke, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Columbia University, University of Zurich, James S McDonnell Foundation
- Study start
- May 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 17 Nov 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.
Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device-assisted therapy | Active comparator | Behavioral: Device-assisted therapy30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation |
| Therapy-based occupational therapy | Active comparator | Behavioral: Therapy-based occupational therapy30 hours of conventional occupational therapy that emphasizes task-oriented training. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 21 years
- Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
- No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
- Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
- Ability to give informed consent and understand the tasks involved.
Key exclusion criteria (9 listed)
- Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
- Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
- Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
- Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
- History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, 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 |
|---|---|---|
| Device-assisted therapy | Behavioural | Device-assisted therapy |
| Therapy-based occupational therapy | Behavioural | Therapy-based occupational therapy |
Primary outcome
Fugl-Meyer Upper Extremity (FM-UE)
Time frame: from baseline to day 3 post-training
Change in arm impairment, measured by FM-UE
1 secondary outcome
Fugl-Meyer Upper Extremity (FM-UE)
Time frame: from baseline to day 90 post-training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Derived from this study: PubMed 33745372Krakauer JW, Kitago T, Goldsmith J, Ahmad O, Roy P, Stein J, Bishop L, Casey K, Valladares B, Harran MD, Cortes JC, Forrence A, Xu J, DeLuzio S, Held JP, Schwarz A, Steiner L, Widmer M, Jordan K, Ludwig D, Moore M, Barbera M, Vora I, Stockley R, Celnik P, Zeiler S, Branscheidt M, Kwakkel G, Luft AR. Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. Neurorehabil Neural Repair. 2021 May;35(5):393-405. doi: 10.1177/15459683211000730. Epub 2021 Mar 20.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
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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.
John W. Krakauer, MD principal investigator
Johns Hopkins University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device-assisted therapy and Therapy-based occupational therapy in people with Stroke, run by Johns Hopkins University at 3 sites in 2 countries.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fugl-Meyer Upper Extremity (FM-UE) (time frame: from baseline to day 3 post-training). 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 NCT02292251, 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 Aug 2018.