StrokePhase 2Robot3NCT01244243
Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
A Phase 2 study testing Hand & Wrist Assisting Robotic Device in people with Stroke, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Hand & Wrist Assisting Robotic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years old
- Had stroke between 11-26 weeks ago
- Have some weakness in one of your wrists or hands due to stroke
- Did not have too much disability prior to stroke
- Do not have major depression
Who cannot join
- Non-English speaking
- If you have trouble keeping good attention
- Pregnant, advanced liver, kidney, heart, or lung disease
- Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
- Cannot undergo MRI scanning
- Have history of brain surgery or seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.
- Conditions
- Stroke
- Being tested
- Hand & Wrist Assisting Robotic Device
- Keywords
- stroke, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand & Wrist Assisting Robotic DeviceDevice
Also called HWARD
Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks. In each treatment session, you will sit in a chair and have your weak hand attached to a mechanical device (the robot), which will help you open and close your hand. During the treatment, different types of objects (with varying shapes, sizes, and weight) will be placed into your hand. You will be given a variety of instructions related to the grasping, feeling, or identifying of the object in your hand. Sometimes these instructions will be given from the investigator and sometimes from the computer. You will often be asked to grasp, or release, each of these objects as best you can. You will also be asked to concentrate on the object in your hand. An example of what you may be asked to do is to name the object. During other times, you will play games, using the robot to control game parts on the computer screen. At other times, you will move your hand so that the robot can measure your hand function.
| Study group | Role | What they receive |
|---|---|---|
| Active therapy | Experimental | All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment. Receives: Device: Hand & Wrist Assisting Robotic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.
Measured: change from baseline to 1 month post-end treatment, Intention To Treat
Arm Motor Fugl-Meyer Test
The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.
Measured: change from baseline to 1 month post-end treatment, Intention To Treat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 California, IrvineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven C. Cramer, MD, University of California, Irvine
- Investigators
- Steven C Cramer, MD, Principal investigator, University of Californai Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244243
- Sponsor's protocol ID
- HS#2004-3852
- Acronym
- Robot3
- Status last verified
- Aug 2016
- First submitted
- 3 Nov 2010
- Last updated
- 18 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McKenzie A, Dodakian L, See J, Le V, Quinlan EB, Bridgford C, Head D, Han VL, Cramer SC. Validity of Robot-Based Assessments of Upper Extremity Function. Arch Phys Med Rehabil. 2017 Oct;98(10):1969-1976.e2. doi: 10.1016/j.apmr.2017.02.033. Epub 2017 May 5.
PubMed 28483654
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
- ClinicalTrials.gov ID
- NCT01244243
- Acronym / sponsor ID
- Robot3 / HS#2004-3852
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Posted 27 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active therapy | Experimental | Device: Hand & Wrist Assisting Robotic DeviceAll subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Had stroke between 11-26 weeks ago
- Have some weakness in one of your wrists or hands due to stroke
- Did not have too much disability prior to stroke
- Do not have major depression
Key exclusion criteria (6 listed)
- Non-English speaking
- If you have trouble keeping good attention
- Pregnant, advanced liver, kidney, heart, or lung disease
- Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
- Cannot undergo MRI scanning
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 |
|---|---|---|
| Hand & Wrist Assisting Robotic DeviceAlso: HWARDTreatment occurs in 2 hour sessions, 4 times a week over 3 weeks. In each treatment session, you will sit in a chair and have your weak hand attached to a mechanical device (the robot), which will help you open and close your hand. During the treatment, different types of objects (with varying shapes, sizes, and weight) will be placed into your hand. You will be given a variety of instructions related to the grasping, feeling, or identifying of the object in your hand. Sometimes these instructions will be given from the investigator and sometimes from the computer. You will often be asked to grasp, or release, each of these objects as best you can. You will also be asked to concentrate on the object in your hand. An example of what you may be asked to do is to name the object. During other times, you will play games, using the robot to control game parts on the computer screen. At other times, you will move your hand so that the robot can measure your hand function. | Device | Active therapy |
Primary outcome
Action Research Arm Test
Time frame: change from baseline to 1 month post-end treatment, Intention To Treat
The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.
Arm Motor Fugl-Meyer Test
Time frame: change from baseline to 1 month post-end treatment, Intention To Treat
The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28483654McKenzie A, Dodakian L, See J, Le V, Quinlan EB, Bridgford C, Head D, Han VL, Cramer SC. Validity of Robot-Based Assessments of Upper Extremity Function. Arch Phys Med Rehabil. 2017 Oct;98(10):1969-1976.e2. doi: 10.1016/j.apmr.2017.02.033. Epub 2017 May 5.
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.
Steven C Cramer, MD principal investigator
University of Californai Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hand & Wrist Assisting Robotic Device in people with Stroke, run by University of California, Irvine 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 5 inclusion and 6 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 18 Aug 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: change from baseline to 1 month post-end treatment, Intention To Treat). The study lists 2 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 NCT01244243, which also lists 1 linked publication.
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 18 Aug 2016.