StrokePhase 2NCT00995774
Extension of the MIME Robotic System for Stroke Rehabilitation
A Phase 2 study testing robotic therapy and conventional functional training in people with Stroke and Impaired Upper Extremity Function, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The goal of this project is to develop and test a new robotic system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME robot is safe and effective for improving reach in stroke subjects. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke, Impaired Upper Extremity Function
- What is being tested?
- robotic therapy and conventional functional training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study;
- trace ability to move the wrist and fingers in extension;
- voluntary shoulder elevation to approximately 45 deg;
- be between the ages of 21 and 90.
Who cannot join
- Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State Examination (Bleeker, 1988);
- have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols;
- have an upper extremity injury or conditions prior to stroke that could limit participation;
- have severe hemispatial neglect.
- have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and
- have severe sensory loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, DC
Washington D.C., District of Columbia, 20422
About this study
The goal of this project is to develop and test a new robotic system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME robot is safe and effective for improving reach in stroke subjects. But adequate control of hand movements is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent study, 38% of stroke survivors reported that impaired hand function was the most disabling motor impairment they faced.
Read the detailed description
Research Design:
We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after robotic training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after robotic training will be greater than after dose-matched conventional therapy.
Methodology:
In the first year of the study, we will develop a robotic system with the ability to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the ARMin III arm exoskeleton so that tasks such as arm reach, grasp of an object and release of the object can be trained. In the last 2 years of the project, we will perform a pilot clinical trial comparing this new training paradigm to dose-matched conventional therapy in chronic stroke survivors. Outcome measures will be taken before training and immediately after training.
- Conditions
- Stroke, Impaired Upper Extremity Function
- Being tested
- robotic therapy, conventional functional training
- Keywords
- stroke, function, arm, hand, robotic, therapy, motor, movement, treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic therapyDevice
12 sessions of robot therapy for arm and hand function
conventional functional trainingOther
12 sessions of conventional therapy for the arm and hand from a physical therapist
robotic therapyDevice
12 sessions of robot therapy for arm and hand function
conventional functional trainingOther
12 sessions of conventional therapy for the arm and hand from a physical therapist
| Study group | Role | What they receive |
|---|---|---|
| Robotic then Conventional | Experimental | robotic arm therapy first, conventional therapy second Receives: Device: robotic therapy; Other: conventional functional training |
| Conventional then Robotic | Experimental | conventional therapy first, robotic therapy second Receives: Device: robotic therapy; Other: conventional functional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Test of Motor Function
This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.
Measured: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
Secondary outcomes (2)
Action Research Arm Test
This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.
Measured: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).
Measured: pre-treatment, post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionMay 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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter S. Lum, PhD, Principal investigator, VA Medical Center, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995774
- Sponsor's protocol ID
- B4719-R
- Status last verified
- Aug 2018
- First submitted
- 8 Oct 2009
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brokaw EB, Nichols D, Holley RJ, Lum PS. Robotic therapy provides a stimulus for upper limb motor recovery after stroke that is complementary to and distinct from conventional therapy. Neurorehabil Neural Repair. 2014 May;28(4):367-76. doi: 10.1177/1545968313510974. Epub 2013 Dec 2.
PubMed 24297763
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension of the MIME Robotic System for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT00995774
- Acronym / sponsor ID
- B4719-R
- Conditions
- Stroke, Impaired Upper Extremity Function
- Keywords
- stroke, function, arm, hand, robotic, therapy, motor, movement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Posted 14 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to develop and test a new robotic system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME robot is safe and effective for improving reach in stroke subjects. But adequate control of hand movements is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent study, 38% of stroke survivors reported that impaired hand function was the most disabling motor impairment they faced.
Detailed description
Research Design:
We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after robotic training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after robotic training will be greater than after dose-matched conventional therapy.
Methodology:
In the first year of the study, we will develop a robotic system with the ability to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the ARMin III arm exoskeleton so that tasks such as arm reach, grasp of an object and release of the object can be trained. In the last 2 years of the project, we will perform a pilot clinical trial comparing this new training paradigm to dose-matched conventional therapy in chronic stroke survivors. Outcome measures will be taken before training and immediately after training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic then Conventional | Experimental | Device: robotic therapy, Other: conventional functional trainingrobotic arm therapy first, conventional therapy second |
| Conventional then Robotic | Experimental | Device: robotic therapy, Other: conventional functional trainingconventional therapy first, robotic therapy second |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study;
- trace ability to move the wrist and fingers in extension;
- voluntary shoulder elevation to approximately 45 deg;
- be between the ages of 21 and 90.
Key exclusion criteria (6 listed)
- Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State Examination (Bleeker, 1988);
- have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols;
- have an upper extremity injury or conditions prior to stroke that could limit participation;
- have severe hemispatial neglect.
- have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and
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 |
|---|---|---|
| robotic therapy12 sessions of robot therapy for arm and hand function | Device | Robotic then Conventional |
| conventional functional training12 sessions of conventional therapy for the arm and hand from a physical therapist | Other | Robotic then Conventional |
| robotic therapy12 sessions of robot therapy for arm and hand function | Device | Conventional then Robotic |
| conventional functional training12 sessions of conventional therapy for the arm and hand from a physical therapist | Other | Conventional then Robotic |
Primary outcome
Fugl-Meyer Test of Motor Function
Time frame: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.
2 secondary outcomes
Action Research Arm Test
Time frame: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).
Time frame: pre-treatment, post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24297763Brokaw EB, Nichols D, Holley RJ, Lum PS. Robotic therapy provides a stimulus for upper limb motor recovery after stroke that is complementary to and distinct from conventional therapy. Neurorehabil Neural Repair. 2014 May;28(4):367-76. doi: 10.1177/1545968313510974. Epub 2013 Dec 2.
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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.
Peter S. Lum, PhD principal investigator
VA Medical Center, DC
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 robotic therapy and conventional functional training in people with Stroke and Impaired Upper Extremity Function, run by US Department of Veterans Affairs 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 4 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 20 Sep 2018. 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 14 Feb 2014). 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?
Fugl-Meyer Test of Motor Function (time frame: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2). 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 NCT00995774, 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 20 Sep 2018.