Cerebral StrokeNCT00237744
Brain and Coordination Changes Induced By Robotics and FES Treatment Following Stroke
A study testing Robotics training for shoulder elbow., Surface Functional Neuromuscular Stimulation and whole arm motor learning in people with Cerebral Stroke and Cerebrovascular Accident, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. This study will compare treatment response to robotics versus functional neuromuscular stimulation. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Stroke, Cerebrovascular Accident, Stroke
- What is being tested?
- Robotics training for shoulder elbow., Surface Functional Neuromuscular Stimulation and whole arm motor learning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Sep 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medically stable and at least 12 months post stroke.
- Difficulty using upper limb for functional tasks.
- Age >21 years
Who cannot join
- uncontrolled, chronic medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CNS Plasticity Induced By Motor Learning Technologies Following Stroke
The long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. This study will compare treatment response to robotics versus functional neuromuscular stimulation.
Read the detailed description
Methods. Up to ninety-six chronic stroke subjects (> 12 months post stroke) will be randomized to one of the treatment groups: Wrist/hand Functional Electrical Stimulation (FES)+whole arm motor learning group; shoulder/elbow robotics + whole arm motor learning group; and whole arm motor learning group. For all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. All three treatment groups will receive motor learning therapy. For the Wrist/hand FES+whole arm motor learning group, there will be the addition of FES during treatment. For the Shoulder/elbow robotics + whole arm motor learning group there will be the addition of robotics training. Outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. Measures will include muscle strength (Manual Muscle Testing); coordination of joint movement (Fugl-Meyer Coordination Scale); motor control of target acquisition, pathway maintenance; and smoothness of movement (robotics measures); performance of 13 functional tasks (Arm Motor Ability Test); and quality of life (Stroke Impact Scale). Measures of brain function will be non-invasive and will include cognitive planning time, cognitive effort level, and location of brain activity during simple shoulder and arm movements. Changes in brain function measures will reflect plasticity or adaptability in response to treatment.
- Conditions
- Cerebral Stroke, Cerebrovascular Accident, Stroke
- Being tested
- Robotics training for shoulder elbow., Surface Functional Neuromuscular Stimulation, whole arm motor learning
- Keywords
- Motor Learning, Rehabilitation, Robotics, Therapeutic Electric Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotics training for shoulder elbow.Device
training utilizing a robot to assist with movement practice
Surface Functional Neuromuscular StimulationDevice
training utilizing FNS to assist with movement practice
whole arm motor learningOther
intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.
| Study group | Role | What they receive |
|---|---|---|
| Wrist/Hand FES + Whole Arm Motor Learning | Experimental | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning training and FES of the wrist/hand. Receives: Device: Surface Functional Neuromuscular Stimulation; Other: whole arm motor learning |
| Shoulder/Elbow Robotics + Whole Arm Motor Learning | Experimental | Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics. Receives: Device: Robotics training for shoulder elbow.; Other: whole arm motor learning |
| Whole Arm Motor Learning | Experimental | Subjects>6 months following first stroke with diminished upper limb strength, coordination and function who received whole arm motor learning training without addition of FES or Robotics Receives: Other: whole arm motor learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMAT
The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.
Measured: prior to treatment and following 3 months of treatment
M1 Activation Absolute Change Score
A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.
Measured: at baseline and following 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2011
- Study completionSep 2011
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 (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Janis Daly, PhD MS, Principal investigator, VA Medical Center-Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237744
- Sponsor's protocol ID
- B3709-I
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2005
- Last updated
- 13 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Fang Y, Yue GH, Hrovat K, Sahgal V, Daly JJ. Abnormal cognitive planning and movement smoothness control for a complex shoulder/elbow motor task in stroke survivors. J Neurol Sci. 2007 May 15;256(1-2):21-9. doi: 10.1016/j.jns.2007.01.078. Epub 2007 Mar 27.
PubMed 17391704Fang Y, Daly JJ, Sun J, Hvorat K, Fredrickson E, Pundik S, Sahgal V, Yue GH. Functional corticomuscular connection during reaching is weakened following stroke. Clin Neurophysiol. 2009 May;120(5):994-1002. doi: 10.1016/j.clinph.2009.02.173. Epub 2009 Apr 10.
PubMed 19362515Daly JJ, Hrovat K, Holcomb J, Pundik S. Brain control of functional reach in healthy adults and stroke survivors. Restor Neurol Neurosci. 2014;32(5):559-73. doi: 10.3233/RNN-130361.
PubMed 24613940Kisiel-Sajewicz K, Fang Y, Hrovat K, Yue GH, Siemionow V, Sun CK, Jaskolska A, Jaskolski A, Sahgal V, Daly JJ. Weakening of synergist muscle coupling during reaching movement in stroke patients. Neurorehabil Neural Repair. 2011 May;25(4):359-68. doi: 10.1177/1545968310388665. Epub 2011 Feb 22.
PubMed 21343527Wang XF, Jiang Z, Daly JJ, Yue GH. A generalized regression model for region of interest analysis of fMRI data. Neuroimage. 2012 Jan 2;59(1):502-10. doi: 10.1016/j.neuroimage.2011.07.079. Epub 2011 Jul 31.
PubMed 21839177Daly JJ, Hrovat K, Pundik S, Sunshine J, Yue G. fMRI methods for proximal upper limb joint motor testing and identification of undesired mirror movement after stroke. J Neurosci Methods. 2008 Oct 30;175(1):133-42. doi: 10.1016/j.jneumeth.2008.07.025. Epub 2008 Aug 22.
PubMed 18786565Philips GR, Daly JJ, Principe JC. Topographical measures of functional connectivity as biomarkers for post-stroke motor recovery. J Neuroeng Rehabil. 2017 Jul 6;14(1):67. doi: 10.1186/s12984-017-0277-3.
PubMed 28683745
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CNS Plasticity Induced By Motor Learning Technologies Following Stroke
- ClinicalTrials.gov ID
- NCT00237744
- Acronym / sponsor ID
- B3709-I
- Conditions
- Cerebral Stroke, Cerebrovascular Accident, Stroke
- Keywords
- Motor Learning, Rehabilitation, Robotics, Therapeutic Electric Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. This study will compare treatment response to robotics versus functional neuromuscular stimulation.
Detailed description
Methods. Up to ninety-six chronic stroke subjects (> 12 months post stroke) will be randomized to one of the treatment groups: Wrist/hand Functional Electrical Stimulation (FES)+whole arm motor learning group; shoulder/elbow robotics + whole arm motor learning group; and whole arm motor learning group. For all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. All three treatment groups will receive motor learning therapy. For the Wrist/hand FES+whole arm motor learning group, there will be the addition of FES during treatment. For the Shoulder/elbow robotics + whole arm motor learning group there will be the addition of robotics training. Outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. Measures will include muscle strength (Manual Muscle Testing); coordination of joint movement (Fugl-Meyer Coordination Scale); motor control of target acquisition, pathway maintenance; and smoothness of movement (robotics measures); performance of 13 functional tasks (Arm Motor Ability Test); and quality of life (Stroke Impact Scale). Measures of brain function will be non-invasive and will include cognitive planning time, cognitive effort level, and location of brain activity during simple shoulder and arm movements. Changes in brain function measures will reflect plasticity or adaptability in response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wrist/Hand FES + Whole Arm Motor Learning | Experimental | Device: Surface Functional Neuromuscular Stimulation, Other: whole arm motor learningSubjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning training and FES of the wrist/hand. |
| Shoulder/Elbow Robotics + Whole Arm Motor Learning | Experimental | Device: Robotics training for shoulder elbow., Other: whole arm motor learningSubjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics. |
| Whole Arm Motor Learning | Experimental | Other: whole arm motor learningSubjects>6 months following first stroke with diminished upper limb strength, coordination and function who received whole arm motor learning training without addition of FES or Robotics |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically stable and at least 12 months post stroke.
- Difficulty using upper limb for functional tasks.
- Age >21 years
Key exclusion criteria (1 listed)
- uncontrolled, chronic medical condition
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 |
|---|---|---|
| Robotics training for shoulder elbow.training utilizing a robot to assist with movement practice | Device | Shoulder/Elbow Robotics + Whole Arm Motor Learning |
| Surface Functional Neuromuscular Stimulationtraining utilizing FNS to assist with movement practice | Device | Wrist/Hand FES + Whole Arm Motor Learning |
| whole arm motor learningintervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks. | Other | Shoulder/Elbow Robotics + Whole Arm Motor Learning, Whole Arm Motor Learning, Wrist/Hand FES + Whole Arm Motor Learning |
Primary outcome
AMAT
Time frame: prior to treatment and following 3 months of treatment
The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.
M1 Activation Absolute Change Score
Time frame: at baseline and following 3 months of treatment
A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17391704Fang Y, Yue GH, Hrovat K, Sahgal V, Daly JJ. Abnormal cognitive planning and movement smoothness control for a complex shoulder/elbow motor task in stroke survivors. J Neurol Sci. 2007 May 15;256(1-2):21-9. doi: 10.1016/j.jns.2007.01.078. Epub 2007 Mar 27.
- Background: PubMed 19362515Fang Y, Daly JJ, Sun J, Hvorat K, Fredrickson E, Pundik S, Sahgal V, Yue GH. Functional corticomuscular connection during reaching is weakened following stroke. Clin Neurophysiol. 2009 May;120(5):994-1002. doi: 10.1016/j.clinph.2009.02.173. Epub 2009 Apr 10.
- Background: PubMed 24613940Daly JJ, Hrovat K, Holcomb J, Pundik S. Brain control of functional reach in healthy adults and stroke survivors. Restor Neurol Neurosci. 2014;32(5):559-73. doi: 10.3233/RNN-130361.
- Background: PubMed 21343527Kisiel-Sajewicz K, Fang Y, Hrovat K, Yue GH, Siemionow V, Sun CK, Jaskolska A, Jaskolski A, Sahgal V, Daly JJ. Weakening of synergist muscle coupling during reaching movement in stroke patients. Neurorehabil Neural Repair. 2011 May;25(4):359-68. doi: 10.1177/1545968310388665. Epub 2011 Feb 22.
- Background: PubMed 21839177Wang XF, Jiang Z, Daly JJ, Yue GH. A generalized regression model for region of interest analysis of fMRI data. Neuroimage. 2012 Jan 2;59(1):502-10. doi: 10.1016/j.neuroimage.2011.07.079. Epub 2011 Jul 31.
- Background: PubMed 18786565Daly JJ, Hrovat K, Pundik S, Sunshine J, Yue G. fMRI methods for proximal upper limb joint motor testing and identification of undesired mirror movement after stroke. J Neurosci Methods. 2008 Oct 30;175(1):133-42. doi: 10.1016/j.jneumeth.2008.07.025. Epub 2008 Aug 22.
- Derived from this study: PubMed 28683745Philips GR, Daly JJ, Principe JC. Topographical measures of functional connectivity as biomarkers for post-stroke motor recovery. J Neuroeng Rehabil. 2017 Jul 6;14(1):67. doi: 10.1186/s12984-017-0277-3.
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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.
Janis Daly, PhD MS principal investigator
VA Medical Center-Cleveland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotics training for shoulder elbow., Surface Functional Neuromuscular Stimulation and whole arm motor learning in people with Cerebral Stroke and Cerebrovascular Accident, 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 3 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: finished, as of the sponsor's last update on 13 Oct 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 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?
AMAT (time frame: prior to treatment and following 3 months of treatment). 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 NCT00237744, which also lists 7 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 13 Oct 2014.