Cerebrovascular AccidentNCT01725659
Innovative Modalities for Restoring Upper Limb Function Post Stroke
A study testing Motor Learning, Robotics and surface FES in people with Cerebrovascular Accident, run by Malcom Randall VA Medical Center at 1 site in United States.
Trial summary
PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Motor Learning, Robotics and surface FES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >1 year post stroke no acute, uncontrolled medical condition single stroke
Who cannot join
- pacemaker other neurological condition more than one stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes Cleveland Department of Veterans Affairs Medical Center
Cleveland, Ohio, 44118
About this study
PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).
- Conditions
- Cerebrovascular Accident
- Being tested
- Motor Learning, Robotics, surface FES
- Keywords
- Stroke, electric stimulation, robotics, motor learning
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor LearningOther
training of the hemiplegic upper limb with motor learning
RoboticsOther
subjects perform training of hemiplegic arm using an upper extremity robot
surface FESOther
subjects are provided with surface FES to the hemiplegic upper limb
| Study group | Role | What they receive |
|---|---|---|
| Motor Learning | Experimental | subjects are provided with intensive motor learning training of the upper limb Receives: Other: Motor Learning |
| Robotics and Motor Learning | Experimental | subject are provided with intensive motor learning and robotics training of the upper limb Receives: Other: Motor Learning; Other: Robotics |
| Motor learning and FES | Experimental | subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb Receives: Other: Motor Learning; Other: surface FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer
impairment measure of coordination of the upper limb
Measured: after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startSep 2001
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malcom Randall VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Janis Daly, Malcom Randall VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725659
- Sponsor's protocol ID
- B2801R
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Modalities for Restoring Upper Limb Function Post Stroke
- ClinicalTrials.gov ID
- NCT01725659
- Acronym / sponsor ID
- B2801R
- Conditions
- Cerebrovascular Accident
- Keywords
- Stroke, electric stimulation, robotics, motor learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Malcom Randall VA Medical CenterUS federal agency
- Study start
- Sep 2001
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Nov 2012 (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.
PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor Learning | Experimental | Other: Motor Learningsubjects are provided with intensive motor learning training of the upper limb |
| Robotics and Motor Learning | Experimental | Other: Motor Learning, Other: Roboticssubject are provided with intensive motor learning and robotics training of the upper limb |
| Motor learning and FES | Experimental | Other: Motor Learning, Other: surface FESsubjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >1 year post stroke no acute, uncontrolled medical condition single stroke
Key exclusion criteria (1 listed)
- pacemaker other neurological condition more than one stroke
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 |
|---|---|---|
| Motor Learningtraining of the hemiplegic upper limb with motor learning | Other | Motor Learning, Motor learning and FES, Robotics and Motor Learning |
| Roboticssubjects perform training of hemiplegic arm using an upper extremity robot | Other | Robotics and Motor Learning |
| surface FESsubjects are provided with surface FES to the hemiplegic upper limb | Other | Motor learning and FES |
Primary outcome
Fugl Meyer
Time frame: after 12 weeks of intervention
impairment measure of coordination of the upper limb
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 14 Nov 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Learning, Robotics and surface FES in people with Cerebrovascular Accident, run by Malcom Randall VA Medical Center 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 1 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 14 Nov 2012. 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?
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 (time frame: after 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2012.