StrokeNCT01160653
Cognitive & Motor Training After Stroke For Everyday Walking Restoration
A study testing FES-IM and Cognitive training in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to test a unique, combined cognitive and motor intervention designed to restore safe, more normal coordinated gait components into the real world environment for individuals with stroke. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- FES-IM and Cognitive training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- greater than or equal to 6 months post stroke
- ability to give informed consent
- impaired gait
- medically stable
Who cannot join
- pacemaker
- unstable/uncontrolled medical condition(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive and Motor Training After Stroke for Everyday Walking Restoration
The purpose of this study is to test a unique, combined cognitive and motor intervention designed to restore safe, more normal coordinated gait components into the real world environment for individuals with stroke.
- Conditions
- Stroke
- Being tested
- FES-IM, Cognitive training
- Keywords
- stroke, Gait training, Cognitive Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES-IMDevice
implantable Functional Electrical Stimulation
Cognitive trainingOther
training of impaired cognitive processes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gait training and Cognitive Training Receives: Device: FES-IM; Other: Cognitive training |
| 2 | No intervention | Able Bodied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.)
Measured: post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Never funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT01160653
- Sponsor's protocol ID
- UNF1
- Status last verified
- Feb 2014
- First submitted
- 26 Apr 2010
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Motor Training After Stroke for Everyday Walking Restoration
- ClinicalTrials.gov ID
- NCT01160653
- Acronym / sponsor ID
- UNF1
- Conditions
- Stroke
- Keywords
- stroke, Gait training, Cognitive Training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Jul 2010 (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.
The purpose of this study is to test a unique, combined cognitive and motor intervention designed to restore safe, more normal coordinated gait components into the real world environment for individuals with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: FES-IM, Other: Cognitive trainingGait training and Cognitive Training |
| 2 | No intervention | –Able Bodied |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- greater than or equal to 6 months post stroke
- ability to give informed consent
- impaired gait
- medically stable
Key exclusion criteria (2 listed)
- pacemaker
- unstable/uncontrolled medical condition(s)
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 |
|---|---|---|
| FES-IMimplantable Functional Electrical Stimulation | Device | 1 |
| Cognitive trainingtraining of impaired cognitive processes | Other | 1 |
Primary outcome
Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.)
Time frame: post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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 FES-IM and Cognitive training in people with Stroke, 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 2 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: withdrawn, as of the sponsor's last update on 25 Feb 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.) (time frame: post treatment). 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 25 Feb 2014.