StrokePhase 1NCT01298583
Ankle Tracking Training in Stroke
A Phase 1 study testing ankle tracking training in people with Stroke, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to compare the improvement in ankle control and brain activation in subjects with stroke resulting from two different forms of telerehabilitation: tracking training, emphasizing accurate movements, versus movement training, involving simple movements. Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- ankle tracking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2010
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single stroke with an ischemic infarct.
- Between 18 and 85 years of age.
- Time since stroke onset must be >6 months.
- Cannot be receiving any rehabilitation therapy.
- Impaired ankle dorsiflexion/plantarflexion but at least 10 degrees of active motion.
- Cognition level must be at least 24 out of 30 on the Mini-Mental Examination 7. Able to ambulate at least 100 feet independently. training.
Who cannot join
- Cannot have any neuromuscular disorder other than stroke that impairs ankle motion.
- Cannot have an executive function score on Stroop Interference Test of <37.
- Cannot have a score on the Beck Depression Inventory of >10.
- Cannot have ataxia, apraxia, receptive aphasia, hemi-neglect, or severe visual field cut .
- Cannot be pregnant nor have indwelling metal or medical devices incompatible with fMRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The purpose of this study is to compare the improvement in ankle control and brain activation in subjects with stroke resulting from two different forms of telerehabilitation: tracking training, emphasizing accurate movements, versus movement training, involving simple movements.
Hypotheses:
- The Track group will show greater improvement in ankle range of motion compared to the Move group.
- The Track group will show greater improvement in ankle tracking accuracy and greater changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent (BOLD) signal intensity index) compared to Move group.
- The Track group will show greater improvement in tracking accuracy at an untrained joint (knee) compared to the Move group.
- The Track group will show greater improvement in standing balance.
- The Track group will show greater improvement in walking speed and ankle dorsiflexion during gait compared to the Move group.
- Conditions
- Stroke
- Being tested
- ankle tracking training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ankle tracking trainingBehavioural
one group will use the ankle for tracking, the other group will use the ankle for simple movement
| Study group | Role | What they receive |
|---|---|---|
| ankle tracking | Experimental | subjects track a target with ankle movement Receives: Behavioral: ankle tracking training |
| ankle movement | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ankle range of motion
Measured: Measurement at pretest, posttest and followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 MinnesotaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Carey, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298583
- Sponsor's protocol ID
- 0508M72871
- Status last verified
- Oct 2019
- First submitted
- 16 Feb 2011
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deng H, Durfee WK, Nuckley DJ, Rheude BS, Severson AE, Skluzacek KM, Spindler KK, Davey CS, Carey JR. Complex versus simple ankle movement training in stroke using telerehabilitation: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):197-209. doi: 10.2522/ptj.20110018. Epub 2011 Nov 17.
PubMed 22095209
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Tracking Training in Stroke
- ClinicalTrials.gov ID
- NCT01298583
- Acronym / sponsor ID
- 0508M72871
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Feb 2011 (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 compare the improvement in ankle control and brain activation in subjects with stroke resulting from two different forms of telerehabilitation: tracking training, emphasizing accurate movements, versus movement training, involving simple movements.
Hypotheses:
- The Track group will show greater improvement in ankle range of motion compared to the Move group.
- The Track group will show greater improvement in ankle tracking accuracy and greater changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent (BOLD) signal intensity index) compared to Move group.
- The Track group will show greater improvement in tracking accuracy at an untrained joint (knee) compared to the Move group.
- The Track group will show greater improvement in standing balance.
- The Track group will show greater improvement in walking speed and ankle dorsiflexion during gait compared to the Move group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ankle tracking | Experimental | Behavioral: ankle tracking trainingsubjects track a target with ankle movement |
| ankle movement | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Single stroke with an ischemic infarct.
- Between 18 and 85 years of age.
- Time since stroke onset must be >6 months.
- Cannot be receiving any rehabilitation therapy.
- Impaired ankle dorsiflexion/plantarflexion but at least 10 degrees of active motion.
Key exclusion criteria (5 listed)
- Cannot have any neuromuscular disorder other than stroke that impairs ankle motion.
- Cannot have an executive function score on Stroop Interference Test of <37.
- Cannot have a score on the Beck Depression Inventory of >10.
- Cannot have ataxia, apraxia, receptive aphasia, hemi-neglect, or severe visual field cut .
- Cannot be pregnant nor have indwelling metal or medical devices incompatible with fMRI.
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 |
|---|---|---|
| ankle tracking trainingone group will use the ankle for tracking, the other group will use the ankle for simple movement | Behavioural | ankle tracking |
Primary outcome
ankle range of motion
Time frame: Measurement at pretest, posttest and followup
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 1 Nov 2019.
- Derived from this study: PubMed 22095209Deng H, Durfee WK, Nuckley DJ, Rheude BS, Severson AE, Skluzacek KM, Spindler KK, Davey CS, Carey JR. Complex versus simple ankle movement training in stroke using telerehabilitation: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):197-209. doi: 10.2522/ptj.20110018. Epub 2011 Nov 17.
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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.
James Carey, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ankle tracking training in people with Stroke, run by University of Minnesota 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 6 inclusion and 5 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 1 Nov 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ankle range of motion (time frame: Measurement at pretest, posttest and followup). 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 NCT01298583, 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 1 Nov 2019.