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CompletedNCT01298583Updated Nov 1, 2019

Ankle Tracking Training in Stroke

A Phase 1 interventional study of ankle tracking training in Stroke, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-11-01.

Sponsored by University of Minnesota · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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. The Track group will show greater improvement in ankle range of motion compared to the Move group.
  2. 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.
  3. The Track group will show greater improvement in tracking accuracy at an untrained joint (knee) compared to the Move group.
  4. The Track group will show greater improvement in standing balance.
  5. The Track group will show greater improvement in walking speed and ankle dorsiflexion during gait compared to the Move group.
02

Conditions studied

  • Stroke

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03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 16 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

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Lead sponsor

University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.

Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Single stroke with an ischemic infarct.
  2. Between 18 and 85 years of age.
  3. Time since stroke onset must be >6 months.
  4. Cannot be receiving any rehabilitation therapy.
  5. Impaired ankle dorsiflexion/plantarflexion but at least 10 degrees of active motion.
  6. 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.

Exclusion criteria

Exclusion Criteria:

  1. Cannot have any neuromuscular disorder other than stroke that impairs ankle motion.
  2. Cannot have an executive function score on Stroop Interference Test of \<37.
  3. Cannot have a score on the Beck Depression Inventory of >10.
  4. Cannot have ataxia, apraxia, receptive aphasia, hemi-neglect, or severe visual field cut .
  5. Cannot be pregnant nor have indwelling metal or medical devices incompatible with fMRI.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    ankle tracking

    subjects track a target with ankle movement

    Behavioral: ankle tracking training

  • No intervention
    ankle movement

Interventions

  • Behavioralankle tracking training

    one group will use the ankle for tracking, the other group will use the ankle for simple movement

06

What researchers measure

Primary outcomes

  1. ankle range of motion

    Time frame: Measurement at pretest, posttest and followup

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2007, a primary completion of Jan 2008 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2011
First posted
Feb 17, 2011
Start
Jan 2007
Primary completionActual
Jan 2008
CompletionActual
Dec 2010
Last update
Nov 1, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01298583
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Feb 17, 2011
Start date
Jan 2007
Primary completion
Jan 2008
Completion
Dec 2010
Last update
Nov 1, 2019

Study contacts

James Carey, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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