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Ankle Tracking Training in Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01298583
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE February 16, 2011
First Posted Date  ICMJE February 17, 2011
Last Update Posted Date November 1, 2019
Study Start Date  ICMJE January 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
ankle range of motion [ Time Frame: Measurement at pretest, posttest and followup ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ankle Tracking Training in Stroke
Official Title  ICMJE Ankle Tracking Training in Stroke
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Behavioral: ankle tracking training
one group will use the ankle for tracking, the other group will use the ankle for simple movement
Study Arms  ICMJE
  • Experimental: ankle tracking
    subjects track a target with ankle movement
    Intervention: Behavioral: ankle tracking training
  • No Intervention: ankle movement
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2012)
16
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01298583
Other Study ID Numbers  ICMJE 0508M72871
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Carey, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP