Ankle Tracking Training in Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01298583
First received: February 16, 2011
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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.

Condition Intervention Phase
Stroke
Behavioral: ankle tracking training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ankle Tracking Training in Stroke

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • ankle range of motion [ Time Frame: Measurement at pretest, posttest and followup ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ankle tracking
subjects track a target with ankle movement
Behavioral: ankle tracking training
one group will use the ankle for tracking, the other group will use the ankle for simple movement
No Intervention: ankle movement

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298583

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: James Carey, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01298583     History of Changes
Other Study ID Numbers: Ankle tracking training
Study First Received: February 16, 2011
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 15, 2014