Ankle Tracking Training in Stroke

October 30, 2019 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ankle range of motion
Time Frame: Measurement at pretest, posttest and followup
Measurement at pretest, posttest and followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: James Carey, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0508M72871

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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