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Ankle Tracking Training in Stroke

Primary Purpose

Stroke

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ankle tracking training

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ankle tracking

ankle movement

Arm Description

subjects track a target with ankle movement

Outcomes

Primary Outcome Measures

ankle range of motion

Secondary Outcome Measures

Full Information

NCT ID

NCT01298583

First Posted

February 16, 2011

Last Updated

October 30, 2019

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT01298583

Brief Title

Ankle Tracking Training in Stroke

Official Title

Ankle Tracking Training in Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ankle tracking

Arm Type

Experimental

Arm Description

subjects track a target with ankle movement

Arm Title

ankle movement

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

ankle tracking training

Intervention Description

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

Primary Outcome Measure Information:

Title

ankle range of motion

Time Frame

Measurement at pretest, posttest and followup

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Carey, PhD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22095209

Citation

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.

Results Reference

derived

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Ankle Tracking Training in Stroke

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