Ankle Tracking Training in Stroke

Stroke Clinical Trial

Official title:

Ankle Tracking Training in Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298583
• Other study ID #: 0508M72871
• Status: Completed
• Phase: Phase 1
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2010
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• ankle tracking training
one group will use the ankle for tracking, the other group will use the ankle for simple movement

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ankle range of motion		Measurement at pretest, posttest and followup