Ankle Tracking Training in Stroke

NCT ID: NCT01298583

Last Updated: 2019-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ankle tracking

subjects track a target with ankle movement

Group Type EXPERIMENTAL

ankle tracking training

Intervention Type BEHAVIORAL

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

ankle movement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ankle tracking training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Carey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22095209 (View on PubMed)

Other Identifiers

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0508M72871

Identifier Type: -

Identifier Source: org_study_id

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