Ankle Tracking Training in Stroke

NCT01298583 | Completed Phase 1 DMC

• 1 other identifier: 0508M72871
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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:

1. 1.The Track group will show greater improvement in ankle range of motion compared to the Move group.
2. 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. 3.The Track group will show greater improvement in tracking accuracy at an untrained joint (knee) compared to the Move group.
4. 4.The Track group will show greater improvement in standing balance.
5. 5.The Track group will show greater improvement in walking speed and ankle dorsiflexion during gait compared to the Move group.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• ankle range of motion

  Measurement at pretest, posttest and followup

Study Arms (2)

ankle tracking

EXPERIMENTAL

subjects track a target with ankle movement

Behavioral: ankle tracking training

ankle movement

NO INTERVENTION

Interventions

ankle tracking training BEHAVIORAL

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

ankle tracking

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 22095209 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• James Carey, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 17, 2011
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: December 1, 2010
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)