Stroke Gait Rehabilitation Using Functional Electrical Stimulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Trisha Kesar, PT, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT01668602
First received: August 15, 2012
Last updated: April 27, 2014
Last verified: April 2014
  Purpose

Stroke is the number one cause of disability. Difficulty with walking affects most stroke survivors. The focus of this project is to understand the effects of different methods (such as treadmill walking and electrical stimulation) that can be used to improve walking in people with stroke. In this study, patients with stroke and healthy people who have not had a stroke will be tested. Study participants will take part in 12 sessions of walking training. Walking patterns will be measured using automatic cameras and standard clinical tests. Also, magnetic brain stimulation maybe used to measure brain-muscle connections during the training. This research will provide information on how different factors that affect walking in stroke change with walking training. The investigators hypothesize that improvements in brain excitability of the muscles targeted by walking training will occur after training, and these changes in brain excitability will be related to improvements in walking patterns. By improving our understanding of walking rehabilitation, this study can help improve walking function and disability in people with stroke.


Condition Intervention
Cerebrovascular Accident
Other: Walking with ankle electrical stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Cortical and Spinal Correlates of Post-stroke Gait Rehabilitation

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • walking performance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    forward propulsion forces during gait, knee flexion during gait, over ground walking speed


Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fast treadmill walking with ankle electrical stimulation
Fast treadmill walking with ankle electrical stimulation
Other: Walking with ankle electrical stimulation
Fast treadmill walking with electrical stimulation delivered to the ankle dorsi- and plantar-flexor muscles

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic stroke (>6 months post stroke)
  • First (single) lesion
  • Able to walk with or without the use of a cane or walker
  • Sufficient cardiovascular health and ankle stability to walk for 6 minutes at a self-selected speed without an orthoses
  • Resting heart rate 40-100 beats per minute

Exclusion Criteria:

  • Evidence of moderate/ severe chronic white matter disease or cerebellar stroke on MRI
  • Cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
  • Insulin dependent diabetes
  • History of lower extremity joint replacement
  • Score of >1 on question 1b and >0 on question 1c on NIH Stroke Scale
  • Inability to communicate with investigators
  • Neglect/hemianopia, or unexplained dizziness in last 6 months
  • Neurologic conditions other than stroke
  • Orthopedic problems in the lower limbs/spine or other problems that limit walking
  • Contra-indications to Transcranial magnetic stimulation (history of seizures, metal implants in the head, presence of skull fractures, etc).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668602

Contacts
Contact: Trisha Kesar, PT, PhD 404-712-5803 trisha.m.kesar@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Trisha Kesar, PhD    404-712-5803    trisha.m.kesar@emory.edu   
Principal Investigator: Trisha Kesar, PhD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Trisha Kesar, PT, PhD Emory University
  More Information

No publications provided

Responsible Party: Trisha Kesar, PT, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01668602     History of Changes
Other Study ID Numbers: IRB00058363
Study First Received: August 15, 2012
Last Updated: April 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014