We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stroke Gait Rehabilitation Using Functional Electrical Stimulation

This study is currently recruiting participants.
Verified July 2017 by Trisha Kesar, PT, PhD, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668602
First Posted: August 20, 2012
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Trisha Kesar, PT, PhD, Emory University
  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 walking evaluation and training sessions. Walking patterns will be measured using automatic cameras and standard clinical tests. Also, magnetic brain stimulation maybe used to measure brain-muscle connections, and muscle stimulation may be used to measure spinal-cord circuits 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: Fast walking and FES Other: Fast treadmill walking

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cortical and Spinal Correlates of Post-stroke Gait Rehabilitation

Resource links provided by NLM:


Further study details as provided by Trisha Kesar, PT, PhD, Emory University:

Primary Outcome Measures:
  • walking performance [ Time Frame: 6-10 weeks ]
    forward propulsion forces during gait, over ground walking speed


Estimated Enrollment: 80
Study Start Date: August 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fast walking and FES
Fast treadmill walking with ankle electrical stimulation
Other: Fast walking and FES
Fast treadmill walking with electrical stimulation delivered to the ankle dorsi- and plantar-flexor muscles
Active Comparator: Fast treadmill walking
Fast treadmill walking without electrical stimulation
Other: Fast treadmill walking
Fast treadmill walking without electrical stimulation

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Trisha Kesar, PT, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01668602     History of Changes
Other Study ID Numbers: IRB00058363
First Submitted: August 15, 2012
First Posted: August 20, 2012
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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