Stroke Gait Rehabilitation Using Functional Electrical Stimulation

This study is currently recruiting participants.
Verified July 2013 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: July 24, 2013
Last verified: July 2013

August 15, 2012
July 24, 2013
August 2012
December 2016   (final data collection date for primary outcome measure)
walking performance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
forward propulsion forces during gait, knee flexion during gait, over ground walking speed
Same as current
Complete list of historical versions of study NCT01668602 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Stroke Gait Rehabilitation Using Functional Electrical Stimulation
Bio-mechanical and Neural Mechanisms Underlying Post-stroke Gait Rehabilitation

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 will be used to measure brain-muscle connections at every session. 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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Cerebrovascular Accident
  • Healthy
Other: Walking with ankle electrical stimulation
Fast treadmill walking with electrical stimulation delivered to the ankle dorsi- and plantar-flexor muscles
Experimental: Walking with ankle electrical stimulation
Fast treadmill walking with ankle electrical stimulation
Intervention: Other: Walking with ankle electrical stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic stroke (>6 months post stroke) involving cerebral cortical regions
  • 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 or spine that limit walking
  • Contra-indications to Transcranial magnetic stimulation (history of seizures, metal implants in the head, presence of skull fractures, etc).
Both
30 Years to 80 Years
Yes
Contact: Trisha Kesar, PT, PhD 404-712-5803 trisha.m.kesar@emory.edu
United States
 
NCT01668602
IRB00058363
No
Trisha Kesar, PT, PhD, Emory University
Emory University
Not Provided
Principal Investigator: Trisha Kesar, PT, PhD Emory University
Emory University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP