Stroke Gait Rehabilitation Using Functional Electrical Stimulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 8, 2014
Last verified: December 2014

August 15, 2012
December 8, 2014
August 2012
December 2018   (final data collection date for primary outcome measure)
walking performance [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]
forward propulsion forces during gait, knee flexion during gait, over ground walking speed
walking performance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
forward propulsion forces during gait, knee flexion during gait, over ground walking speed
Complete list of historical versions of study NCT01668602 on ClinicalTrials.gov Archive Site
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Stroke Gait Rehabilitation Using Functional Electrical Stimulation
Cortical and Spinal Correlates of 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 18 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, 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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Cerebrovascular Accident
  • Other: Fast walking and FES
    Fast treadmill walking with electrical stimulation delivered to the ankle dorsi- and plantar-flexor muscles
  • Other: Fast treadmill walking
    Fast treadmill walking without electrical stimulation
  • Experimental: Fast walking and FES
    Fast treadmill walking with ankle electrical stimulation
    Intervention: Other: Fast walking and FES
  • Active Comparator: Fast treadmill walking
    Fast treadmill walking without electrical stimulation
    Intervention: Other: Fast treadmill walking
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2019
December 2018   (final data collection date for primary outcome measure)

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).
Both
30 Years to 80 Years
No
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
December 2014

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