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. 2016 Mar 21;2016(3):CD009645. doi: 10.1002/14651858.CD009645.pub3

NCT01807637.

Trial name or title Using transcranial direct current stimulation to jump start gait training in chronic stroke patients
Methods RCT with parallel‐group design
Participants Estimated enrolment: 88
Inclusion criteria: stroke > 3 months prior to enrolment; unilateral stroke; MRI‐confirmed; age > 30 years; complete NIHSS; sufficient endurance motor ability and balance to ambulate at least 10 meters; ankle dorsiflexion passive ROM > 0°; demonstrating foot‐drop during ambulation such that gait instability or inefficient gait patterns are exhibited; pass the TMS Adult Safety Screen (TASS)
Exclusion criteria: oedema; skin breakdown; absent sensation of the affected lower limb, which interferes with the peroneal nerve stimulator; serious cardiac arrhythmia; pacemakers or any other implanted electronic systems; pregnancy; uncontrolled seizures; Parkinson's Disease; spinal cord injury, traumatic brain injury; multiple sclerosis; fixed ankle plantar flexor contracture; history of dementia, severely impaired cognition, communication or comprehension; severe or frequent headaches; history of BOTOX injection within 3 months prior to enrolment; receiving other forms of electrical stimulation; other medical conditions or medications that compromise ambulation or balance; PI's or Medical Monitor's discretion not to include a participant
Interventions 2 arms
  1. A‐tDCS over the low extremity representation of M1 of the affected hemisphere (dosage not stated)

  2. Sham tDCS over the low extremity representation of M1 of the affected hemisphere (30 seconds)

Outcomes Outcomes will be recorded at baseline, at 1 week, 1 month and at 6 months postintervention
Primary outcome measures
  1. Change from baseline in ankle dorsiflexion during the swing phase of gait


Secondary outcome measures
  1. Change from baseline in slope of cortical recruitment curve

  2. Change from baseline in SIS scores

Starting date March 2013
Contact information Chad I Lairamore, PhD; chadl@uca.edu
University of Central Arkansas
Conway, Arkansas, United States, 72035
Notes