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

NCT02389608.

Trial name or title The immediate effect of electrical stimulation transcranial direct current (tDCS) associated with the use of FES, in muscle activity of the tibialis anterior muscle, balance and plantar pressure distribution of individuals with hemiparesis due to stroke ‐ randomised, double blind
Methods Randomised cross‐over trial
Participants Estimated enrolment: 30
Inclusion criteria: age above 20 years; hemiparesis due to stroke; ability to maintain a standing position without an assistance device for at least 60 seconds; signed informed consent
Exclusion criteria: other health condition or use of medication affecting balance; positive cutoff point for cognitive deficit (MMSE); illiteracy; Wernicke's aphasia; reduced ankle mobility due to history of ankle fracture and use of pins in ankle; strength less than grade 1 in the tibialis anterior muscle; tDCS contraindication; skin infection at the tDCS/FES site; anaesthesia/hyperaesthesia at FES site
Interventions Each participant will undergo all of the following conditions
  1. A‐tDCS over M1 (2 mA for 20 minutes) + sham FES over the tibialis anterior muscle + active tibialis anterior muscle contraction

  2. Sham tDCS over M1 + active FES over the tibialis anterior muscle + active tibialis anterior muscle contraction

  3. A‐tDCS over M1 (2 mA for 20 minutes) + active FES over the tibialis anterior muscle + active tibialis anterior muscle contraction

  4. Sham tDCS over M1 + sham FES over the tibialis anterior muscle + active tibialis anterior muscle contraction

Outcomes Outcomes will be recorded at baseline and at 1 year after the end of intervention period
Primary outcome measure
  1. EMG activity of tibialis anterior muscle

Starting date January 2015
Contact information Aline M.A Fruhauf
University Nove de Julho
São Paulo, SP, Brazil
Notes