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. 2017 May 10;2017(5):CD006185. doi: 10.1002/14651858.CD006185.pub4

NCT02471248.

Trial name or title Interactive exoskeleton robot for walking ‐ ankle joint
Methods Randomised
2 arms
Participants Inclusion criteria
  • Ischaemic or haemorrhagic stroke with drop‐foot problem

  • Sufficient cognition to follow simple instructions and to understand the content and purpose of the study (Mini Mental State Examination > 21)

  • Capable of standing and walking independently for an extended period of time (FAC > 3, Berg Balance Scale > 40)


Exclusion criteria
  • Any medical or psychological dysfunctions that would affect ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, musculoskeletal disorders, injuries, and pregnancy

  • Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity

  • Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the follow‐up

Interventions
  • Experimental: ankle robot with power assistance. The ankle robot assists the ankle dorsiflexion when the stroke patient voluntarily performs the swing phase gait movement.

  • Placebo comparator: sham group. The ankle robot provides very low assistance to generate tactile feedback to the stroke patient indicating the patient is performing the swing phase gait movement, but no assistance will be given to support ankle dorsiflexion.

Outcomes
  • Fugl‐Meyer Assessment Lower Extremity

  • Timed 10‐metre walk test

  • 6‐minute walk test

  • Berg Balance Scale

  • Modified Ashworth Scale

  • Kinematic and Kinetic Gait Motion Capture

  • Subjective feedback questionnaire

Starting date June 2015
Contact information Raymond KY Tong, Professor, Chinese University of Hong Kong
Notes