FastFES Gait Training for Stroke Patients: Efficacy of Pre-Commercial Device

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Stroke, Gait

In brief

The purpose of this study is to assess efficacy of a pre-commercial device capable of activating both the ankle plantarflexor and dorsiflexor muscles using electrical stimulating during treadmill-based gait training for stroke patients.

Key facts

Study ID

NCT02032329

Run by

customKYnetics

People needed

15

Starts

2014-01-01

Expected to finish

2015-03-01

Last updated by the study team

2014-01-10

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21-80
• Chronic stroke involving cerebral cortical regions (>6 months post stroke).
• First (single) lesion
• Ambulatory but with residual gait deficit, including those who use a cane or walker and/or demonstrate asymmetry during gait
• Able to walk for 6 minutes at their self-selected speed with no orthotic support.
• Passive ankle dorsiflexion range of motion to neutral degrees with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
• Passive hip extension of >10 degrees
• Resting heart rate between 40-100 beats per minute
• Resting blood pressure between the range of 90/60 to 170/90

You may not qualify if…

• Evidence of moderate to severe chronic white matter disease on MRI
• Evidence of cerebellar stroke on MRI
• History of lower extremity joint replacement due to arthritis •Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
• Inability to communicate with investigators
• Neglect and hemianopia
• Unexplained dizziness in the last 6 months

Where it is running

• University of Delaware - STAR Campus — Newark, Delaware, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.