Recruiting
Phase 1
Phase 2

FastFES

Sponsor:

customKYnetics

Code:

NCT02032329

Conditions

Stroke

Gait

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

FastFES

Study Details

Brief summary:

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.

Conditions

Stroke

Gait

Study ID

NCT02032329

Start date

Jan, 2014

Status verified date

Jan, 2014

Completion date

Mar, 2015

Anticipated

Primary completion date

Mar, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FastFES

Single Group Study - see Intervention Description

Interventions

FastFES

Fast treadmill walking supplemented with FES to ankle plantarflexor and dorsiflexor muscles, using a VFT stimulation pattern. 12 weeks of 2-3x/week. Stimulation delivered using the customKYnetics study device.

Primary outcome measure

  • Change from baseline in "6-minute Walk Test (6MWT) for Distance" at 12 weeks [ Time Frame: weeks 0 and 12 ]

Central Contacts and Locations

Central contacts

Tamara Wright, PT, DPT

302-831-7063twright@udel.edu

Locations

University of Delaware - STAR Campus

Recruiting

Newark, Delaware, United States, 19713

Principal Investigator:

Stuart A Binder-Macleod, PT, PhD

More Information

Sponsor

customKYnetics

Last update posted

Jan 10, 2014

Last verified

Jan, 2014

Keywords

  • Functional Electrical Stimulation (FES)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by customKYnetics on 2014-01-10.