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

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ClinicalTrials.gov Identifier: NCT02032329
Recruitment Status : Unknown
Verified January 2014 by customKYnetics.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Collaborators:
University of Delaware
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
customKYnetics

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.

Condition or disease Intervention/treatment Phase
Stroke Gait Device: FastFES Phase 1 Phase 2

Detailed Description:

Difficulty with walking is one of the most common effects of stroke. Even after rehabilitation, a majority of stroke survivors have decreased speed, endurance, confidence, and quality of walking. Walking deficits can cause risks of falls, slow walking speed, increased effort of walking, and difficulties with activities of daily living. Restoration of walking ability can improve quality of life, and is perceived as a major goal of rehabilitation by stroke survivors. There has therefore been renewed interest in research toward developing novel gait rehabilitation treatments and improving existing treatments. FastFES is one such intervention, which improves walking post-stroke using a combination of fast treadmill training and functional electrical stimulation (FES).

Ongoing research at the University of Delaware (R01NR010786) shows that a 12-week FastFES gait rehabilitation program improves walking function, activity, and community participation in stroke survivors.

In order to facilitate implementation of the FastFES gait rehabilitation program in the clinical setting, there is a need to transition from the currently used stimulation system to a more portable stimulation system. The Study Device under evaluation is a pre-commercial prototype (developed by customKYnetics, Inc.) of a clinically viable portable electrical stimulation system that can deliver FES during gait using similar timing and parameters as are being used during FastFES gait rehabilitation training in the ongoing research.

The main goal of the efficacy study is to demonstrate clinical efficacy of the customKYnetics FastFES prototype system for improving the gait of individuals with paresis secondary to stroke. Fifteen (15) post-stroke subjects who meet the inclusion/exclusion criteria will be recruited for participation in this prospective, non-randomized, non-blinded cohort interventional study.

Training (intervention sessions) will be conducted 2-3 times per week for approximately 12 weeks for a total of 36 total sessions. Functional Electrical Stimulation (FES) to the ankle plantarflexor and dorsiflexor muscle groups will be delivered during the gait cycle using a variable frequency train (VFT) stimulation pattern. Stimulation will be coordinated to the gait cycle using data from a shoe-worn inertial sensor and proprietary real-time signal processing algorithm. Stimulation will be turned on and off in 1-minute increments during the training bouts to promote motor learning. The treadmill will be set to the patient's fastest comfortable walking speed. Each intervention session will conclude with a single overground walking session without FES.

Outcome measures assessments will be performed at the following milestones: pre-intervention, after 18 training sessions, post-intervention, and at a 12-week follow-up. This Small Business Innovation Research (SBIR) funded efficacy study will mimic the study protocol used in the R01-funded randomized controlled trial (RCT). Outcomes from the SBIR cohort will be compared to non-concurrent (e.g., historical) control groups drawn from the R01-funded RCT. The main outcomes of this study will be: 1) validation of customKYnetics' prototype system for improving gait deficits; and 2) comparison of the outcome measures of patients who trained with the customKYnetics system with those from the 'fast treadmill walking with FES' arm intervention cohort in the RCT.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FastFES Gait Training for Stroke Patients: Efficacy of Pre-Commercial Device
Study Start Date : January 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: FastFES
Single Group Study - see Intervention Description
Device: 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 Measures :
  1. Change from baseline in "6-minute Walk Test (6MWT) for Distance" at 12 weeks [ Time Frame: weeks 0 and 12 ]
    Distance (meters) walked during the 6-minute Walk Test, a standard clinical assessment of gait will be assessed at 0 and 12 weeks. Test will be performed overground without FES. Change from baseline at 12 weeks will be computed.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032329


Contacts
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Contact: Tamara Wright, PT, DPT 302-831-7063 twright@udel.edu

Locations
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United States, Delaware
University of Delaware - STAR Campus Recruiting
Newark, Delaware, United States, 19713
Principal Investigator: Stuart A Binder-Macleod, PT, PhD         
Sponsors and Collaborators
customKYnetics
University of Delaware
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Stuart A Binder-Macleod, PT, PhD University of Delaware

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Responsible Party: customKYnetics
ClinicalTrials.gov Identifier: NCT02032329     History of Changes
Other Study ID Numbers: S4UD
R44HD065388 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by customKYnetics:
Functional Electrical Stimulation (FES)
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases