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

NCT02032329 | Unknown Phase 1

• 2 other identifiers: S4UDR44HD065388
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Functional Electrical Stimulation (FES)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in "6-minute Walk Test (6MWT) for Distance" at 12 weeks

  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.

  weeks 0 and 12

Study Arms (1)

FastFES

EXPERIMENTAL

Single Group Study - see Intervention Description

Device: FastFES

Interventions

FastFES DEVICE

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.

FastFES

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• customKYnetics: lead
• University of Delaware: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Delaware - STAR Campus

Newark, Delaware, 19713, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stuart A Binder-Macleod, PT, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Wright, PT, DPT

CONTACT

302-831-7063; twright@udel.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 10, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

US (1)