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Enhanced Gait and Balance Training

NCT01896466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-07-31

No results posted yet for this study

Summary

The purpose of this study is twofold:

1. Establish baseline measures of gait performance in healthy young and older adults, and older adults with a history of falls.
2. Investigate the effects of gait and balance training with and without cranial nerve noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older adults.

For the second purpose, the study will incorporate a placebo-controlled design to evaluate the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups will perform gait and postural balance training (outlined in more detail below) but will differ in the stimulation level of the PoNS device. The investigators will use the results of this study as a first step toward evaluating the benefits of CN-NINM in a falls prevention program.

Conditions

  • Aging
  • Accidental Falls

Interventions

DEVICE

Cranial Nerve Non-Invasive Neuromodulation

Portable device delivers electrical stimulation to cranial nerves V and VII via an electrode array placed on the anterior surface of the tongue. Stimulation is combined with rehabilitation exercises targeting walking and balance.

BEHAVIORAL

Sham Cranial Nerve Non-Invasive Neuromodulation

Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Darryl G Thelen, PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01896466 on ClinicalTrials.gov