NCT01896466

Enhanced Gait and Balance Training

Influence of Neuromodulation on Gait and Balance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-07-11
• Last updated: 2019-07-31

Locations

1 site across 1 country: United States