Enhanced Gait and Balance Training

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.

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Key information

Conditions

Aging Accidental Falls

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53706, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Community-dwelling
Able to understand and give informed consent
Able to stand and walk independently without an assistive device
No contraindication to exercise

Healthy young adults
Between ages of 18 and 39
Scores above 19 on Dynamic Gait Index 2. Healthy older adults without a history of falls
Age 65+
Scores above 19 on Dynamic Gait Index 3. Older adults with a history of falls
Age 65+
Self-reported history of 1-3 falls in previous year
Scores of 19 and below on the Dynamic Gait Index

Exclusion criteria

History of musculoskeletal disorders (lower-limb joint replacement, radiographic evidence of severe osteoarthritis, broken leg bone or ligament/tendon injury in prior 6 months)
Use of tobacco products
Any oral abrasions, cuts, cold sores, piercings, tissue inflammation, or have had oral surgery within the previous 3 months
Have a pacemaker or are identified as at-risk for cardiovascular events
Have a biomechanical prosthetic
If female, self-report of being pregnant
Neurological condition
Prisoners
Individuals clearly lacking the capacity to provide informed consent

Treatment and study plan

Cranial Nerve Non-Invasive Neuromodulation

Device

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.

Other names: PoNS (Portable Neuromodulation Stimulator)

Sham Cranial Nerve Non-Invasive Neuromodulation

Behavioral

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

Primary outcomes

Dynamic Gait Index

Time frame: Day 1 and approximately Day 12

An 8-item inventory of functional gait tasks each scored on a 0-3 point scale. Maximum score is 24 and any score of 19 or lower indicates an increased risk of falling.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Influence of Neuromodulation on Gait and Balance

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 11, 2013
Registry last updated: Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed