Enhanced Gait and Balance Training

Completed · Not applicable · Has a placebo group

Conditions studied: Aging, Accidental Falls

In brief

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.

Key facts

Study ID

NCT01896466

Run by

University of Wisconsin, Madison

People needed

39

Starts

2013-09-01

Expected to finish

2015-12-01

Last updated by the study team

2019-07-31

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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