Enhanced Gait and Balance Training

University of Wisconsin, Madison39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Aging Accidental Falls

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 1\. 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

Outcomes

Primary Outcomes

Dynamic Gait Index

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.

Time frame: Day 1 and approximately Day 12