Enhanced Gait and Balance Training

Not Applicable

Completed

• Conditions: Accidental Falls; Aging
• Interventions: Device: Cranial Nerve Non-Invasive Neuromodulation; Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation

• Registration Number: NCT01896466
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-11
• Study Start: 2013-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Older Adults - Intervention	Cranial Nerve Non-Invasive Neuromodulation	Healthy subjects age 65+ will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training.
Older Fallers - Control	Sham Cranial Nerve Non-Invasive Neuromodulation	Subjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.
Young Adults - Intervention	Cranial Nerve Non-Invasive Neuromodulation	Healthy subjects between the ages of 18-39 will participate in Cranial Nerve Non-Invasive Neuromodulation gait and balance training.
Healthy Older Adults - Control	Sham Cranial Nerve Non-Invasive Neuromodulation	Healthy subjects between age 65+ will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.
Older Fallers - Intervention	Cranial Nerve Non-Invasive Neuromodulation	Subjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training.
Young Adult - Control	Sham Cranial Nerve Non-Invasive Neuromodulation	Healthy subjects between the ages of 18-39 will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.

Primary Outcome Measures

Name	Time	Method
Dynamic Gait Index	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.

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States