Enhanced Gait and Balance Training

Influence of Neuromodulation on Gait and Balance

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 Overview

• Status: Completed
• Conditions: Aging; Accidental Falls
• Intervention / Treatment: Device: Cranial Nerve Non-Invasive Neuromodulation; Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Young Adults - Intervention; Healthy subjects between the ages of 18-39 will participate in Cranial Nerve Non-Invasive Neuromodulation gait and balance training.	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.; Other Names: PoNS (Portable Neuromodulation Stimulator)
Active Comparator: Healthy Older Adults - Control; Healthy subjects between age 65+ will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.	Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation; Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels.
Active Comparator: Healthy Older Adults - Intervention; Healthy subjects age 65+ will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training.	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.; Other Names: PoNS (Portable Neuromodulation Stimulator)
Sham Comparator: Older Fallers - Control; 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.	Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation; Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels.
Experimental: Older Fallers - Intervention; 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.	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.; Other Names: PoNS (Portable Neuromodulation Stimulator)
Active Comparator: Young Adult - Control; Healthy subjects between the ages of 18-39 will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.	Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation; Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 and approximately Day 12

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Darryl G Thelen, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Neuromodulation; Gait; Fall Risk; Dynamic Balance; Static Balance
• Other Study ID Numbers: 2013-0394

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No