Enhanced Gait and Balance Training

NCT01896466 | Completed DMC

• 1 other identifier: 2013-0394
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is twofold:

1. 1.Establish baseline measures of gait performance in healthy young and older adults, and older adults with a history of falls.
2. 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.

Conditions

Aging; Accidental Falls

Keywords

Fall Risk; Gait; Dynamic Balance; Static Balance; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Young Adults - Intervention

ACTIVE COMPARATOR

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

Healthy Older Adults - Control

ACTIVE COMPARATOR

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

Healthy Older Adults - Intervention

ACTIVE COMPARATOR

Healthy subjects age 65+ will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training.

Device: Cranial Nerve Non-Invasive Neuromodulation

Older Fallers - Control

SHAM COMPARATOR

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

Older Fallers - Intervention

EXPERIMENTAL

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

Young Adult - Control

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: PoNS (Portable Neuromodulation Stimulator)

Healthy Older Adults - Intervention; Older Fallers - Intervention; Young Adults - Intervention

Sham Cranial Nerve Non-Invasive Neuromodulation BEHAVIORAL

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

Healthy Older Adults - Control; Older Fallers - Control; Young Adult - Control

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53706, United States

Location

Study Officials

• Darryl G Thelen, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: July 11, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

US (1)