Enhanced Gait and Balance Training

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01896466
First received: June 10, 2013
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Aging
Accidental Falls
Device: Cranial Nerve Non-Invasive Neuromodulation
Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Influence of Neuromodulation on Gait and Balance

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Dynamic Gait Index [ Time Frame: Day 1 and approximately Day 12 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 six months
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896466

Contacts
Contact: Darryl G Thelen, PhD walkingbalancestudy@gmail.com
Contact: Carrie A Francis, MS

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53706
Contact: Darryl Thelen       dgthelen@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Darryl G Thelen, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01896466     History of Changes
Other Study ID Numbers: 2013-0394
Study First Received: June 10, 2013
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Fall Risk
Gait
Dynamic Balance
Static Balance
Neuromodulation

ClinicalTrials.gov processed this record on September 30, 2014