Enhanced Gait and Balance Training

Aging Clinical Trial

Official title:

Influence of Neuromodulation on Gait and Balance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896466
• Other study ID #: 2013-0394
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Accidental Falls
• Aging

Intervention

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.

Behavioral:
• Sham Cranial Nerve Non-Invasive Neuromodulation
Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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