Enhanced Gait and Balance Training

University of Wisconsin (UW)

Status: Completed

Conditions: Aging; Accidental Falls

Treatments: Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation; Device: Cranial Nerve Non-Invasive Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01896466

2013-0394

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 6 patient groups

Young Adults - Intervention

Active Comparator group

Description:

Healthy subjects between the ages of 18-39 will participate in Cranial Nerve Non-Invasive Neuromodulation gait and balance training.

Treatment:

Device: Cranial Nerve Non-Invasive Neuromodulation

Healthy Older Adults - Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation

Healthy Older Adults - Intervention

Active Comparator group

Description:

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

Treatment:

Device: Cranial Nerve Non-Invasive Neuromodulation

Older Fallers - Control

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation

Older Fallers - Intervention

Experimental group

Description:

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.

Treatment:

Device: Cranial Nerve Non-Invasive Neuromodulation

Young Adult - Control

Active Comparator group

Description:

Healthy subjects between the ages of 18-39 will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training.

Treatment:

Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation