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The purpose of this study is twofold:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Healthy Older Adults - Control | Active Comparator | Healthy subjects between age 65+ will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training. |
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| Healthy Older Adults - Intervention | Active Comparator | Healthy subjects age 65+ will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Darryl G Thelen, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53706 | United States |
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| 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. |
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| Sham Cranial Nerve Non-Invasive Neuromodulation | Behavioral | Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels. |
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