Enhanced Gait and Balance Training
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | December 2015 |
| Contact: | Darryl G Thelen, PhD |
| Email: | walkingbalancestudy@gmail.com |
Influence of Neuromodulation on Gait and Balance
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.
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.
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
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
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