Trials / Unknown
UnknownNCT00421759
Noise-Enhanced Sensory Function in Elders at Risk for Falls
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- Sponsor
- National Institute on Aging (NIA) · NIH
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
The long-term goal of this project is to develop a non-invasive, noise-based technique for enhancing somatosensation and thereby improving balance control in elderly fallers and older adults with somatosensory deficits.
Detailed description
Previous studies have shown that sub-sensory mechanical noise (i.e., random vibration with a small intensity) can enhance somatosensory function in healthy individuals and older adults with somatosensory deficits. Moreover, the postural sway of both healthy young and healthy elderly individuals during quiet standing can be significantly reduced by applying sub-sensory mechanical noise to the feet using vibrating shoe insoles. The specific aims of this project are to determine the effects of noise-enhanced somatosensation at the feet on balance performance in elderly individuals with somatosensory deficits and/or recurrent falls, and to assess whether adaptation occurs in noise-enhanced balance control in these individuals. To accomplish these aims, quiet-standing and dynamic posture studies and clinical balance assessments will be conducted on elderly individuals with somatosensory deficits and elderly individuals with recurrent falls (two or more falls over a 12-month period). This project could lead to the development of a novel bioengineering technique for improving balance control in older adults and patients with somatosensory deficits. The work could thus serve to reduce the frequency, morbidity and cost of falling, and assist aged individuals in achieving maximal independence in activities of daily living and mobility. Two groups of participants will be recruited from the RNH Epidemiology Core: 85 elderly individuals with somatosensory deficits, and 85 elderly individuals with recurrent falls. The study consists of three visits--a one-hour neurological exam, and two 6-hour laboratory testing sessions scheduled one week apart.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vibrating Insoles | Participants wear vibrating sandals for 3 trials of 6 minutes, during a single lab visit. The sandal vibration is on during either first or second 3 minutes of the 6 minute trial, as they walk. Also, participants wear the sandals for 2 hours while sitting, with vibrations on for one visit and off for the other. |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2009-01-01
- Completion
- 2009-01-01
- First posted
- 2007-01-12
- Last updated
- 2009-12-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00421759. Inclusion in this directory is not an endorsement.