Noise-Enhanced Sensory Function in Elders at Risk for Falls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00421759
First received: January 10, 2007
Last updated: December 10, 2009
Last verified: August 2008

January 10, 2007
December 10, 2009
April 2006
January 2009   (final data collection date for primary outcome measure)
  • Area ellipse of sway [ Time Frame: Three 6-minute trials in one visit, repeated one week later ] [ Designated as safety issue: No ]
  • Berg Functional Balance Scales [ Time Frame: Three 6-minute trials in one visit, repeated one week later ] [ Designated as safety issue: No ]
  • Timed Up and Go (TUG)Test [ Time Frame: Three 6-minute trials in one visit, repeated one week later ] [ Designated as safety issue: No ]
  • Timed one-legged stance test [ Time Frame: Three 6-minute trials in one visit, repeated one week later ] [ Designated as safety issue: No ]
  • Gait timing variability [ Time Frame: Three 6-minute trials in one visit, repeated one week later ] [ Designated as safety issue: No ]
  • Changes in: area ellipse of sway
  • Berg Functional Balance Scales
  • Timed Up and Go (TUG)Test
  • timed one-legged stance test
Complete list of historical versions of study NCT00421759 on ClinicalTrials.gov Archive Site
  • Changes in: stabilogram-diffusion analysis (SDA) [ Time Frame: Three 6-minute trials in one visit, repeated one week later ] [ Designated as safety issue: No ]
  • Neurological risk factors related to falls [ Time Frame: Three 6-minute trials in one visit, repeated one week later ] [ Designated as safety issue: No ]
  • Changes in: stabilogram-diffusion analysis (SDA)
  • neurological risk factors related to falls
Not Provided
Not Provided
 
Noise-Enhanced Sensory Function in Elders at Risk for Falls
Noise-Enhanced Sensory Function in Elders at Risk for Falls

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Aging
  • Somatosensory Deficit
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.
  • Experimental: 1
    85 elderly individuals with somatosensory deficits
    Intervention: Device: Vibrating Insoles
  • Experimental: 2
    85 elderly individuals with recurrent falls
    Intervention: Device: Vibrating Insoles

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant must (1) have somatosensory deficit (mild to moderate sensory loss on the bottom of both feet) OR (2) be classified as a recurrent faller (two or more incident falls over a twelve-month period not related to syncope, major medical events, or overwhelming external hazards)
  • Age 70 and older
  • Able to stand unassisted for at least 60 seconds several times over a 30-minute period
  • Able to walk without assistance from a walking aid

Exclusion Criteria:

  • Known history of seizures or fainting
  • Unstable medical condition
  • Open lesions or poor skin condition on feet
  • Unable to cooperate with or understand the protocol
  • Foot size larger or smaller than the constructed vibrating insoles (men's sizes smaller than 3 or larger than 12; women's sizes smaller than 4.5 or larger than 13.5)
Both
70 Years and older
No
Contact: Ted Gruen 617-363-8554 gruen@hrca.harvard.edu
United States
 
NCT00421759
AG0072, 5P01AG004390-230014
Yes
Hyun Gu Kang, PhD, Applied Biodynamics Laboratory, Boston University
National Institute on Aging (NIA)
Not Provided
Not Provided
National Institute on Aging (NIA)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP