Trial record 8 of 16 for:    Open Studies | "Noise"

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
  Purpose

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.


Condition Intervention
Aging
Somatosensory Deficit
Device: Vibrating Insoles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Noise-Enhanced Sensory Function in Elders at Risk for Falls

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 170
Study Start Date: April 2006
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
85 elderly individuals with somatosensory deficits
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: 2
85 elderly individuals with recurrent falls
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.

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421759

Contacts
Contact: Ted Gruen 617-363-8554 gruen@hrca.harvard.edu

Locations
United States, Massachusetts
Applied Biodynamics Laboratory, Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Attila Priplata, PhD    617-363-8487    attilapriplata@hrca.harvard.edu   
Principal Investigator: James Collins, MD         
Sponsors and Collaborators