Noise-Enhanced Sensory Function in Elders at Risk for Falls - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00421759

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	Phase
Aging Somatosensory Deficit	Device: Vibrating Insoles	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Noise-Enhanced Sensory Function in Elders at Risk for Falls

Resource links provided by NLM:

MedlinePlus related topics: Noise

U.S. FDA Resources

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
1: Experimental 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.
2: Experimental 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

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

National Institute on Aging (NIA)

More Information

Publications:

Priplata AA, Niemi JB, Harry JD, Lipsitz LA, Collins JJ. Vibrating insoles and balance control in elderly people. Lancet. 2003 Oct 4;362(9390):1123-4.

Kiemel T, Oie KS, Jeka JJ. Multisensory fusion and the stochastic structure of postural sway. Biol Cybern. 2002 Oct;87(4):262-77.

Laughton CA, Slavin M, Katdare K, Nolan L, Bean JF, Kerrigan DC, Phillips E, Lipsitz LA, Collins JJ. Aging, muscle activity, and balance control: physiologic changes associated with balance impairment. Gait Posture. 2003 Oct;18(2):101-8.

Liu W, Lipsitz LA, Montero-Odasso M, Bean J, Kerrigan DC, Collins JJ. Noise-enhanced vibrotactile sensitivity in older adults, patients with stroke, and patients with diabetic neuropathy. Arch Phys Med Rehabil. 2002 Feb;83(2):171-6.

Priplata A, Niemi J, Salen M, Harry J, Lipsitz LA, Collins JJ. Noise-enhanced human balance control. Phys Rev Lett. 2002 Dec 2;89(23):238101. Epub 2002 Nov 13.

Responsible Party:	Applied Biodynamics Laboratory, Boston University ( Hyun Gu Kang, PhD )
Study ID Numbers:	AG0072, 5P01AG004390-230014
Study First Received:	January 10, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00421759 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Sensory loss
psychomotor function
balance
gait

ClinicalTrials.gov processed this record on November 09, 2009