Recruiting

Observational Study

Sponsor:

National Institute on Aging (NIA)

Code:

NCT00421759

Conditions

Aging

Somatosensory Deficit

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Vibrating Insoles

Study Details

Brief 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.

Conditions

Aging

Somatosensory Deficit

Study ID

NCT00421759

Start date

Apr, 2006

Status verified date

Aug, 2008

Completion date

Jan, 2009

Anticipated

Primary completion date

Jan, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

85 elderly individuals with somatosensory deficits

experimental: 2

85 elderly individuals with recurrent falls

Interventions

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.

Primary outcome measure

  • Area ellipse of sway [ Time Frame: Three 6-minute trials in one visit, repeated one week later ]
  • Berg Functional Balance Scales [ Time Frame: Three 6-minute trials in one visit, repeated one week later ]
  • Timed Up and Go (TUG)Test [ Time Frame: Three 6-minute trials in one visit, repeated one week later ]
  • Timed one-legged stance test [ Time Frame: Three 6-minute trials in one visit, repeated one week later ]
  • Gait timing variability [ Time Frame: Three 6-minute trials in one visit, repeated one week later ]

Central Contacts and Locations

Central contacts

Ted Gruen

617-363-8554gruen@hrca.harvard.edu

Locations

Applied Biodynamics Laboratory, Boston University

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Attila Priplata, PhD

617-363-8487attilapriplata@hrca.harvard.edu

Principal Investigator:

James Collins, MD

More Information

Sponsor

National Institute on Aging (NIA)

Last update posted

Dec 14, 2009

Last verified

Aug, 2008

Keywords

  • Sensory loss
  • psychomotor function
  • balance
  • gait

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Aging (NIA) on 2009-12-14.