AgingNCT00421759
Noise-Enhanced Sensory Function in Elders at Risk for Falls
A study testing Vibrating Insoles in people with Aging and Somatosensory Deficit, run by National Institute on Aging (NIA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aging, Somatosensory Deficit
- What is being tested?
- Vibrating Insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Applied Biodynamics Laboratory, Boston University
Boston, Massachusetts, 02215
Attila Priplata, PhD, 617-363-8487, attilapriplata@hrca.harvard.edu
James Collins, MD
About this study
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.
Read the 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
- Aging, Somatosensory Deficit
- Being tested
- Vibrating Insoles
- Keywords
- Sensory loss, psychomotor function, balance, gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating InsolesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 85 elderly individuals with somatosensory deficits Receives: Device: Vibrating Insoles |
| 2 | Experimental | 85 elderly individuals with recurrent falls Receives: Device: Vibrating Insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area ellipse of sway
Measured: Three 6-minute trials in one visit, repeated one week later
Berg Functional Balance Scales
Measured: Three 6-minute trials in one visit, repeated one week later
Timed Up and Go (TUG)Test
Measured: Three 6-minute trials in one visit, repeated one week later
Timed one-legged stance test
Measured: Three 6-minute trials in one visit, repeated one week later
Gait timing variability
Measured: Three 6-minute trials in one visit, repeated one week later
Secondary outcomes (2)
Changes in: stabilogram-diffusion analysis (SDA)
Measured: Three 6-minute trials in one visit, repeated one week later
Neurological risk factors related to falls
Measured: Three 6-minute trials in one visit, repeated one week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startApr 2006
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421759
- Sponsor's protocol ID
- AG0072
- Other IDs
- 5P01AG004390-230014, 5P01AG004390
- Status last verified
- Aug 2008
- First submitted
- 10 Jan 2007
- Last updated
- 14 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/S0140-6736(03)14470-4.
PubMed 14550702Kiemel T, Oie KS, Jeka JJ. Multisensory fusion and the stochastic structure of postural sway. Biol Cybern. 2002 Oct;87(4):262-77. doi: 10.1007/s00422-002-0333-2.
PubMed 12386742Laughton 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. doi: 10.1016/s0966-6362(02)00200-x.
PubMed 14654213Liu 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. doi: 10.1053/apmr.2002.28025.
PubMed 11833019Priplata 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. doi: 10.1103/PhysRevLett.89.238101. Epub 2002 Nov 13.
PubMed 12485044
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noise-Enhanced Sensory Function in Elders at Risk for Falls
- ClinicalTrials.gov ID
- NCT00421759
- Acronym / sponsor ID
- AG0072
- Conditions
- Aging, Somatosensory Deficit
- Keywords
- Sensory loss, psychomotor function, balance, gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Apr 2006
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 12 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Vibrating Insoles85 elderly individuals with somatosensory deficits |
| 2 | Experimental | Device: Vibrating Insoles85 elderly individuals with recurrent falls |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrating InsolesParticipants 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. | Device | 1, 2 |
Primary outcome
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
2 secondary outcomes
Changes in: stabilogram-diffusion analysis (SDA)
Time frame: Three 6-minute trials in one visit, repeated one week later
Neurological risk factors related to falls
Time frame: Three 6-minute trials in one visit, repeated one week later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2009.
- Background: PubMed 14550702Priplata 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. doi: 10.1016/S0140-6736(03)14470-4.
- Background: PubMed 12386742Kiemel T, Oie KS, Jeka JJ. Multisensory fusion and the stochastic structure of postural sway. Biol Cybern. 2002 Oct;87(4):262-77. doi: 10.1007/s00422-002-0333-2.
- Background: PubMed 14654213Laughton 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. doi: 10.1016/s0966-6362(02)00200-x.
- Background: PubMed 11833019Liu 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. doi: 10.1053/apmr.2002.28025.
- Background: PubMed 12485044Priplata 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. doi: 10.1103/PhysRevLett.89.238101. Epub 2002 Nov 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating Insoles in people with Aging and Somatosensory Deficit, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ted Gruen (617-363-8554, gruen@hrca.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area ellipse of sway (time frame: Three 6-minute trials in one visit, repeated one week later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00421759, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2009.