Falls Prevention: Gait-Synchronized Vibration System
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 10/11/2018 |
| Start Date: | December 2018 |
| End Date: | February 2019 |
| Contact: | Olanta Chandler |
| Email: | olanta.chandler@nyumc.org |
| Phone: | 212-263-8044 |
Falls Prevention Using a Gait-Synchronized Vibration System
The purpose of this study is to develop an abnormal gait detection algorithm and a vibratory
stimulation system on a lower limb to improve gait stability and prevent falls. The
investigators want to detect, assess and communicate fall risk indicators obtained via the
shoe sensors, and assess effectiveness of a gait synchronized vibration system to the plantar
surface in reducing fall risk.The system consists of a gait measurement module, an abnormal
gait detection module, and a vibratory stimulation module.
stimulation system on a lower limb to improve gait stability and prevent falls. The
investigators want to detect, assess and communicate fall risk indicators obtained via the
shoe sensors, and assess effectiveness of a gait synchronized vibration system to the plantar
surface in reducing fall risk.The system consists of a gait measurement module, an abnormal
gait detection module, and a vibratory stimulation module.
Forty (40) Individuals with decreased confidence in ambulatory scores (<80%) as per the
Activities Specific Balance Confidence questionnaire, will undergo functional assessments for
visual (Snellen chart, Humphrey Visual Field Testing, Gaze Stabilization test, depth
perception evaluation), vestibular (Dizziness Handicap Inventory, Head Thrust test) and
proprioceptive (Balance Master, Berg Balance Scale, Joint Position Sense) impairments, to
evaluate factors which might contribute to increased falls risk.
Participants will be asked to walk return for a second visit and to walk with a shoe sensor
and gait synchronized vibratory stimulus under conditions of (1) Baseline performance on the
Six Minute Walk test (2) Performance on the Six Minute Walk test and Dynamic Gait Index
without vibratory stimulus (3) Performance on the Six Minute Walk test and Dynamic Gait Index
with vibratory stimulus.
Activities Specific Balance Confidence questionnaire, will undergo functional assessments for
visual (Snellen chart, Humphrey Visual Field Testing, Gaze Stabilization test, depth
perception evaluation), vestibular (Dizziness Handicap Inventory, Head Thrust test) and
proprioceptive (Balance Master, Berg Balance Scale, Joint Position Sense) impairments, to
evaluate factors which might contribute to increased falls risk.
Participants will be asked to walk return for a second visit and to walk with a shoe sensor
and gait synchronized vibratory stimulus under conditions of (1) Baseline performance on the
Six Minute Walk test (2) Performance on the Six Minute Walk test and Dynamic Gait Index
without vibratory stimulus (3) Performance on the Six Minute Walk test and Dynamic Gait Index
with vibratory stimulus.
Inclusion Criteria:
1. Individuals aged 65 or greater.
2. Low balance confidence (scores <80%) on the ABC Balance Confidence Scale
3. Berg Balance Scale (BBS) scores between 21 (moderate fall risk) and 56 (low fall
risk).
Exclusion Criteria:
1. No internal implantable device (i.e. Pacemaker, Intrathecal Baclofen Pump)
2. Significant painful arthritis (scores 15 or greater) as per the Short Arthritis
Assessment Scale.
3. Significant cognitive deficits (scores <2) as per Ascertain Dementia 8 (AD8)
questionnaire.
4. Significant visual field deficits as per the Humphrey Visual Field Analysis or
significant uncorrected visual acuity deficits as per the Snellen Eye Chart.
5. Current treatment with anticoagulation medication
6. Parkinson's Disease or known Peripheral Neuropathy
7. Limitations to exercise related to cardiac, neurological or pulmonary diseases
8. Orthostatic hypotension
9. Severe osteoporosis defined by fracture history, BMD by DEXA (T score more than 2.5
standard deviations below controls in the last 2 years), or height loss of more than 3
cm
10. Current treatment with corticosteroids or aromatase inhibitor
11. Current treatment with seizure medication
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Phone: 212-598-6206
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