Clinical trial NCT02635113: Falls Prevention: Gait-Synchronized Vibration System
Official title: Falls Prevention Using a Gait-Synchronized Vibration System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sensory Deficits
Keywords: balance
gait
falls
sensory deficits
vibration
visual acuity
dizziness
postural control
proprioceptive function
stereoacuity
depth perception
vestibular dysfunction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2015-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Test the efficacy of a wearable shoe sensor to detect initiation of abnormal gait patterns that increase the likelihood of falls
timeFrame: 1 hour; The entire protocol for testing the PD shoe is expected to be less than 2hours.
Secondary outcomes:
measure: Assess effectiveness of a gait synchronized vibration system to the plantar surface in reducing fall risk.
timeFrame: 1 hour; The entire protocol for testing the PD shoe is expected to be less than 2hours.
Other outcomes:
measure: ABC Confidence Scale
timeFrame: 30 Minutes
measure: Ascertain Dementia 8 (AD8)
timeFrame: 15 Minutes
measure: Balance Master
timeFrame: 15 Minutes
measure: Berg Balance Scale (BBS)
timeFrame: 20 Minutes
measure: Dizziness Handicap Inventory
timeFrame: 15 Minutes
measure: Dynamic Gait Index
timeFrame: 30 Minutes
measure: Gaze Stabilization via the Head Thrust Test
timeFrame: 10 Minutes
measure: Humphrey Visual Field Testing
timeFrame: 10 Minutes
measure: Six Minute Walk Test
timeFrame: 18 Minutes
measure: Short Arthritis Assessment Scale (SAS)
timeFrame: 1 Minute
measure: Snellen Eye Chart
timeFrame: 1 Minute
measure: Timed Up and Go Test
timeFrame: 2 Minutes
measure: Video Documentation
timeFrame: 6 Minutes
Locations:
Study officials:
affiliation: New York University Medical School
name: Preeti Raghavan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: