Falls Prevention: Gait-Synchronized Vibration System

NYU Langone Health

Status: Withdrawn

Conditions: Sensory Deficits

Treatments: Device: Gait Synchronized Vibration System

Study type: Interventional

Funder types: Other

Identifiers

NCT02635113

13-00617

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PD Shoe

Experimental group

Description:

40 subjects will wear the shoe in order to test abnormal gait patterns that increase likelihood of falls and the effectiveness of a gait synchronized vibration system to plantar surface to reduce fall risk.

Treatment:

Device: Gait Synchronized Vibration System