Falls Prevention: Gait-Synchronized Vibration System

NCT02635113 | Withdrawn

• 1 other identifier: 13-00617
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sensory Deficits

Keywords

balance; gait; falls; sensory deficits; vibration; visual acuity; dizziness; postural control; proprioceptive function; stereoacuity; depth perception; vestibular dysfunction

Outcome Measures

Primary Outcomes (1)

• Test the efficacy of a wearable shoe sensor to detect initiation of abnormal gait patterns that increase the likelihood of falls

  Investigators will use pearson's correlation tests on gait variables (cadence, velocity, stride and step lengths) on Dynamic Gait Index that correlate with visual, proprioceptive and vestibular impairments and functional indicators of fall risk (e.g., Berg Balance Scale, Dynamic Gait Index, Activities Specific Balance Confidence questionnaire, Dizziness Handicap Inventory, Gaze Stabilization and Head Thrust Test) to determine variables that indicate an increased likelihood of falls.

  1 hour; The entire protocol for testing the PD shoe is expected to be less than 2hours.

Secondary Outcomes (1)

• Assess effectiveness of a gait synchronized vibration system to the plantar surface in reducing fall risk.

  1 hour; The entire protocol for testing the PD shoe is expected to be less than 2hours.

Other Outcomes (13)

• ABC Confidence Scale

  30 Minutes

• Ascertain Dementia 8 (AD8)

  15 Minutes

• Balance Master

  15 Minutes

Study Arms (1)

PD Shoe

EXPERIMENTAL

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.

Device: Gait Synchronized Vibration System

Interventions

Gait Synchronized Vibration System DEVICE

A wearable vibratory shoe that delivers stimulus to the soles that is synchronized with step resulting in improved gait.The shoe consists of two externally mounted vibration units (tactors). The vibration units allow for variation of both frequency and amplitude of stimulation independently. Using the pressure sensors and timing data, gait velocity, cadence, swing time, stance phase and double support time will be analyzed to assess features of their gait performance during the Dynamic Gait Index with and without vibratory stimuli.

Also known as: PD shoes

PD Shoe

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Individuals aged 65 or greater.
• Low balance confidence (scores \<80%) on the ABC Balance Confidence Scale
• Berg Balance Scale (BBS) scores between 21 (moderate fall risk) and 56 (low fall risk).

You may not qualify if:

• No internal implantable device (i.e. Pacemaker, Intrathecal Baclofen Pump)
• Significant painful arthritis (scores 15 or greater) as per the Short Arthritis Assessment Scale.
• Significant cognitive deficits (scores \<2) as per Ascertain Dementia 8 (AD8) questionnaire.
• Significant visual field deficits as per the Humphrey Visual Field Analysis or significant uncorrected visual acuity deficits as per the Snellen Eye Chart.
• Current treatment with anticoagulation medication
• Parkinson's Disease or known Peripheral Neuropathy
• Limitations to exercise related to cardiac, neurological or pulmonary diseases
• Orthostatic hypotension
• 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
• Current treatment with corticosteroids or aromatase inhibitor
• Current treatment with seizure medication

Sponsors & Collaborators

• NYU Langone Health: lead
• Columbia University: collaborator

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Preeti Raghavan, M.D.

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: November 30, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share