Falls Prevention: Gait-Synchronized Vibration System

Not Applicable

Withdrawn

• Conditions: Sensory Deficits
• Interventions: Device: Gait Synchronized Vibration System

• Registration Number: NCT02635113
• Lead Sponsor: NYU Langone Health

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-18
• Study Start: 2017-11-30
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD Shoe	Gait Synchronized Vibration System	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.

Primary Outcome Measures

Name	Time	Method
Test the efficacy of a wearable shoe sensor to detect initiation of abnormal gait patterns that increase the likelihood of falls	1 hour; The entire protocol for testing the PD shoe is expected to be less than 2hours.	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.

Secondary Outcome Measures

Name	Time	Method
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.	Investigators will measure the change in gait parameters (cadence, velocity, stride and step lengths) and performance on the Dynamic Gait Index with and without vibratory stimulus.