Falls Prevention: Gait-Synchronized Vibration System

NCT ID: NCT02635113

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2018-11-30

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.

Conditions

Sensory Deficits

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PD Shoe

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.

Group Type: EXPERIMENTAL

Gait Synchronized Vibration System

Intervention Type: 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.

Interventions

Gait Synchronized Vibration System

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.

Intervention Type: DEVICE

Other Intervention Names

PD shoes

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Preeti Raghavan, M.D.

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Other Identifiers

13-00617

Identifier Type: -

Identifier Source: org_study_id