Sensory DeficitsNCT02635113
Falls Prevention: Gait-Synchronized Vibration System
A study testing Gait Synchronized Vibration System in people with Sensory Deficits, run by NYU Langone Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensory Deficits
- What is being tested?
- Gait Synchronized Vibration System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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
About this study
Official title: Falls Prevention Using a Gait-Synchronized Vibration System
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.
Read the 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
- Being tested
- Gait Synchronized Vibration System
- Keywords
- balance, gait, falls, sensory deficits, vibration, visual acuity, dizziness, postural control, proprioceptive function, stereoacuity, depth perception, vestibular dysfunction
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Synchronized Vibration SystemDevice
Also called PD shoes
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Gait Synchronized Vibration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1 hour; The entire protocol for testing the PD shoe is expected to be less than 2hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study start30 Nov 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory DeficitsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Preeti Raghavan, M.D., Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635113
- Sponsor's protocol ID
- 13-00617
- Status last verified
- Jan 2019
- First submitted
- 16 Dec 2015
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study has been withdrawn
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falls Prevention Using a Gait-Synchronized Vibration System
- ClinicalTrials.gov ID
- NCT02635113
- Acronym / sponsor ID
- 13-00617
- Conditions
- Sensory Deficits
- Keywords
- balance, gait, falls, sensory deficits, vibration, visual acuity, dizziness, postural control
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD Shoe | Experimental | Device: Gait Synchronized Vibration System40 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Synchronized Vibration SystemAlso: PD shoesA 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. | Device | PD Shoe |
Primary outcome
Test the efficacy of a wearable shoe sensor to detect initiation of abnormal gait patterns that increase the likelihood of falls
Time frame: 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.
1 secondary outcome
Assess effectiveness of a gait synchronized vibration system to the plantar surface in reducing fall risk.
Time frame: 1 hour; The entire protocol for testing the PD shoe is expected to be less than 2hours.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No. Study has been withdrawn
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preeti Raghavan, M.D. principal investigator
New York University Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Gait Synchronized Vibration System in people with Sensory Deficits, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test the efficacy of a wearable shoe sensor to detect initiation of abnormal gait patterns that increase the likelihood of falls (time frame: 1 hour; The entire protocol for testing the PD shoe is expected to be less than 2hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.