OKS for Gait Instability | NCT03579186

Studies
OKS for Gait Instability

NCT03579186

Sponsor

Beth Israel Deaconess Medical Center

Status

Withdrawn

Last Update Posted

Dec 13, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Gait, Unsteady
Vestibular Disorder

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval

Expanded Access Info

Start Date

Jun 19, 2015Actual

Primary Completion Date

Dec 12, 2022Actual

Completion Date

Dec 12, 2022Actual

First Submitted Date

Mar 21, 2018

First Submission Date that Met QC Criteria

Jul 3, 2018

First Posted Date

Jul 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2022

Last Update Posted Date

Dec 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chun Lim, Assistant Professor, Beth Israel Deaconess Medical CenterPrincipal Investigator

Lead Sponsor

Beth Israel Deaconess Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Specific aim: To determine whether optokinetic stimulation can improve gait abnormalities.

Hypothesis: Optokinetic stimulation stimulates the vestibular system and can improve vestibular induced gait disorders.

Detailed Description

This is a pilot study designed to determine whether or not the optokinetic stimulation improves gait in patients with gait abnormalities, specifically vestibular induced gait disorders. The study population will consist of patients already receiving a gait assessment through the Brain Fit Club (BFC) at Beth Israel Deaconess Medical Center. This gait assessment involves walking and posture evaluations. Patients will complete a gait assessment as part of their normal BFC evaluation. Those who consent to participate in the study will then complete a gait assessment while receiving optokinetic stimulation. The investigators will compare baseline gait and postural control before and during OKS stimulation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gait	Experimental	Patients undergoing a routine clinical gait assessment at the Brain Fit Club at BIDMC will have their posture and gait measured before and during optokinetic stimulation (OKS).	Device: OKS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OKS	Device	Optokinetic stimulation	Gait

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gait - (measured using a wireless 3D accelerometer)	Change in walking balance (lateral step deviation) as measured using a wireless 3D accelerometer	After 5 minutes of OKS
Posture - (measured using a stationary force platform)	Change in standing balance (left-right deviation) as measured using a stationary force platform.	After 5 minutes of OKS

Secondary Outcomes

Measure	Description	Time Frame
Speed	Change in gait speed	After 5 minutes of OKS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Receiving a gait assessment through the BFC
Ages 21-75

Exclusion criteria:

Left hemiparesis
Requires a cane or walker
Documented evidence of falls or instability to the left
Reduced vision
Moderate or severe dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02215	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020233	Gait Disorders, Neurologic
D015837	Vestibular Diseases

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Patients undergoing a clinical gait assessment will be recruited for this study. Those that consent to participate will complete their clinical gait assessment as part of their normal evaluation. Subjects will then complete a gait assessment while wearing experiencing optokinetic stimulation. The investigators will compare baseline gait and postural control before and during OKS stimulation.