OKS for Gait Instability

December 12, 2022 updated by: Chun Lim, Beth Israel Deaconess Medical Center

Optokinetic Stimulation for the Treatment of Gait Abnormalities

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gait
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
Optokinetic stimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2015

Primary Completion (Actual)

December 12, 2022

Study Completion (Actual)

December 12, 2022

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P000091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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