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OKS for Gait Instability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579186
Recruitment Status : Suspended (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)
First Posted : July 6, 2018
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

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.


Condition or disease Intervention/treatment Phase
Gait, Unsteady Vestibular Disorder Device: OKS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Optokinetic Stimulation for the Treatment of Gait Abnormalities
Actual Study Start Date : June 19, 2015
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

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




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Speed [ Time Frame: After 5 minutes of OKS ]
    Change in gait speed



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579186


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03579186    
Other Study ID Numbers: 2015P000091
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vestibular Diseases
Gait Disorders, Neurologic
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms