OKS for Gait Instability
Primary Purpose
Gait, Unsteady, Vestibular Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OKS
Sponsored by
About this trial
This is an interventional device feasibility trial for Gait, Unsteady
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gait
Arm Description
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).
Outcomes
Primary Outcome Measures
Gait - (measured using a wireless 3D accelerometer)
Change in walking balance (lateral step deviation) as measured using a wireless 3D accelerometer
Posture - (measured using a stationary force platform)
Change in standing balance (left-right deviation) as measured using a stationary force platform.
Secondary Outcome Measures
Speed
Change in gait speed
Full Information
NCT ID
NCT03579186
First Posted
March 21, 2018
Last Updated
December 12, 2022
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03579186
Brief Title
OKS for Gait Instability
Official Title
Optokinetic Stimulation for the Treatment of Gait Abnormalities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
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
Study Start Date
June 19, 2015 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady, Vestibular Disorder
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gait
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
OKS
Intervention Description
Optokinetic stimulation
Primary Outcome Measure Information:
Title
Gait - (measured using a wireless 3D accelerometer)
Description
Change in walking balance (lateral step deviation) as measured using a wireless 3D accelerometer
Time Frame
After 5 minutes of OKS
Title
Posture - (measured using a stationary force platform)
Description
Change in standing balance (left-right deviation) as measured using a stationary force platform.
Time Frame
After 5 minutes of OKS
Secondary Outcome Measure Information:
Title
Speed
Description
Change in gait speed
Time Frame
After 5 minutes of OKS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
OKS for Gait Instability
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