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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03579186
Other study ID # 2015P000091
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 19, 2015
Est. completion date December 12, 2022

Study information

Verified date August 2021
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 12, 2022
Est. primary completion date December 12, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 90 Years
Eligibility 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 Design


Intervention

Device:
OKS
Optokinetic stimulation

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Speed Change in gait speed After 5 minutes of OKS
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