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OKS for Gait Instability

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03579186
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
86.4
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: OKS
 N/A

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 Design

Study Type:
Interventional
Anticipated 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.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 :
Jun 19, 2015
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Gait - (measured using a wireless 3D accelerometer) [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) [After 5 minutes of OKS]

    Change in standing balance (left-right deviation) as measured using a stationary force platform.

Secondary Outcome Measures

  1. Speed [After 5 minutes of OKS]

    Change in gait speed

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Beth Israel Deaconess Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chun Lim, Assistant Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT03579186
Other Study ID Numbers:
  • 2015P000091
First Posted:
Jul 6, 2018
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vestibular Diseases
Gait Disorders, Neurologic

Study Results

No Results Posted as of Aug 25, 2021