NCT03579186

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

December 13, 2022

Status Verified

August 1, 2021

Enrollment Period

7.5 years

First QC Date

March 21, 2018

Last Update Submit

December 12, 2022

Conditions

Gait, UnsteadyVestibular Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Speed

    After 5 minutes of OKS

Study Arms (1)

Gait

EXPERIMENTAL

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

Interventions

OKSDEVICE

Optokinetic stimulation

Gait

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving a gait assessment through the BFC
  • Ages 21-75

You may not qualify if:

  • Left hemiparesis
  • Requires a cane or walker
  • Documented evidence of falls or instability to the left
  • Reduced vision
  • Moderate or severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Gait Disorders, NeurologicVestibular Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2018

First Posted

July 6, 2018

Study Start

June 19, 2015

Primary Completion

December 12, 2022

Study Completion

December 12, 2022

Last Updated

December 13, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)