Gait, UnsteadyNCT03579186
OKS for Gait Instability
A study testing OKS in people with Gait, Unsteady and Vestibular Disorder, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Gait, Unsteady, Vestibular Disorder
- What is being tested?
- OKS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2015to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving a gait assessment through the BFC
- Ages 21-75
Who cannot join
- Left hemiparesis
- Requires a cane or walker
- Documented evidence of falls or instability to the left
- Reduced vision
- Moderate or severe dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Optokinetic Stimulation for the Treatment of Gait Abnormalities
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.
Read the 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.
- Conditions
- Gait, Unsteady, Vestibular Disorder
- Being tested
- OKS
- Medical subject headings
- Gait Disorders, Neurologic, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKSDevice
Optokinetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: OKS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait - (measured using a wireless 3D accelerometer)
Change in walking balance (lateral step deviation) as measured using a wireless 3D accelerometer
Measured: 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.
Measured: After 5 minutes of OKS
Secondary outcomes (1)
Speed
Change in gait speed
Measured: After 5 minutes of OKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start19 Jun 2015
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, UnsteadyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Lim, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579186
- Sponsor's protocol ID
- 2015P000091
- Status last verified
- Aug 2021
- First submitted
- 21 Mar 2018
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optokinetic Stimulation for the Treatment of Gait Abnormalities
- ClinicalTrials.gov ID
- NCT03579186
- Acronym / sponsor ID
- 2015P000091
- Conditions
- Gait, Unsteady, Vestibular Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gait | Experimental | Device: OKSPatients 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). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving a gait assessment through the BFC
- Ages 21-75
Key exclusion criteria (5 listed)
- Left hemiparesis
- Requires a cane or walker
- Documented evidence of falls or instability to the left
- Reduced vision
- Moderate or severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKSOptokinetic stimulation | Device | Gait |
Primary outcome
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
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.
1 secondary outcome
Speed
Time frame: After 5 minutes of OKS
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OKS in people with Gait, Unsteady and Vestibular Disorder, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait - (measured using a wireless 3D accelerometer) (time frame: After 5 minutes of OKS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.