Parkinson DiseasePhase 3NCT01502995
Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
A Phase 3 study testing Laser light (U-Step Walking Stabilizer with laser light) in people with Parkinson Disease, run by Parkinson's Disease Research, Education, and Clinical Center, Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Laser light (U-Step Walking Stabilizer with laser light)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Apr 2005
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- idiopathic PD confirmed by a movement disorders neurologist
- a Mini-Mental Status Examination (MMSE)[13] score ≥ 24 to ensure competence to participate in informed consent and an ability to learn procedurally the use of the rolling walker with laser beam
- functional visual acuity for recognizing the laser beam on the rolling walker
- FOG in both on and off medication states, as indicated by a score of ≥ 2 on Item 14 of the Unified Parkinson's Disease Rating Scale (UPDRS) and/or ≥1 on Item 3 of the Freezing of Gait Questionnaire (FOGQ)
- ability to ambulate for at least household distances with or without an assistive device as indicated by scoring 0, 1, or 2 on Items 15 and 29 of the UPDRS.
Who cannot join
- diagnosis of a gait disorder other than Parkinson's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia VA Medical Center PADRECC
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's disease.
Read the detailed description
Freezing of gait is a debilitating feature of Parkinson's disease. This study aims to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes. Patients will perform two trials of 3 timed walking tasks: once with the laser beam and once without. For each trial, the time to complete, number of steps, and number of freezing episodes will be recorded. Patients will be randomized to perform the first trial either with the light or without the light, to control for fatigue.
- Conditions
- Parkinson Disease
- Being tested
- Laser light (U-Step Walking Stabilizer with laser light)
- Keywords
- Assistive devices, Freezing of gait, Gait disorders, Gait hesitation, Gait ignition failure, Laser light, Parkinson's disease, Rolling walker, Visual Cue, Walker
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser light (U-Step Walking Stabilizer with laser light)Device
Also called U-Step Walking Stabilizer with laser light
Use of a laser light on a rolling walker during episodes of freezing of gait.
| Study group | Role | What they receive |
|---|---|---|
| With laser light | Active comparator | Trial of walking tasks using laser light on walker. Receives: Device: Laser light (U-Step Walking Stabilizer with laser light) |
| Without laser light | Active comparator | Trial of walking task without laser light on walker. Receives: Device: Laser light (U-Step Walking Stabilizer with laser light) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete walking task
Time in seconds for subject to complete the designated walking task.
Measured: Two hours
Secondary outcomes (2)
Number of steps
Number of steps taken to complete the designated walking task.
Measured: Two hours
Number of freezing episodes
Number of freezing episodes that occur during walking task.
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startJun 2003
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisette Bunting-Perry, PhD, RN, Principal investigator, Philadelphia VAMC PADRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502995
- Sponsor's protocol ID
- 00583
- Status last verified
- Dec 2011
- First submitted
- 21 Dec 2011
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01502995
- Acronym / sponsor ID
- 00583
- Conditions
- Parkinson Disease
- Keywords
- Assistive devices, Freezing of gait, Gait disorders, Gait hesitation, Gait ignition failure, Laser light, Parkinson's disease, Rolling walker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Parkinson's Disease Research, Education, and Clinical Center, PhiladelphiaUS federal agency
- Study start
- Jun 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 2 Jan 2012 (estimated)
- 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.
The purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's disease.
Detailed description
Freezing of gait is a debilitating feature of Parkinson's disease. This study aims to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes. Patients will perform two trials of 3 timed walking tasks: once with the laser beam and once without. For each trial, the time to complete, number of steps, and number of freezing episodes will be recorded. Patients will be randomized to perform the first trial either with the light or without the light, to control for fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With laser light | Active comparator | Device: Laser light (U-Step Walking Stabilizer with laser light)Trial of walking tasks using laser light on walker. |
| Without laser light | Active comparator | Device: Laser light (U-Step Walking Stabilizer with laser light)Trial of walking task without laser light on walker. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- idiopathic PD confirmed by a movement disorders neurologist
- a Mini-Mental Status Examination (MMSE)[13] score ≥ 24 to ensure competence to participate in informed consent and an ability to learn procedurally the use of the rolling walker with laser beam
- functional visual acuity for recognizing the laser beam on the rolling walker
- FOG in both on and off medication states, as indicated by a score of ≥ 2 on Item 14 of the Unified Parkinson's Disease Rating Scale (UPDRS) and/or ≥1 on Item 3 of the Freezing of Gait Questionnaire (FOGQ)
- ability to ambulate for at least household distances with or without an assistive device as indicated by scoring 0, 1, or 2 on Items 15 and 29 of the UPDRS.
Key exclusion criteria (1 listed)
- diagnosis of a gait disorder other than Parkinson's disease
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 |
|---|---|---|
| Laser light (U-Step Walking Stabilizer with laser light)Also: U-Step Walking Stabilizer with laser lightUse of a laser light on a rolling walker during episodes of freezing of gait. | Device | With laser light, Without laser light |
Primary outcome
Time to complete walking task
Time frame: Two hours
Time in seconds for subject to complete the designated walking task.
2 secondary outcomes
Number of steps
Time frame: Two hours
Number of freezing episodes
Time frame: Two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2012.
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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.
Lisette Bunting-Perry, PhD, RN principal investigator
Philadelphia VAMC PADRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laser light (U-Step Walking Stabilizer with laser light) in people with Parkinson Disease, run by Parkinson's Disease Research, Education, and Clinical Center, Philadelphia 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 2 Jan 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to complete walking task (time frame: Two hours). 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 2 Jan 2012.