An interventional study of 1 mo baseline before visual cue in Parkinson's Disease, sponsored by Beth Israel Deaconess Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-14.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
The purpose of this study is to gather data to see if the Laser Cane and/or U-Step Walker with laser accessory is more effective in aiding with gait freezing than a regular cane/U-Step Walker in patients who have idiopathic Parkinson's disease.
Freezing of gait is a significant clinical problem in Parkinson's disease (PD). It interferes with daily functioning and quality of life and often results in falls that potentially can inflict serious injury. In recent years, much more attention has been focused on the clinical characteristics of gait freezing, the severity of falls that can result, and the use of visual cues as a possible treatment in order to understand the implications of episodic freezing. Few clinical studies have been done to confirm the clinical observations to date. The laser cane is a device that has been used and prescribed in movement disorder centers as the only form of treatment for freezing of gait. Although it has been shown to be effective in many cases, there is no published data to support what has been observed in the clinic. The proposed study seeks to clarify unanswered questions regarding the laser cane and its efficacy in aiding with episodic gait freezing and falls.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 mo baseline before visual cue: Cane or walker, no laserlight visual cue x 1 mo; + laserlight visual cue for 2nd mo
Device: 1 mo baseline before visual cue
Cane or walker, no laserlight visual cue x 2 mo, + laserlight visual cue for 3rd mo
Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory
Also known as: U-Step Walking Stabilizer
Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.
The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.
Time frame: 2-3 months
Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature
Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period
Time frame: 2-3 months
Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.
Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue).
Time frame: 2-3 months
Percentage Change in Falls
The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period.
Time frame: 1 to 2 months
All subjects were recruited by movement disorders specialists seen during their clinic visits at either of the 2 participating hospitals
| Milestone | 1 mo Baseline Before Visual Cue | 2 Month Baseline Before Visual Cue |
|---|---|---|
| Started | 16 | 16 |
| Completed | 14 | 12 |
| Not completed | 2 | 4 |
The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.
| change in FOGQ score | 1 Month Baseline Before Use of Laserlight Visual Cue |
|---|---|
| Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score. | 1.25 ± 0.48 |
Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period
| seconds | All Study Participants Who Completed Protocol |
|---|---|
| Before laserlingh visual cue | 65 ± 26.2 |
| With the laserlight visual cue | 57.6 ± 23.3 |
Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue).
| falls per week | All Study Participants Who Completed Protocol |
|---|---|
| without laserlight visual cue | 3.23 ± 1.31 |
| with laserlight visual cue | 2.12 ± 0.92 |
The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period.
| % change in fall frequency | 1 or 2 Month Baseline Before Use of Laserlight Visual Cue |
|---|---|
| Percentage Change in Falls | 39.5 ± 9.3 |
Collected over Average of 6.5 weeks per subject. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Study Participants | — | 0/26 (0%) | 0/26 (0%) |
32 subjects initially signed the consent form, but 6 dropped out prior to any exposure to the laserlight visual cue. Therefore, data in this study are included for the 26 subjects who entered the study and were eventually exposed to the laserlight visual cue.
| Age, Categorical(Participants) | All Study Participants Who Completed Protocol |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 16 |
| Age, Continuous(years) | All Study Participants Who Completed Protocol |
|---|---|
| Mean | 71 (58 to 92) |
| Sex: Female, Male(Participants) | All Study Participants Who Completed Protocol |
|---|---|
| Female | 5 |
| Male | 21 |
| Region of Enrollment(participants) | All Study Participants Who Completed Protocol |
|---|---|
| United States | 26 |
Plan to share: No — Some individual participant data was included in the publication. There is no plan to share additional individual participant data.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beth Israel Deaconess Medical Center