Parkinson's Disease
Conditions
Keywords
Parkinson's disease, laser cane, freezing of gait, visual cues
Brief summary
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.
Detailed description
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.
Interventions
DEVICE1 mo baseline before visual cue
Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects or a designated proxy have given informed consent * Subject has been diagnosed with idiopathic Parkinson's disease * Subject is ambulatory. If a wheelchair is used part-time, it must be used for less than 50% of the time * Positive assessment for Questionnaire Used to Identify Freezing of Gait in PD Patients at subject's best on
Exclusion criteria
* Presence of atypical features suggestive of MSA, PSP, ataxia, unexplained or prominent pyramidal signs, and/or autonomic dysfunction * Subjects who are non-ambulatory more than 50% of the time * Subjects who have had a history of syncope in the 6 months prior to screening * Subjects with moderate or advanced dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score. | 2-3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature | 2-3 months | 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 |
| Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue. | 2-3 months | 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). |
| Percentage Change in Falls | 1 to 2 months | 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. |
Countries
United States
Participant flow
Recruitment details
All subjects were recruited by movement disorders specialists seen during their clinic visits at either of the 2 participating hospitals
Pre-assignment details
6 of the original 32 subjects who had agreed to participate in the study dropped out before any exposure to the laserlight visual cue. Therefore, data are presented only for the 26 subjects who actually participated in the study, includign exposure to this laserlight visual cue.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Who Completed Protocol This analysis includes all study participants who completed the protocol (n = 26) | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | All Study Participants Who Completed Protocol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 71 years |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
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
Population: These 13 subjects were those who were reandomized to a 1 month baseline before use of the laserlight visual cue.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 change in FOGQ score | Standard Error 0.48 |
p-value: 0.015295% CI: [0.26, 2.23]t-test, 2 sided
Secondary
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
Population: 10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Month Baseline Before Use of Laserlight Visual Cue | Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue. | without laserlight visual cue | 3.23 falls per week | Standard Deviation 1.31 |
| 1 Month Baseline Before Use of Laserlight Visual Cue | Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue. | with laserlight visual cue | 2.12 falls per week | Standard Deviation 0.92 |
Comparison: two-tailed Wilcoxan signed-rank sum testp-value: 0.02Wilcoxon (Mann-Whitney)
Secondary
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
Population: All 26 subjects who entered the study and completed the protocol, so this excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Month Baseline Before Use of Laserlight Visual Cue | Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature | Before laserlingh visual cue | 65 seconds | Standard Deviation 26.2 |
| 1 Month Baseline Before Use of Laserlight Visual Cue | Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature | With the laserlight visual cue | 57.6 seconds | Standard Deviation 23.3 |
p-value: 0.00595% CI: [23.9, 76.1]t-test, 2 sided
Secondary
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
Population: 10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Month Baseline Before Use of Laserlight Visual Cue | Percentage Change in Falls | 39.5 % change in fall frequency | Standard Deviation 9.3 |
Comparison: The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0p-value: 0.002t-test, 2 sided