N/A
Completed N=32
Laser Light Cues for Gait Freezing in Parkinson's Disease
Source: ClinicalTrials.gov NCT00320242 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: 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 — p=0.0152
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
1.25 | 0.0152 sig |
| SECONDARY Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature |
65; 57.6 | 0.005 sig |
| SECONDARY Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue. |
3.23; 2.12 | 0.02 sig |
| SECONDARY Percentage Change in Falls |
39.5 | 0.002 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00320242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.