Phase 4
Completed N=39
Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Source: ClinicalTrials.gov NCT03103919 ↗Enrolled (actual)
39
Serious AEs
5.1%
Results posted
Feb 2019
Primary outcomePrimary: Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score — -1.0; -5.3 Scores on a scale — p==0.134
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence to Neupro compared with only standard clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score |
-1.0; -5.3 | =0.134 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score |
-0.394; -0.389 | =0.982 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score |
-0.495; -0.674 | =0.566 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores |
-0.450; -0.525 | =0.720 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score |
-0.489; -0.342 | =0.443 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score |
0.083; -0.009 | =0.777 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score |
-0.178; -0.188 | =0.947 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score |
0.119; -0.147 | =0.306 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score |
-0.202; -0.171 | =0.819 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score |
-0.240; -0.167 | =0.663 |
| PRIMARY Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score |
0.125; -0.074 | =0.197 |
| PRIMARY Neupro Dose Per 24h at Visit 2 (Week 12) |
3.9; 4.8 | — |
| PRIMARY Number of Neupro Dose Changes During the Study |
1.8; 2.8 | — |
| PRIMARY Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study |
5; 5 | =0.876 |
| SECONDARY Number of Subjects With Any Adverse Events During the Course of the Study |
9; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is newly prescribed Neupro and is expected to commence Neupro treatment. Historical Neupro treatment is permitted
- Informed Consent form (ICF) is signed and dated by the subject, before any study-related procedures
- Subject is considered reliable and capable of adhering to the protocol, visit schedule, completion of the diary, and using Kinesia devices according to the judgment of the Investigator
- Male or female subject, >=18 years of age at the time of the Screening Visit
- Subject has Parkinson's disease, defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: tremor at rest, rigidity or impairment of postural reflexes, and without any other known or suspected cause of Secondary Parkinsonism
- Subject experiences motor symptoms associated with Parkinson's disease that are not sufficiently controlled by current therapy. The average of the triplicate resting tremor scores and triplicate finger tapping scores from Kinesia-ONE™ (6 scores in total) must be >1.0
Exclusion Criteria
- Subject is currently participating in any study with an investigational medicinal product or investigational device
- Subject has any medical, neurological or psychiatric condition which, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
- Subject with Deep Brain Stimulation (DBS) device implant
Data sourced from ClinicalTrials.gov (NCT03103919). 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.