Trial · NCT03103919
Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
NCT03103919, Phase 4, Completed, UCB Biopharma S.P.R.L.; results first posted 2019-02-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management. Trials, record NCT03103919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03103919
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
- NCT number
- NCT03103919
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 40 participants, actual
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Conditions
- Parkinson´s Disease
- Interventions
- Kinesia-ONE™, Kinesia-360™, Rotigotine
- First posted
- 2017-04-06
- Last updated
- 2019-02-19
- Results first posted
- 2019-02-19
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro) | UPDRS Part III has 27 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 27 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 108, where the maximum score indicates the worse condition. A negative value in change in Unified Parkinson's Disease Rating Scale indicates improvement, whereas a positive value indicates worsening of disease. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Primary | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) | The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. | Scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score | Rotigotine + Standard Care FAS | -1.0 | Standard Error 2.1 | Scores on a scale | |
| Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | -5.3 | Standard Error 2.0 | Scores on a scale | |
| Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score | Rotigotine + Standard Care FAS | -0.394 | Standard Error 0.160 | Scores on scale | |
| Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | -0.389 | Standard Error 0.167 | Scores on scale | |
| Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score | Rotigotine + Standard Care FAS | -0.495 | Standard Error 0.231 | Scores on a scale | |
| Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | -0.674 | Standard Error 0.238 | Scores on a scale | |
| Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores | Rotigotine + Standard Care FAS | -0.450 | Standard Error 0.156 | Scores on a scale | |
| Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | -0.525 | Standard Error 0.156 | Scores on a scale | |
| Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score | Rotigotine + Standard Care FAS | -0.489 | Standard Error 0.141 | Scores on a scale | |
| Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS | -0.342 | Standard Error 0.143 | Scores on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rotigotine + Standard Care | 20 | |
| Overall Study | STARTED | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 19 | |
| Overall Study | COMPLETED | Rotigotine + Standard Care | 18 | |
| Overall Study | COMPLETED | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 17 | |
| Overall Study | NOT COMPLETED | Rotigotine + Standard Care | 2 | |
| Overall Study | NOT COMPLETED | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 2 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vision blurred | Eye disorders | Rotigotine + Standard Care | 0 | 20 | 0 |
| other | Vision blurred | Eye disorders | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 1 | 19 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Rotigotine + Standard Care | 0 | 20 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 1 | 19 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Rotigotine + Standard Care | 1 | 20 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 0 | 19 | 0 |
| other | Constipation | Gastrointestinal disorders | Rotigotine + Standard Care | 1 | 20 | 1 |
| other | Constipation | Gastrointestinal disorders | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 0 | 19 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Rotigotine + Standard Care | 1 | 20 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 0 | 19 | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rotigotine + Standard Care | 0 | 20 |
| Total, all-cause mortality | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 0 | 19 |
| Total, other adverse events | Rotigotine + Standard Care | 9 | 20 |
| Total, other adverse events | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 10 | 19 |
| Total, serious adverse events | Rotigotine + Standard Care | 1 | 20 |
| Total, serious adverse events | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | 1 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rotigotine + Standard Care SS vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS: Number of Subjects With Any Adverse Events During the Course of the Study | Trial comparisons |
| Rotigotine + Standard Care SS vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS: Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study | Trial comparisons |
| Rotigotine + Standard Care vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device: deaths from any cause | Trial comparisons |
| Rotigotine + Standard Care vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03103919
GET https://conductscience.org/api/trials/v1/NCT03103919/results?page=2