Trial Outcomes & Findings for BradyXplore Phase II: Bradykinesia Feature Extraction System (NCT NCT02358876)
NCT ID: NCT02358876
Last Updated: 2016-10-06
Results Overview
Percentage of Kinesia One assessments performed as directed
Recruitment status
COMPLETED
Target enrollment
32 participants
Primary outcome timeframe
Two weeks
Results posted on
2016-10-06
Participant Flow
Participant milestones
| Measure |
Participants
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BradyXplore Phase II: Bradykinesia Feature Extraction System
Baseline characteristics by cohort
| Measure |
Participants
n=32 Participants
|
|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two weeksPercentage of Kinesia One assessments performed as directed
Outcome measures
| Measure |
Participants
n=30 Participants
|
|---|---|
|
Percentage of Kinesia One Assessments Performed
|
99 percentage of home assessments completed
Standard Deviation 2
|
Adverse Events
Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Biomedical Research Manager
Great Lakes NeuroTechnologies Inc
Phone: 2163615410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60