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Kinesia HomeView - Home Diary Comparison

Kinesia HomeView - Home Diary Comparison

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01920425
Enrollment
2
Registered
2013-08-12
Start date
2013-07-31
Completion date
2015-09-30
Last updated
2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, dyskinesia, fluctuations, tremor, bradykinesia, levodopa

Brief summary

The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView to electronic and hand-written diaries for tracking medication state in the home. Demonstrating comparable or superior results will further support use of the Kinesia HomeView system as an outcome measure in clinical drug trials.

Interventions

Motion sensor based telemedicine system for assessment of movement disorder motor symptoms in the home. Includes automated motor assessment using motion sensor and electronic dyskinesia diary.

OTHERHand-written diary

Hand-written paper diary indicating state (Off, On without dyskinesias, on with non-troublesome dyskinesias, on with troublesome dyskinesias) at 30 minute intervals.

Sponsors

Great Lakes NeuroTechnologies Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of Parkinson's disease * On a stable antiparkinsonian medication regimen that includes levodopa for at least 4 weeks * Experiencing dyskinesia more than 25% of the waking day (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 32) * With dyskinesias at least moderately disabling (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 33) * Capable of accurately completing diaries * Capable of accurately using Kinesia HomeView

Exclusion criteria

* Significant medical or psychiatric illness * Subjects not capable of following the required clinical instructions * Serious medical conditions that would compromise safety

Design outcomes

Primary

MeasureTime frameDescription
Test-retest reliability4 weeksTest-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.

Secondary

MeasureTime frameDescription
Kinesia HomeView usability questionnaireAfter 4 weeksQuestionnaires on the usability of Kinesia HomeView will be completed following the 4-week data collection period.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026