NCT01356056

Brief Summary

The purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. The main goal of this research is to develop a quantitative system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a home based system which can capture those symptom changes over the course of a day and aid in evaluating treatment protocol efficacy.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

May 17, 2011

Last Update Submit

March 11, 2013

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

  • UPDRS

    Every 4 weeks

  • PDQ-39

    Every 4 weeks

Study Arms (2)

Kinesia HomeView Monitoring

Uses Kinesia HomeView at home once per week

Device: Kinesia HomeView

Control

Assessed in the clinic every 4 weeks using traditional methods

Interventions

Kinesia HomeViewDEVICE

Quantifies motor symptom severity in the home

Kinesia HomeView Monitoring

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease

You may qualify if:

  • Clinical diagnosis of Parkinson's disease

You may not qualify if:

  • Inability to follow the required clinical instruction
  • Subjects with cognitive impairments that would prohibit them from properly using the Kinesia HomeView system
  • Subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable
  • Subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 19, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

US(1)