NCT01727687

Brief Summary

As society ages, a large amount of human factors related research has been carried out into the subject of the safety of the elderly in their daily lives. However, most research focuses on the general elderly population and there is a serious lack of research into elderly sufferers of Parkinson's disease (PD), who receive a substantial amount of attention in medical circles. In the investigators previous study, the investigators have found that patient with PD had decreased ability to cross the road as compared to age/gender matched control subjects. Hence, this research proposed several training programs to enhance the safety of crossing road, including safe place finding,roadside search,time gap and perception of other's intentions. The investigators will compare the parameters of crossing road ability before and after training programs in patients with PD and control subjects. The results of this research will clarify the correlation between medical scale test indicators and movement safety for patients with PD. The effects of training programs will be provided for further safety management and design concepts to improve the lives of this disease group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

January 2, 2012

Last Update Submit

November 12, 2012

Conditions

Keywords

To asses the training effects on traffic safety between normal and patients with Parkinson's disease

Outcome Measures

Primary Outcomes (1)

  • The parameters of cross road

    The main outcome variables were crossing time (CT), remaining time (RT), and safety margin (SM). The CT was the time taken by the subjects to cross the 3.5-m-wide road. The CT was measured at the normal walking pace and the fastest pace of each individual. Response time was measured in the simulated traffic situation and was defined as the time between starting the visual situation and the participant pressing the response button to decide to cross the road. The RT was the difference between the time gap (between the coming vehicle and the pedestrian) and the response time.

    1 year

Study Arms (1)

Patients with Parkinson's disease

EXPERIMENTAL

Using simulated traffic scene system to help patients with Parkinson's disease improve crossing road behaviors.

Behavioral: behavioral training for crossing road

Interventions

behavioral training programs for crossing road, such as verbal oral cues and simulated traffic scenes

Patients with Parkinson's disease

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Parkinson's disease
  • Age between 18-80 years
  • Patients signed the consent form

You may not qualify if:

  • Patients with atypical parkinsonism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Chin-Hsien Lin, MD. PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2012

First Posted

November 16, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 16, 2012

Record last verified: 2012-11

Locations