Parkinson's DiseaseNCT01727687
Investigation of Road-crossing Safety Before and After Training Between Parkinson Disease Pedestrians and Older Pedestrians
A study testing behavioral training for crossing road in people with Parkinson's Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- behavioral training for crossing road
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's disease
- Age between 18-80 years
- Patients signed the consent form
Who cannot join
- Patients with atypical parkinsonism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of Road Crossing Safety Before and After Training Between Parkinson Disease Pedestrians and Older Pedestrians
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.
- Conditions
- Parkinson's Disease
- Being tested
- behavioral training for crossing road
- Keywords
- To asses the training effects on traffic safety between normal and patients with Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral training for crossing roadBehavioural
behavioral training programs for crossing road, such as verbal oral cues and simulated traffic scenes
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's disease | Experimental | Using simulated traffic scene system to help patients with Parkinson's disease improve crossing road behaviors. Receives: Behavioral: behavioral training for crossing road |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Hsien Lin, MD. PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727687
- Sponsor's protocol ID
- PDcrossroad
- Status last verified
- Nov 2012
- First submitted
- 2 Jan 2012
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Road Crossing Safety Before and After Training Between Parkinson Disease Pedestrians and Older Pedestrians
- ClinicalTrials.gov ID
- NCT01727687
- Acronym / sponsor ID
- PDcrossroad
- Conditions
- Parkinson's Disease
- Keywords
- To asses the training effects on traffic safety between normal and patients with Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's disease | Experimental | Behavioral: behavioral training for crossing roadUsing simulated traffic scene system to help patients with Parkinson's disease improve crossing road behaviors. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Parkinson's disease
- Age between 18-80 years
- Patients signed the consent form
Key exclusion criteria (1 listed)
- Patients with atypical parkinsonism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral training for crossing roadbehavioral training programs for crossing road, such as verbal oral cues and simulated traffic scenes | Behavioural | Patients with Parkinson's disease |
Primary outcome
The parameters of cross road
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Hsien Lin, MD. PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral training for crossing road in people with Parkinson's Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The parameters of cross road (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2012.