Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00322426




Registration number
NCT00322426
Ethics application status
Date submitted
3/05/2006
Date registered
5/05/2006
Date last updated
23/06/2006

Titles & IDs
Public title
Sensory Cues for Freezing in Parkinson's Disease
Scientific title
Effect of Randomized Patient-Triggered Sensory Cues for Freezing of Gait in Parkinson's Disease
Secondary ID [1] 0 0
1-Schoffer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total walking time
Timepoint [1] 0 0
Primary outcome [2] 0 0
Number of freezes
Timepoint [2] 0 0
Primary outcome [3] 0 0
Freeze time - duration of walk in which patient experiences freezing
Timepoint [3] 0 0
Primary outcome [4] 0 0
Walking time - duration of walk during which patient is not experiencing freezing
Timepoint [4] 0 0
Primary outcome [5] 0 0
Average duration of freeze
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
* Currently living in Melbourne, Australia (note that we cannot respond to enquiries from outside of this area)
* Confirmed diagnosis of Parkinson's disease
* Stabilized drug therapy for at least 1 month prior to the study and during
* Hearing and vision - Able to identify lines on floor, hear metronome
* MMSE >24
* Able to walk independently (with or without a mechanical aid)
* Able to give informed consent
Minimum age
40 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Severe comorbidity (joint problems, neuromuscular disorder affecting mobility)
* Severe dyskinesias

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kerrie Schoffer, MD
Address 0 0
Austin Hospital, Melbourne Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kerrie Schoffer, MD
Address 0 0
Country 0 0
Phone 0 0
03-9496-2085
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00322426