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/ct2/show/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
Treatment: Devices - Sensory Cueing Device

Treatment: Devices: Sensory Cueing Device
Intervention code [1] 0 0
Treatment: Devices
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
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
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is (1) to determine if patient triggered sensory(auditory, visual
and tactile) cues can help treat freezing of gait in Parkinson's disease, and (2) to assess
if unexpected (randomized) cues are more effective than anticipated ones.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00322426
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
Kerrie.SCHOFFER@austin.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00322426