NCT00322426

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 Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2006

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

June 23, 2006

Status Verified

May 1, 2006

First QC Date

May 3, 2006

Last Update Submit

June 22, 2006

Conditions

Parkinson's Disease

Keywords

Freezing of GaitParkinson's DiseaseSensory Cues

Outcome Measures

Primary Outcomes (5)

  • Total walking time

  • Number of freezes

  • Freeze time - duration of walk in which patient experiences freezing

  • Walking time - duration of walk during which patient is not experiencing freezing

  • Average duration of freeze

Interventions

Sensory Cueing DeviceDEVICE

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe comorbidity (joint problems, neuromuscular disorder affecting mobility)
  • Severe dyskinesias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kerrie Schoffer, MD

    Austin Hospital, Melbourne Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerrie Schoffer, MD

CONTACT

03-9496-2085Kerrie.SCHOFFER@austin.org.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 3, 2006

First Posted

May 5, 2006

Study Start

July 1, 2006

Study Completion

January 1, 2007

Last Updated

June 23, 2006

Record last verified: 2006-05

Locations

AU(1)