Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000605291
Ethics application status
Approved
Date submitted
16/07/2009
Date registered
21/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
External cues (audiovisual) for the regulation of gait in Parkinson's disease
Scientific title
External cues (audiovisual) for the regulation of gait in Parkinson's disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 237269 0
Condition category
Condition code
Neurological 239591 239591 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study used a reversal design (A-B-A). Participantis are assessed for 5 weeks prior to the intervention to establish a baseline level of behaviour (A). The intervention program is then administered for 5 weeks (B). On completion of the program, the same parameters are assessed for 5 weeks without intervention (A).
During the intervention the participant walked while he was submitted to visual (laser pointer fixed in the subject thorax projecting a mark in the ground) and auditory (metronome) stimulations simultaneously.
Duration fo sessions: 30 minutes.
Frequency of sessions: three times per week.
Mode of administration of the intervention: sessions administered/supervised by physical educator.
Intervention code [1] 236949 0
Rehabilitation
Comparator / control treatment
No treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238381 0
Effects of a gait training program on gait motor variables (cadence, speed, stride length and stride time) assessed with video analysis and reflective markers.
Timepoint [1] 238381 0
3 times per week during 15 weeks.
Secondary outcome [1] 244832 0
Nil
Timepoint [1] 244832 0
Nil

Eligibility
Key inclusion criteria
Parkinson's disease patient, able to walk 5 minutes continually.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hearing deficiency, visual deficiency.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation is not concealed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 1885 0
Brazil
State/province [1] 1885 0
Santa Catarina (SC)

Funding & Sponsors
Funding source category [1] 237339 0
University
Name [1] 237339 0
Universidade Federal de Santa Catarina
Country [1] 237339 0
Brazil
Primary sponsor type
Individual
Name
Diogo Cunha dos Reis
Address
Rua Barão Von Wangenhein, 198
Jardim Atlântico
Florianópolis - SC - Brazil
Country
Brazil
Secondary sponsor category [1] 236826 0
None
Name [1] 236826 0
Address [1] 236826 0
Country [1] 236826 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239457 0
Comite de Etica em Pesquisa com Seres Humanos - UFSC
Ethics committee address [1] 239457 0
Ethics committee country [1] 239457 0
Brazil
Date submitted for ethics approval [1] 239457 0
20/04/2008
Approval date [1] 239457 0
30/05/2008
Ethics approval number [1] 239457 0
03508

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

Contacts
Principal investigator
Name 29908 0
Address 29908 0
Country 29908 0
Phone 29908 0
Fax 29908 0
Email 29908 0
Contact person for public queries
Name 13155 0
Diogo Cunha dos Reis
Address 13155 0
Rua Barão Von Wangenhein, 198
Jardim Atlântico
Florianópolis - SC - Brazil
Country 13155 0
Brazil
Phone 13155 0
55 48 3721 8530
Fax 13155 0
55 48 3721 9927
Email 13155 0
moro@cds.ufsc.br
Contact person for scientific queries
Name 4083 0
Diogo Cunha dos Reis
Address 4083 0
Rua Barão Von Wangenhein, 198
Jardim Atlântico
Florianópolis - SC - Brazil
Country 4083 0
Brazil
Phone 4083 0
55 48 3721 8530
Fax 4083 0
55 48 3721 9927
Email 4083 0
moro@cds.ufsc.br

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.