Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001093774
Ethics application status
Approved
Date submitted
16/09/2013
Date registered
30/09/2013
Date last updated
18/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-invasive brain stimulation for the treatment of gait disturbances in Parkinson’s disease: a pilot randomised, double-blind, sham-controlled trial.
Scientific title
An investigation of dual task training with non-invasive brain stimulation versus dual task training with sham brain stimulation in people with Parkinson’s Disease to evaluate the effects on gait when dual tasking.
Secondary ID [1] 283219 0
No secondary ID
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 290091 0
Condition category
Condition code
Neurological 290467 290467 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nine one-hour sessions of walking training to improve step length whilst concurrently performing added cognitive or motor tasks will be undertaken in an outpatient rehabilitation setting with a physiotherapist over 3 weeks (3 sessions per week). Walking training will be one-on-one, progressed and include tasks such as walking, turning, and obstacle negotiation whilst concurrently performing added tasks such as conversation, mathematics, and route-finding. A home program of exercises and strategies will be provided. These will be customized to the individual. Examples include a walking program adding dual tasking (e.g. a 20 minute walk on a bike path with a carer, conversing for 5 minutes on and 5 minutes off) and postural exercises such as standing with back to a wall and holding an erect posture for 20 second holds. A diary will be used to record adherence to the home exercise protocol. Training will be combined with anodal transcranial direct current stimulation applied to the left primary motor cortex at 2mA for 20 minutes at the beginning of each training session.
Intervention code [1] 287947 0
Rehabilitation
Intervention code [2] 287948 0
Treatment: Devices
Comparator / control treatment
Nine, one-hour sessions of walking training to improve step length whilst concurrently performing added cognitive or motor tasks will be undertaken in an outpatient rehabilitation setting with a physiotherapist over 3 weeks (3 sessions per week). Walking training will be one-on-one, progressed and include tasks such as walking, turning, and obstacle negotiation whilst concurrently performing added tasks such as conversation, mathematics, and route-finding. A home program of exercises and strategies will be provided. These will be customized to the individual. Examples include a walking program adding dual tasking (e.g. a 20 minute walk on a bike path with a carer, conversing for 5 minutes on and 5 minutes off) and postural exercises such as standing with back to a wall and holding an erect posture for 20 second holds. A diary will be used to record adherence to the home exercise protocol. Training will be combined with sham transcranial direct current stimulation applied to the left primary motor cortex for 20 minutes at the beginning of each training session. For sham stimulation, the current will be ramped up over 10 seconds and then ramped down over a further 10 seconds before being switched off. This is a standard sham approach in tDCS studies which ensures that participants feel the initial tingling sensation associated with tDCS. The tDCS unit will be placed out of sight for both the active and sham interventions.
Control group
Active

Outcomes
Primary outcome [1] 290492 0
Comfortable gait speed when dual tasking over 8 meters measured using a GAITrite electronic walkway.
Timepoint [1] 290492 0
Baseline, in the week following conclusion of the 9th training session, follow-up 3 months post intervention
Secondary outcome [1] 304624 0
Spatiotemporal gait parameters (step length, cadence) during single and dual task conditions over 8 meters measured using a GAITrite electronic walkway.
Timepoint [1] 304624 0
Baseline, in the week following conclusion of the 9th training session, follow-up 3 months post intervention
Secondary outcome [2] 304625 0
Visuo-motor speed and procedural learning using a serial reaction time task.
Timepoint [2] 304625 0
Baseline, in the week following conclusion of the 9th training session, follow-up 3 months post intervention.
Secondary outcome [3] 304626 0
Attention using Trail-making A and B tests
Timepoint [3] 304626 0
Baseline, in the week following conclusion of the 9th training session, follow-up 3 months post intervention.
Secondary outcome [4] 304627 0
Bradykinesia will be assessed as the time to perform the following sequence 10 times: (1) hand closing (squeezing a ball) and opening; (2) elbow flexion; (3) hand closing and opening; and (4) elbow extension and using the Unified Parkinson’s Disease Rating Scale UPDRS.
Timepoint [4] 304627 0
Baseline, in the week following conclusion of the 9th training session, follow-up 3 months post intervention.

Eligibility
Key inclusion criteria
All participants will be aged over 18 years and have a diagnosis of idiopathic PD using the UK Brain Bank criteria. Additional inclusion criteria will comprise: being able to walk 100m independently with or without gait aids; rated stage I-IV on the Hoehn and Yahr disability scale (Hoehn and Yahr 1967); and report reduced step length or slowed gait speed, confirmed by clinical examination.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have metal objects or stimulators in the head that might pose a hazard during tDCS; neurological conditions other than PD; musculoskeletal or cardiopulmonary conditions that affect the ability to safely walk; score < 24 on the Mini-Mental Status Examination (MMSE; Folstein et al 1975) or sensory system pathology affecting walking or communication (e.g. blindness, deafness).

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)
Off-site concealed randomisation will be prepared by a researcher using a computer generated random number sequence. Consecutively numbered, randomly ordered opaque envelopes containing group allocation will be opened consecutively by the therapist implementing the two types of intervention. The person recruiting thus will not know to which group the subject will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number will be used to generate the sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Eight participants per group were chosen for this pilot trial as previous studies have reported a 5 - 20% change in gait speed after 8 sessions of tDCS alone with similar participant numbers in each group (Benninger et al 2011). An improvement of approximately 20% in gait speed with the physiotherapy dual task training alone has also been shown (Brauer and Morris 2010).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2013
Actual
Date of last participant enrolment
Anticipated
31/01/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287968 0
Charities/Societies/Foundations
Name [1] 287968 0
Parkinson's QLD Inc
Country [1] 287968 0
Australia
Primary sponsor type
Individual
Name
Dr Siobhan Schabrun
Address
University of Western Sydney| Campbelltown Campus, Locked Bag 1797, Penrith NSW 2751, Australia
Country
Australia
Secondary sponsor category [1] 286686 0
Individual
Name [1] 286686 0
Professor Sandra Brauer
Address [1] 286686 0
Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
Country [1] 286686 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289891 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 289891 0
Ethics committee country [1] 289891 0
Australia
Date submitted for ethics approval [1] 289891 0
Approval date [1] 289891 0
06/06/2012
Ethics approval number [1] 289891 0
2012000508

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

Contacts
Principal investigator
Name 42966 0
Dr Siobhan Schabrun
Address 42966 0
University of Western Sydney, Campbelltown Campus, Locked Bag 1797, Penrith NSW 2751, Australia
Country 42966 0
Australia
Phone 42966 0
+61 2 4620 3497
Fax 42966 0
+61 2 4620 3792
Email 42966 0
[email protected]
Contact person for public queries
Name 42967 0
Sandra Brauer
Address 42967 0
Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
Country 42967 0
Australia
Phone 42967 0
+61 7 3365 2317
Fax 42967 0
+61 7 3365 1622
Email 42967 0
[email protected]
Contact person for scientific queries
Name 42968 0
Sandra Brauer
Address 42968 0
Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
Country 42968 0
Australia
Phone 42968 0
+61 7 3365 2317
Fax 42968 0
+61 7 3365 1622
Email 42968 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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