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Trial registered on ANZCTR


Registration number
ACTRN12613000286741
Ethics application status
Approved
Date submitted
22/02/2013
Date registered
12/03/2013
Date last updated
28/06/2021
Date data sharing statement initially provided
28/06/2021
Date results provided
28/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of biofeedback training to improve gait function in people with stroke
Scientific title
Feasibility of biofeedback training to improve gait function in people with stroke
Secondary ID [1] 282009 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 288451 0
Condition category
Condition code
Stroke 288793 288793 0 0
Ischaemic
Stroke 288922 288922 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Foot clearance data will be displayed in real-time on a screen and the particpants will be required to maintain their foot position within the target clearance band while walking on the treadmill at their preferred walking speed. The retraining program includes eight sessions spread over a 3-4 week period; each training session will include 5-10 minutes of treadmill walking. The intervention will be administered by a physiotherapist.
Intervention code [1] 286581 0
Rehabilitation
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288933 0
Minimum Foot clearance. This will be measured using an Optotrak motion analysis system.
Timepoint [1] 288933 0
Baseline (week 1), post-intervention (weeks 9 and 10)
Secondary outcome [1] 301384 0
Gait speed.

This will be measured using treadmill.
Timepoint [1] 301384 0
Baseline (week 1), post-intervention (weeks 9 and 10)
Secondary outcome [2] 301608 0
stance/swing times.
This will be measured using an Optotrak motion analysis system.
Timepoint [2] 301608 0
Baseline (week 1), post-intervention (weeks 9 and 10)
Secondary outcome [3] 301609 0
Joint angles.

This will be measured using an Optotrak motion analysis system.
Timepoint [3] 301609 0
Baseline (week 1), post-intervention (weeks 9 and 10)
Secondary outcome [4] 301610 0
Centre of pressure.

This will be measured using F-scan foot pressure system.
Timepoint [4] 301610 0
Baseline (week 1), post-intervention (weeks 9 and 10)

Eligibility
Key inclusion criteria
Participants will be adults over 18 years who have suffered a stroke at least 6 months previously. Participants must be able to walk independently 50 m (with or without a stick) and be able to give informed consent. They must not be receiving any physiotherapy during the 8 weeks of the study. They must also be able to understand and follow instructions in English.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they require an ankle foot orthosis, as this may limit their ability to modify toe clearance. Participants will be excluded if they have any other neurological, orthopaedic, cardiac, respiratory or other medical conditions that may impact on their walking or their ability to walk on a treadmill. Participants who are pregnant will be excluded. Participants with visual problems or visual-spatial neglect will also be excluded. Stoke patients who may be “stabilising” will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be required to sign a consent form.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Safety
Statistical methods / analysis
Repeated measures ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/03/2013
Actual
8/03/2013
Date of last participant enrolment
Anticipated
Actual
19/02/2015
Date of last data collection
Anticipated
Actual
19/02/2015
Sample size
Target
10
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286784 0
University
Name [1] 286784 0
Victoria University
Country [1] 286784 0
Australia
Primary sponsor type
Individual
Name
Dr Cathy Said
Address
Physiotherapy Site Manager,
Heidelberg Repatriation Hospital,
PO Box 5444, Heidelberg West
VIC 3084
Country
Australia
Secondary sponsor category [1] 285567 0
None
Name [1] 285567 0
Address [1] 285567 0
Country [1] 285567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288851 0
Austin Health Ethics Committee
Ethics committee address [1] 288851 0
145 Studley Road, PO Box 5555, Heidelberg, vic 3084
Ethics committee country [1] 288851 0
Australia
Date submitted for ethics approval [1] 288851 0
Approval date [1] 288851 0
11/12/2012
Ethics approval number [1] 288851 0
H2012/04856

Summary
Brief summary
The aim of this project is to demonstrate the feasibility of using visual feedback to increase minimum toe clearance during walking in people with stroke. This intervention has the potential to improve walking safety and reduce falls. Ten participants will be required to attend 10 sessions. The training sessions will occur over a 3-4 week period, with at least one rest day between sessions. At all sessions, participants will be required to walk on a treadmill for 5-10 minutes. They will wear exercise shorts and also a safety harness which will prevent them from falling. Participants will also have markers placed on their lower limbs, and a special camera (Optotrak) will record the movement of these markers while participants walk. They will also wear insoles in their shoes (FScan), which will record pressure under their feet. Data will be recorded during assessment sessions, and additional clinical data will also be obtained. Participants will be asked some questions about their risk of falls. During the training sessions, participants will be asked to modify their walking pattern to match a “target” minimum toe clearance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38066 0
Prof Rezaul Begg
Address 38066 0
Biomechanics Unit, ISEAL, Victoria University,
PO BOx 14428, Melbourne,
Vic 8001
Country 38066 0
Australia
Phone 38066 0
+61 3 9919 1116
Fax 38066 0
Email 38066 0
rezaul.begg@vu.edu.au
Contact person for public queries
Name 38067 0
Cathrine Said
Address 38067 0
Physiotherapy Department
Heidelberg Repatriation Hospital
PO Box 5444
Heidelberg West
VIC 3084
Country 38067 0
Australia
Phone 38067 0
+61 3 9496 2055
Fax 38067 0
Email 38067 0
cathy.said@austin.org.au
Contact person for scientific queries
Name 38068 0
Rezaul Begg
Address 38068 0
Biomechanics Unit, ISEAL, Victoria University,
PO BOx 14428, Melbourne,
Vic 8001
Country 38068 0
Australia
Phone 38068 0
+61 3 9919 1116
Fax 38068 0
Email 38068 0
rezaul.begg@vu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Begg, R, Tirosh, O, Said, C, Sparrow, W & Steinber... [More Details]
Conference abstractNo Said C, Tirosh O, Galea, M P and Begg RK. Toe clea... [More Details]
Study results articleYes Nagano, H, Said, C.M, James, L " Begg, R.K. 2020, ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility of using foot-ground clearance biofeedback training in treadmill walking for post-stroke gait rehabilitation.2020https://dx.doi.org/10.3390/brainsci10120978
N.B. These documents automatically identified may not have been verified by the study sponsor.