Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000250336
Ethics application status
Approved
Date submitted
13/02/2017
Date registered
17/02/2017
Date last updated
1/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Biofeedback gait training in stroke patients.
Scientific title
Can Real-time Biofeedback of Foot Clearance Data be used to Assist with Gait Rehabilitation following Stroke?
Secondary ID [1] 290295 0
None
Universal Trial Number (UTN)
U1111-1190-9798
Trial acronym
Linked study record
Begg RK, Tirosh O, Said CM, Sparrow W, Steinberg N, Levinger P and Galea MP (2014). "Gait training with real-time augmented toe-ground clearance information decreases tripping risk in older adults and a person with chronic stroke". Frontiers in Human Neuroscience, 8:243. doi: 10.3389/fnhum.2014.00243

Health condition
Health condition(s) or problem(s) studied:
Stroke 300535 0
Tripping risk 300536 0
Falls 300537 0
Condition category
Condition code
Stroke 300396 300396 0 0
Haemorrhagic
Stroke 300397 300397 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants who have given informed consent will be randomly assigned to one of two gait training groups: no-feedback (control), and feedback (experimental group).

Clinical and Demographic Assessment (all participants): Demographic and anthropometric data will be collected at initial assessment; including age, gender, body mass, standing height, lesion site, date of stroke and medical history. Clinical tests will be conducted at initial assessment and the 4 post training retention tests to provide information about specific impairments, and level of function. Clinical tests will be conducted by an experienced physiotherapist who is blind to group allocation:

Baseline gait assessment (all participants) - Conducted at Victoria University biomechanics laboratory and at Austin Repatriation Hospital within the physiotherapy department.

Gait assessments will include both treadmill walking and overground walking to establish pre-training (Baseline) performance and determine the Minimum Toe Clearance (MTC) feedback criterion for the experimental group. Training and testing will be undertaken in comfortable walking shoes. Participants will wear the same shoes throughout. Participants will also wear a safety harness and will walk at their preferred walking speed (calculated during treadmill familiarisation during visit 1 (session 1).

Markers will be placed on the shoe, lower limb and the trunk. Optotrak 3D motion capture system will be used to determine the trajectory of the markers and Visual 3D software will be used to determine Minimum Toe Clearance event for each walking stride and calculate the vertical displacement between the ground (treadmill belt) and the forefoot at this event (MTC). The mean and standard deviation of MTC will be calculated.

Once baseline assessment has been completed, all participants will complete 10 gait training sessions of treadmill walking over 5-6 weeks, with MTC target information presented in real-time for the experimental group.

Participants will walk for up to 10 minutes during gait training. A single marker will be placed on the forefoot area of the affected limb to calculate toe clearance in real-time. Participants will be asked to modify their gait pattern to match a required “target” criterion (increased MTC). Baseline MTC data from the affected limb will be used to set the training target at mean baseline MTC plus one standard deviation. The training target MTC will be projected on a screen in front of the participant with parallel lines above and below indicating a target band. Participants will view their toe movement and minimum clearance in real-time and will be required to modify their affected limb motion to match the “target” toe clearance. Borg rating of perceived exertion will be recorded after each session.
.
The first 6 sessions will involve continuous visual biofeedback. Duration of biofeedback will then be progressively reduced (faded) across the remaining four sessions.

Gait assessment will again be conducted after the final training session, one at 1-month post training and two relatively longer-term (3 months and 6 months). In retention conditions, participants will be asked to reproduce the movement criterion presented during the gait training sessions but no feedback will be provided.

Intervention code [1] 296609 0
Rehabilitation
Intervention code [2] 296678 0
Treatment: Devices
Comparator / control treatment
The control group will undertake all gait training sessions similar to the experimental group but with no feedback of MTC signal. A single marker will be placed on the forefoot (toe area) in order to calculate MTC as for the experimental group.
Control group
Active

Outcomes
Primary outcome [1] 300463 0
Minimum Toe Clearance (MTC) height using Optotrak 3D motion capture system and Inertial Measurement Units (IMUs).
Timepoint [1] 300463 0
Baseline, at conclusion of training sessions, and at one, three, and six months post-training.
Secondary outcome [1] 330025 0
Falls Risk for Older People in the Community (FROP-Com)
Timepoint [1] 330025 0
Baseline, at conclusion of training sessions, and at one, three, and six months post-training.
Secondary outcome [2] 330205 0
Gait function measures using Optotrak 3D motion capture system.
Timepoint [2] 330205 0
Baseline, at conclusion of training sessions, and at one, three, and six months post-training.
Secondary outcome [3] 330206 0
Number of falls using Falls Calendar
Timepoint [3] 330206 0
Monthly Follow-up after enrolment (up to 12 Months)
Secondary outcome [4] 330256 0
Functional Independence Measure (FIM)
Timepoint [4] 330256 0
Baseline, at conclusion of training sessions, and at one, three, and six months post-training.

Eligibility
Key inclusion criteria
Participants will be adults over 18 years who have sustained a stroke at least 6 months previously, are able to walk 50 metres independently and cognitively capable of providing informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Require an ankle foot orthosis, electrical stimulation or other assistance to dorsiflexion.
2. Are pregnant.
3. Have (in addition to stroke) additional neurological, orthopaedic, cardiac, respiratory or other medical conditions that may impact on their ability to walk on a treadmill.
4. Have multiple strokes. Participants will still be eligible if incidental lesions are identified on imaging, so long as there is no clinical history of previous stroke.
5. Are over 158 kg (weight limit of the harness system).
6. Have visual problems or visual-spatial neglect, as the protocol relies on visual biofeedback. People who score < 22 on the star cancellation test will be excluded.

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)
Central randomisation by computer (concealed allocation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Sample size calculations:
To detect differences in MTC, a medium effect size between the group effects (No-Feedback vs Feedback) across the two time points (Baseline and post-training) we need a total sample of 126 or 63 per group (a=0.05, power =0.85). To allow for a 20% drop out, we shall recruit 75 participants per group or a total of 150 participants at the start.

Statistical methods:
1) Between-group comparisons of MTC post-training will reveal effectiveness of the biofeedback gait training method in improving MTC.
2) The within-subject analysis of the Feedback group will reveal the biofeedback effects on MTC by comparing each participant’s after intervention (post-training) data to that obtained in retention conditions.
3) MTC data collected during overground walking during retention conditions will determine whether any changes in MTC are translated to overground walking.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2017
Actual
18/05/2017
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
150
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7090 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [2] 7091 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 7092 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [4] 7093 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 7161 0
Royal Talbot Rehabilitation Centre - Kew
Recruitment postcode(s) [1] 14820 0
3052 - Parkville
Recruitment postcode(s) [2] 14821 0
3081 - Heidelberg West
Recruitment postcode(s) [3] 14822 0
3084 - Heidelberg
Recruitment postcode(s) [4] 14919 0
3101 - Kew

Funding & Sponsors
Funding source category [1] 295145 0
Government body
Name [1] 295145 0
National Health and Medical Research Council (NHMRC)
Country [1] 295145 0
Australia
Primary sponsor type
University
Name
Victoria Unversity
Address
Institute of Sport, Exercise and Active Living (ISEAL),
Victoria University, Footscray Park Campus
PO Box 14428
Melbourne Vic 8001
Country
Australia
Secondary sponsor category [1] 293971 0
None
Name [1] 293971 0
Address [1] 293971 0
Country [1] 293971 0
Other collaborator category [1] 279363 0
Hospital
Name [1] 279363 0
Austin Health
Address [1] 279363 0
145 Studley Road
Heidelberg Vic 3084
Country [1] 279363 0
Australia
Other collaborator category [2] 279364 0
Hospital
Name [2] 279364 0
Melbourne Health
Address [2] 279364 0
Level 8 South
The Royal Melbourne Hospital
300 Grattan Street
Melbourne Vic 3050
Country [2] 279364 0
Australia
Other collaborator category [3] 279365 0
University
Name [3] 279365 0
The University of Melbourne
Address [3] 279365 0
Grattan Street
Parkville Vic 3010
Country [3] 279365 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296491 0
Austin Health
Ethics committee address [1] 296491 0
P.O. Box 5555
Heidelberg Vic 3084
Ethics committee country [1] 296491 0
Australia
Date submitted for ethics approval [1] 296491 0
Approval date [1] 296491 0
23/06/2016
Ethics approval number [1] 296491 0
ND 15/516

Summary
Brief summary
The aim of this project is to demonstrate the effectiveness of using visual feedback to increase toe clearance during walking in people with stroke. This new intervention has the potential to improve walking safety and reduce the risk of trips and falls. One important gait variable in these types of trips is minimum toe clearance (MTC). Reduced MTC can increase the risk of tripping.

150 participants will be required to attend 16 sessions (two baseline assessments (one clinical assessment conducted by a Physiotherapist and practice walking on the treadmill, the other is biomechanical assessment to determine MTC), 10 gait training only, and 4 post-training assessments (one after completing the final training, and then 1 month, 3 months and 6 months post-training follow up session). Half of the participants (n=75) will be randomly assigned to an Experimental group who will receive treadmill-based gait training with toe clearance feedback and half will comprise a Control group who will undertake assessment and training trials exactly as the Experimental group but will NOT receive the corrective real time feedback. The ten training sessions will occur over a 5-6 week period, with at least one rest day between sessions. Six assessment sessions will be about 90 minutes duration. The training sessions will take approximately 60 minutes.

At all sessions, participants will be required to walk on a treadmill for up to 10 minutes. They will wear 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. 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, data from markers will provide ‘real time’ feedback to Experimental participants about their affected leg toe clearance during the swing phase of walking. Using this information, participants will be asked to modify their walking pattern to match a “target” increased toe clearance. Feedback will be provided continuously for the first 6 sessions and then progressively reduced (faded) across the last 4 sessions.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1312 1312 0 0
/AnzctrAttachments/371623-20160623 LETTER HREC15Austin516 Jul16 (Ethics approval new study).pdf (Ethics approval)
Attachments [2] 1313 1313 0 0
/AnzctrAttachments/371623-20161013 LETTER HREC15Austin516 Nov16 ( Ethics approval amendment - protocol).pdf (Ethics approval)

Contacts
Principal investigator
Name 69550 0
Prof Rezaul Begg
Address 69550 0
Institute of Sport, Exercise and Active Living (ISEAL)
Victoria University, Footscray Park Campus
PO Box 14428
Melbourne Vic 8001
Country 69550 0
Australia
Phone 69550 0
+61 3 9919 1116
Fax 69550 0
Email 69550 0
[email protected]
Contact person for public queries
Name 69551 0
Prof Rezaul Begg
Address 69551 0
Institute of Sport, Exercise and Active Living (ISEAL)
Victoria University, Footscray Park Campus
PO 14428
Melbourne Vic 8001
Country 69551 0
Australia
Phone 69551 0
+61 3 9919 1116
Fax 69551 0
Email 69551 0
[email protected]
Contact person for scientific queries
Name 69552 0
Prof Rezaul Begg
Address 69552 0
Institute of Sport, Exercise and Active Living (ISEAL)
Victoria University, Footscray Park Campus
PO 14428
Melbourne Vic 8001
Country 69552 0
Australia
Phone 69552 0
+61 3 9919 1116
Fax 69552 0
Email 69552 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23461Study protocolBegg, R., Galea, M.P., James, L. et al. Real-time foot clearance biofeedback to assist gait rehabilitation following stroke: a randomized controlled trial protocol. Trials 20, 317 (2019). https://doi.org/10.1186/s13063-019-3404-6https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3404-6 

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReal-time foot clearance biofeedback to assist gait rehabilitation following stroke: A randomized controlled trial protocol.2019https://dx.doi.org/10.1186/s13063-019-3404-6
N.B. These documents automatically identified may not have been verified by the study sponsor.