ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Tripping risk

Falls

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

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]

Rehabilitation

Intervention code [2]

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]

Minimum Toe Clearance (MTC) height using Optotrak 3D motion capture system and Inertial Measurement Units (IMUs).

Timepoint [1]

Baseline, at conclusion of training sessions, and at one, three, and six months post-training.

Secondary outcome [1]

Falls Risk for Older People in the Community (FROP-Com)

Timepoint [1]

Baseline, at conclusion of training sessions, and at one, three, and six months post-training.

Secondary outcome [2]

Gait function measures using Optotrak 3D motion capture system.

Timepoint [2]

Baseline, at conclusion of training sessions, and at one, three, and six months post-training.

Secondary outcome [3]

Number of falls using Falls Calendar

Timepoint [3]

Monthly Follow-up after enrolment (up to 12 Months)

Secondary outcome [4]

Functional Independence Measure (FIM)

Timepoint [4]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - Royal Park campus - Parkville

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [3]

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Recruitment hospital [4]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [5]

Royal Talbot Rehabilitation Centre - Kew

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

3081 - Heidelberg West

Recruitment postcode(s) [3]

3084 - Heidelberg

Recruitment postcode(s) [4]

3101 - Kew

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Austin Health

Address [1]

145 Studley Road
Heidelberg Vic 3084

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Melbourne Health

Address [2]

Level 8 South
The Royal Melbourne Hospital
300 Grattan Street
Melbourne Vic 3050

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

The University of Melbourne

Address [3]

Grattan Street
Parkville Vic 3010

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health

Ethics committee address [1]

P.O. Box 5555
Heidelberg Vic 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/06/2016

Ethics approval number [1]

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]

/AnzctrAttachments/371623-20160623 LETTER HREC15Austin516 Jul16 (Ethics approval new study).pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/371623-20161013 LETTER HREC15Austin516 Nov16 ( Ethics approval amendment - protocol).pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Rezaul Begg

Address

Institute of Sport, Exercise and Active Living (ISEAL)
Victoria University, Footscray Park Campus
PO Box 14428
Melbourne Vic 8001

Country

Australia

Phone

+61 3 9919 1116

Fax

Rezaul.Begg@vu.edu.au

Contact person for public queries

Name

Rezaul Begg

Address

Institute of Sport, Exercise and Active Living (ISEAL)
Victoria University, Footscray Park Campus
PO 14428
Melbourne Vic 8001

Country

Australia

Phone

+61 3 9919 1116

Fax

Rezaul.Begg@vu.edu.au

Contact person for scientific queries

Name

Rezaul Begg

Address

Institute of Sport, Exercise and Active Living (ISEAL)
Victoria University, Footscray Park Campus
PO 14428
Melbourne Vic 8001

Country

Australia

Phone

+61 3 9919 1116

Fax

Rezaul.Begg@vu.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Real-time foot clearance biofeedback to assist gait rehabilitation following stroke: A randomized controlled trial protocol.	2019	https://dx.doi.org/10.1186/s13063-019-3404-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically