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Trial registered on ANZCTR

Registration number

ACTRN12617000093381

Ethics application status

Approved

Date submitted

14/01/2017

Date registered

17/01/2017

Date last updated

3/12/2020

Date data sharing statement initially provided

11/02/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

HELLEN: A robot to assist patients with acquired brain injury to stand and exercise

Scientific title

Determining the merits of a lower limb robotic exoskeleton (HELLEN) in stroke rehabilitation

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1191-7043

Trial acronym

HELLEN

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Acquired brain injury

Stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will initially be screened using standard questionnaires and assessment tools. Leg measurements will be taken so that the robotic device can be individually fitted. They will then be put on a 12 week wait list and reassess prior to the commencement of therapy.
The intervention will involve 2 sessions of exercise therapy per week for 12 weeks. Each session will be 1 hour duration and will consist of individualised therapy, prescribed and administered by a physiotherapist, including upright weight-bearing exercise facilitated by HELLEN (a REX Bionics Robotic Exoskeleton - "Hunter's Robotic Exoskeleton for Lower Limb Exercise and Rehabilitation") as tolerated by the patient. This may be a combination of: sit to stand practise, standing tolerance, weight shift, trunk control exercises, stepping practise, side stepping, squats, upper limb exercises and gait practice. Participants will also be provided with a home exercise program relevant to their treatment, which will be updated throughout the trial as required. This will include exercises relevant to each individual maximising their potential in therapy e.g. standing tolerance at a bench with upper limb exercises, squats, transfer practise etc. Frequency of the home exercise program will be 5 days per week, for 20-30 mins per day, and monitored by checking the completed box on attendance records throughout the therapy period of the trial. Measurements will be retaken after 6 weeks of the therapy, after 12 weeks of therapy, and a further 12 weeks after the completion of the program.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Rehabilitation

Comparator / control treatment

Participants will be on a 12 week waitlist to determine their baseline level of function. Participants will be encouraged to continue with their regular therapy during this time, and will be advised that they can contact the researcher at any time should they have queries.

Control group

Active

Outcomes

Primary outcome [1]

Change in Motor Assessment Scale Score

Timepoint [1]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [1]

Change in SF-8 Health Survey Score

Timepoint [1]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [2]

Tardieu scale - gastrocnemius, hamstrings, quadriceps
This is a composite outcome measure.

Timepoint [2]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [3]

Functional Reach Test

Timepoint [3]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [4]

Five times sit to stand

Timepoint [4]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [5]

Grip strength with dynamometer

Timepoint [5]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [6]

Quads strength with dynamometer

Timepoint [6]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [7]

Fatigue assessment scale

Timepoint [7]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [8]

Participant perception of therapy using HELLEN (tool developed by this research team)

Timepoint [8]

Commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [9]

Hospital anxiety and depression scale

Timepoint [9]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [10]

Barthel Index

Timepoint [10]

Assessment at enrolment, commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.

Secondary outcome [11]

Oxygen consumption testing with Cosmed K5 metabolic analyser.

Timepoint [11]

Upon commencement of intervention phase, and end of intervention phase.

Eligibility

Key inclusion criteria

1. Diagnosis of stroke or acquired brain injury atleast 3 months prior
2. Resident of the Hunter region aged 18-90 years
3. Discharged from inpatient rehabilitation services
4. Severe mobility impairment reliant on mobility aid or other people for upright activities

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. weigh >100kg or <40kg; height >6'4" or <4'8" (criteria set by the robotic manufacturer)
2. pregnancy
3. unstable or severe cardiac or respiratory conditions
4. recent fractures in lower limbs/pelvis/spine
5. significant cognitive impairment (<19 on MoCA)
5. Any medical condition which limits the ability to exercise in an upright position

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)

N/A

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

N/A

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

Descriptive statistics, including means and standard deviations, will be calculated for demographic data. A linear mixed model will be used to detect a significant difference between outcome scores during each time period. The value of the baseline score at the start of the trial and after intervention will be used as a covariate, and analysis conducted to correct for differences in baseline scores and to ensure there is no effect of order. All analyses will conducted on an intention to treat basis, with missing follow-up data conservatively imputed using the last observation carried forward method. The MRI data will be analysed using customized software, Differences in metabolite concentration, ASL perfusion and rsfMRI data will be compared at the different time points.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

16/01/2017

Date of last participant enrolment

Anticipated

28/06/2019

Actual

3/05/2019

Date of last data collection

Anticipated

31/03/2020

Actual

18/02/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital - New Lambton

Recruitment hospital [2]

The Maitland Hospital - Maitland

Recruitment hospital [3]

Newcastle Private Hospital - New Lambton Heights

Recruitment hospital [4]

Hunter Valley Private Hospital - Shortland

Recruitment hospital [5]

Maitland Private Hospital - East Maitland

Recruitment hospital [6]

Belmont Hospital - Belmont

Recruitment hospital [7]

Toronto Private Hospital - Toronto

Recruitment hospital [8]

Lingard Private Hospital - Merewether

Recruitment hospital [9]

Tomaree Community Hospital - Nelson Bay

Recruitment hospital [10]

Kurri Kurri District Hospital - Kurri Kurri

Recruitment hospital [11]

Cessnock District Hospital - Cessnock

Recruitment hospital [12]

Warners Bay Private Hospital - Warners Bay

Recruitment postcode(s) [1]

2305 - New Lambton

Recruitment postcode(s) [2]

2320 - Maitland

Recruitment postcode(s) [3]

2305 - New Lambton Heights

Recruitment postcode(s) [4]

2307 - Shortland

Recruitment postcode(s) [5]

2323 - East Maitland

Recruitment postcode(s) [6]

2280 - Belmont

Recruitment postcode(s) [7]

2283 - Toronto

Recruitment postcode(s) [8]

2291 - Merewether

Recruitment postcode(s) [9]

2315 - Nelson Bay

Recruitment postcode(s) [10]

2327 - Kurri Kurri

Recruitment postcode(s) [11]

2325 - Cessnock

Recruitment postcode(s) [12]

2282 - Warners Bay

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Institute of Neuro-rehabilitation (AIN)

Address [1]

Australian Institute of Neuro-rehabilitation, c/o 29 Stockton St, Nelson Bay, NSW, 2315

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

Dr Jodie Marquez, H20, Hunter Building University of Newcastle, University Drive, Callaghan, NSW, 2308

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Hunter Medical Research Institute

Address [1]

HMRI, 1/1 Kookaburra Circuit, New Lambton Heights, NSW, 2305

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Hunter New England Research Ethics & Governance Office
Locked Bag No 1
New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/07/2016

Approval date [1]

11/10/2016

Ethics approval number [1]

HNEHREC Reference No: 16/08/17/4.06

Ethics committee name [2]

Research Integrity Unit - Human Research Ethics Administration

Ethics committee address [2]

Research Integrity Unit
NIER, Block C
The University of Newcastle
Callaghan NSW 2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

31/10/2016

Approval date [2]

25/11/2016

Ethics approval number [2]

H-2016-0413

Summary

Brief summary

For those with severe acquired brain injury, weight-bearing exercise can pose many challenges for both patients and their therapists. Due to physical demands and safety issues, those with severe mobility impairment are often denied the opportunity for weight bearing, task specific training.  This type of training is essential if the recovery of functional abilities such as independent transfers and mobility are to be achieved. 
Advances in robotic technologies have led to the development of wearable lower body exoskeletons. These can be used to assist sit to stand, weight bearing activities and gait. This research team is in the fortunate position to be provided access to an exoskeleton (HELLEN) to research its applicability in people with acquired brain injuries. This device has the potential to assist therapists to increase patient opportunities for weight bearing training at higher intensity and dosage to maximise their potential for recovery. 

This is ground breaking research with no previously published literature on this topic.
Our aim is to examine the potential health benefits and feasibility of using a lower limb exoskeleton as an adjunct tool for neurorehabilitation in those with severe mobility impairment due to acquired brain injury.

This is a Phase I, wait-list controlled trial with 20 participants. Baseline measurements will be taken on enrolment into the study followed by a 12week waitlist period. They will then receive 12 weeks of intervention, provided by a physiotherapist (Nicola Postol). This will involve two 1 hour sessions of individualised upright weight-bearing exercise facilitated by HELLEN, per week. Participants will be provided with a home exercise program, updated throughout the trial as required. Reassessment will occur after 6 and 12 weeks of intervention and after 12 weeks follow-up and will comprise of a battery of impairment, function and quality of life measures.

Trial website

HELLEN.org.au

Trial related presentations / publications

None so far. 4 planned as part of the PhD of one investigator, Nicola Postol.

Public notes

Contacts

Principal investigator

Name

Mrs Nicola Postol

Address

HE14, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308

Country

Australia

Phone

+61 420 506 721

Fax

Nicola.Postol@uon.edu.au

Contact person for public queries

Name

Trish Leonard

Address

Australian Institute of Neuro-rehabilitation, c/o 29 Stockton St, Nelson Bay, NSW, 2315

Country

Australia

Phone

+61 498 479 422

Fax

info@ain-rehab.org.au

Contact person for scientific queries

Name

Dr Jodie Marquez

Address

HC20, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308

Country

Australia

Phone

+61 2 4921 2041

Fax

jodie.marquez@newcastle.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All data.

When will data be available (start and end dates)?

Data will be available from the time of publication until 5 years after the publication date.

Available to whom?

It will be made available on request from researchers, and upon our confirmation that they comply with ethical procedures for data management, storage and disposal.

Available for what types of analyses?

We will provide de-identified individual participant data for demographic data and all outcome data which we assessed at all time points. The type of analysis conducted with this data will be at the discretion of the secondary team of researchers.

How or where can data be obtained?

Access is at the approval of the research team.
It will be provided in response to a direct request via correspondence to the research team. The means of provision will be decided through consultation with the research team eg secure server such as Owncloud.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3856	Study protocol			Nicola.Postol@uon.edu.au
3857	Ethical approval			Nicola.Postol@uon.edu.au

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	The Metabolic Cost of Exercising with a Robotic Exoskeleton: A Comparison of Healthy and Neurologically Impaired People.	2020	https://dx.doi.org/10.1109/TNSRE.2020.3039202

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

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