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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
7/08/2019
Date data sharing statement initially provided
11/02/2019
Date results information initially provided
7/08/2019
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] 290919 0
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 301641 0
Stroke 301655 0
Condition category
Condition code
Stroke 301343 301343 0 0
Haemorrhagic
Stroke 301344 301344 0 0
Ischaemic
Neurological 301345 301345 0 0
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] 296860 0
Treatment: Devices
Intervention code [2] 296861 0
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] 300748 0
Change in Motor Assessment Scale Score
Timepoint [1] 300748 0
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] 330778 0
Change in SF-8 Health Survey Score
Timepoint [1] 330778 0
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] 373625 0
Tardieu scale - gastrocnemius, hamstrings, quadriceps
This is a composite outcome measure.
Timepoint [2] 373625 0
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] 373626 0
Functional Reach Test
Timepoint [3] 373626 0
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] 373627 0
Five times sit to stand
Timepoint [4] 373627 0
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] 373628 0
Grip strength with dynamometer
Timepoint [5] 373628 0
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] 373629 0
Quads strength with dynamometer
Timepoint [6] 373629 0
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] 373630 0
Fatigue assessment scale
Timepoint [7] 373630 0
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] 373631 0
Participant perception of therapy using HELLEN (tool developed by this research team)
Timepoint [8] 373631 0
Commencement of 12 week therapy period, 6 weeks into therapy, end of therapy (12 weeks), 12 weeks after therapy ends.
Secondary outcome [9] 373632 0
Hospital anxiety and depression scale
Timepoint [9] 373632 0
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] 373633 0
Barthel Index
Timepoint [10] 373633 0
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] 373634 0
Oxygen consumption testing with Cosmed K5 metabolic analyser.
Timepoint [11] 373634 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7304 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 7305 0
The Maitland Hospital - Maitland
Recruitment hospital [3] 7306 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [4] 7307 0
Hunter Valley Private Hospital - Shortland
Recruitment hospital [5] 7308 0
Maitland Private Hospital - East Maitland
Recruitment hospital [6] 7309 0
Belmont Hospital - Belmont
Recruitment hospital [7] 7310 0
Toronto Private Hospital - Toronto
Recruitment hospital [8] 7311 0
Lingard Private Hospital - Merewether
Recruitment hospital [9] 7312 0
Tomaree Community Hospital - Nelson Bay
Recruitment hospital [10] 7313 0
Kurri Kurri District Hospital - Kurri Kurri
Recruitment hospital [11] 7314 0
Cessnock District Hospital - Cessnock
Recruitment hospital [12] 7315 0
Warners Bay Private Hospital - Warners Bay
Recruitment postcode(s) [1] 15084 0
2280 - Belmont
Recruitment postcode(s) [2] 15090 0
2282 - Warners Bay
Recruitment postcode(s) [3] 15085 0
2283 - Toronto
Recruitment postcode(s) [4] 15086 0
2291 - Merewether
Recruitment postcode(s) [5] 15079 0
2305 - New Lambton
Recruitment postcode(s) [6] 15081 0
2305 - New Lambton Heights
Recruitment postcode(s) [7] 15082 0
2307 - Shortland
Recruitment postcode(s) [8] 15087 0
2315 - Nelson Bay
Recruitment postcode(s) [9] 15080 0
2320 - Maitland
Recruitment postcode(s) [10] 15083 0
2323 - East Maitland
Recruitment postcode(s) [11] 15089 0
2325 - Cessnock
Recruitment postcode(s) [12] 15088 0
2327 - Kurri Kurri

Funding & Sponsors
Funding source category [1] 295337 0
Charities/Societies/Foundations
Name [1] 295337 0
Australian Institute of Neuro-rehabilitation (AIN)
Address [1] 295337 0
Australian Institute of Neuro-rehabilitation, c/o 29 Stockton St, Nelson Bay, NSW, 2315
Country [1] 295337 0
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] 294173 0
Other
Name [1] 294173 0
Hunter Medical Research Institute
Address [1] 294173 0
HMRI, 1/1 Kookaburra Circuit, New Lambton Heights, NSW, 2305
Country [1] 294173 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296674 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 296674 0
Hunter New England Research Ethics & Governance Office
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 296674 0
Australia
Date submitted for ethics approval [1] 296674 0
22/07/2016
Approval date [1] 296674 0
11/10/2016
Ethics approval number [1] 296674 0
HNEHREC Reference No: 16/08/17/4.06
Ethics committee name [2] 296675 0
Research Integrity Unit - Human Research Ethics Administration
Ethics committee address [2] 296675 0
Research Integrity Unit
NIER, Block C
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [2] 296675 0
Australia
Date submitted for ethics approval [2] 296675 0
31/10/2016
Approval date [2] 296675 0
25/11/2016
Ethics approval number [2] 296675 0
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 71730 0
Mrs Nicola Postol
Address 71730 0
HE14, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 71730 0
Australia
Phone 71730 0
+61 420 506 721
Fax 71730 0
Email 71730 0
Nicola.Postol@uon.edu.au
Contact person for public queries
Name 71731 0
Mrs Trish Leonard
Address 71731 0
Australian Institute of Neuro-rehabilitation, c/o 29 Stockton St, Nelson Bay, NSW, 2315
Country 71731 0
Australia
Phone 71731 0
+61 498 479 422
Fax 71731 0
Email 71731 0
info@ain-rehab.org.au
Contact person for scientific queries
Name 71732 0
Mrs Dr Jodie Marquez
Address 71732 0
HC20, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 71732 0
Australia
Phone 71732 0
+61 2 4921 2041
Fax 71732 0
Email 71732 0
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?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3856 0
Study protocol
Citation [1] 3856 0
Link [1] 3856 0
Email [1] 3856 0
Nicola.Postol@uon.edu.au
Other [1] 3856 0
Attachment [1] 3856 0
Type [2] 3857 0
Ethical approval
Citation [2] 3857 0
Link [2] 3857 0
Email [2] 3857 0
Nicola.Postol@uon.edu.au
Other [2] 3857 0
Attachment [2] 3857 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary