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Trial registered on ANZCTR


Registration number
ACTRN12617001316392
Ethics application status
Approved
Date submitted
4/09/2017
Date registered
13/09/2017
Date last updated
7/08/2019
Date data sharing statement initially provided
7/08/2019
Date results information initially provided
7/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the merits of a lower limb robotic exoskeleton (HELLEN) in patients with Multiple Sclerosis
Scientific title
A phase 1 pre-post intervention trial with 12 week baseline control determining the merits of a lower limb robotic exoskeleton (HELLEN) in the rehabilitation of Multiple Sclerosis (MS).
Secondary ID [1] 292809 0
Nil known
Universal Trial Number (UTN)
U1111-1201-6696
Trial acronym
MS HELLEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis 304627 0
Condition category
Condition code
Neurological 303946 303946 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 303978 303978 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HELLEN is a REX Bionics Exoskeleton which in lay terms is like a pair of robotic legs, which the user is strapped into. The straps are at the shins, thighs, abdomen, and around the hips. The user is fitted to the device whilst the device is in sitting. The user will transfer in their usual way into the device. A hoist is available if this is necessary.

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 an experienced 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. It will not involve exercise in the device. 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] 299054 0
Treatment: Devices
Intervention code [2] 299055 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] 303292 0
Function - Motor Assessment Scale
Timepoint [1] 303292 0
Baseline
12 weeks later at commencement of therapy phase
At 18 weeks (6 weeks into therapy phase)
At 24 weeks (at end of therapy phase)
At 36 weeks (12 week follow up)
Secondary outcome [1] 338542 0
Change in SF-8 Health Survey Score
Timepoint [1] 338542 0
Baseline
12 weeks later at commencement of therapy phase
At 18 weeks (6 weeks into therapy phase)
At 24 weeks (at end of therapy phase)
At 36 weeks (12 week follow up)
Secondary outcome [2] 338543 0
Body composition with Bioelectrical Impedance Analysis
Timepoint [2] 338543 0
Baseline
12 weeks later at commencement of therapy phase
At 18 weeks (6 weeks into therapy phase)
At 24 weeks (at end of therapy phase)
At 36 weeks (12 week follow up)
Secondary outcome [3] 373613 0
Tardieu scale - gastrocnemius, hamstrings and quadriceps
(composite secondary outcome)
Timepoint [3] 373613 0
Baseline 12 weeks later at commencement of therapy phase At 18 weeks (6 weeks into therapy phase) At 24 weeks (at end of therapy phase) At 36 weeks (12 week follow up)
Secondary outcome [4] 373614 0
Functional Reach Test
Timepoint [4] 373614 0
Baseline 12 weeks later at commencement of therapy phase At 18 weeks (6 weeks into therapy phase) At 24 weeks (at end of therapy phase) At 36 weeks (12 week follow up)
Secondary outcome [5] 373615 0
Five times sit to stand
Timepoint [5] 373615 0
Baseline 12 weeks later at commencement of therapy phase At 18 weeks (6 weeks into therapy phase) At 24 weeks (at end of therapy phase) At 36 weeks (12 week follow up)
Secondary outcome [6] 373616 0
Grip strength using dynamometer
Timepoint [6] 373616 0
Baseline 12 weeks later at commencement of therapy phase At 18 weeks (6 weeks into therapy phase) At 24 weeks (at end of therapy phase) At 36 weeks (12 week follow up)
Secondary outcome [7] 373617 0
Quads strength testing using dynamometer
Timepoint [7] 373617 0
Baseline 12 weeks later at commencement of therapy phase At 18 weeks (6 weeks into therapy phase) At 24 weeks (at end of therapy phase) At 36 weeks (12 week follow up)
Secondary outcome [8] 373618 0
Fatigue assessment scale
Timepoint [8] 373618 0
Baseline 12 weeks later at commencement of therapy phase At 18 weeks (6 weeks into therapy phase) At 24 weeks (at end of therapy phase) At 36 weeks (12 week follow up)
Secondary outcome [9] 373619 0
Participant perception of therapy using HELLEN
(tool designed by this research team)
Timepoint [9] 373619 0
Commencement of therapy phase At 18 weeks (6 weeks into therapy phase) At 24 weeks (at end of therapy phase) At 36 weeks (12 week follow up)
Secondary outcome [10] 373620 0
Hospital anxiety and depression scale
Timepoint [10] 373620 0
Baseline 12 weeks later at commencement of therapy phase At 18 weeks (6 weeks into therapy phase) At 24 weeks (at end of therapy phase) At 36 weeks (12 week follow up)
Secondary outcome [11] 373621 0
Barthel index
Timepoint [11] 373621 0
Baseline 12 weeks later at commencement of therapy phase At 18 weeks (6 weeks into therapy phase) At 24 weeks (at end of therapy phase) At 36 weeks (12 week follow up)
Secondary outcome [12] 373622 0
Oxygen consumption testing with Cosmed K5 metabolic analyser.
Timepoint [12] 373622 0
Beginning of intervention phase, and end of intervention phase.

Eligibility
Key inclusion criteria
1. Diagnosis of MS
2. Resident of the Hunter region over the age of 18 years
3. Severe mobility impairment whereby the participant is reliant on a mobility aid or other people for upright activities (Scores >6 on the Expanded Disability Status Scale)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Weight >100kg or <40kg; height >6'4" or <4'8" (criteria set by the REX Bionics)
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)
6. 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 followup data conservatively imputed using the last observation carried forward method.

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] 8947 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 8948 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 8949 0
Belmont Hospital - Belmont
Recruitment hospital [4] 8950 0
The Maitland Hospital - Maitland
Recruitment hospital [5] 8951 0
Maitland Private Hospital - East Maitland
Recruitment hospital [6] 8952 0
Hunter Valley Private Hospital - Shortland
Recruitment hospital [7] 8953 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [8] 8954 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [9] 8955 0
Warners Bay Private Hospital - Warners Bay
Recruitment hospital [10] 8956 0
Lingard Private Hospital - Merewether
Recruitment hospital [11] 8957 0
Toronto Private Hospital - Toronto
Recruitment hospital [12] 8958 0
Tomaree Community Hospital - Nelson Bay
Recruitment postcode(s) [1] 17321 0
2280 - Belmont
Recruitment postcode(s) [2] 17327 0
2282 - Warners Bay
Recruitment postcode(s) [3] 17329 0
2283 - Toronto
Recruitment postcode(s) [4] 17326 0
2290 - Gateshead
Recruitment postcode(s) [5] 17328 0
2291 - Merewether
Recruitment postcode(s) [6] 17320 0
2298 - Waratah
Recruitment postcode(s) [7] 17319 0
2305 - New Lambton
Recruitment postcode(s) [8] 17325 0
2305 - New Lambton Heights
Recruitment postcode(s) [9] 17324 0
2307 - Shortland
Recruitment postcode(s) [10] 17330 0
2315 - Nelson Bay
Recruitment postcode(s) [11] 17322 0
2320 - Maitland
Recruitment postcode(s) [12] 17323 0
2323 - East Maitland

Funding & Sponsors
Funding source category [1] 297439 0
Charities/Societies/Foundations
Name [1] 297439 0
Australian Institute of Neuro-rehabilitation
Address [1] 297439 0
Australian Institute of Neuro-rehabilitation, c/o 29 Stockton St, Nelson Bay, NSW, 2315
Country [1] 297439 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] 296436 0
Other
Name [1] 296436 0
Hunter Medical Research Institute
Address [1] 296436 0
HMRI, 1/1 Kookaburra Circuit, New Lambton Heights, NSW, 2305
Country [1] 296436 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298548 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 298548 0
Hunter New England Research Ethics & Governance Office
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 298548 0
Australia
Date submitted for ethics approval [1] 298548 0
24/07/2017
Approval date [1] 298548 0
01/09/2017
Ethics approval number [1] 298548 0
17/08/16/4.02

Summary
Brief summary
For those with Multiple Sclerosis (MS), 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 MS, having already commenced a sister trial with participants with Acquired Brain Injury. 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 with this device. 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 MS. 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
Public notes
Attachments [1] 2016 2016 0 0

Contacts
Principal investigator
Name 77422 0
Ms Nicola Postol
Address 77422 0
HE14, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 77422 0
Australia
Phone 77422 0
+61 420 506 721
Fax 77422 0
Email 77422 0
Nicola.Postol@uon.edu.au
Contact person for public queries
Name 77423 0
Mrs Nicola Postol
Address 77423 0
HE14, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 77423 0
Australia
Phone 77423 0
+61 420 506 721
Fax 77423 0
Email 77423 0
Nicola.Postol@uon.edu.au
Contact person for scientific queries
Name 77424 0
Mrs Jodie Marquez
Address 77424 0
HC20, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 77424 0
Australia
Phone 77424 0
+61 2 4921 2041
Fax 77424 0
Email 77424 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 of the individual participant data collected during the trial
When will data be available (start and end dates)?
Data will be made 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 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 discrection 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 direct correspondence to the research team. The means of provision will be decided through consultation with he research team, e.g. 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] 3663 0
Study protocol
Citation [1] 3663 0
Link [1] 3663 0
Email [1] 3663 0
Nicola.Postol@uon.edu.au
Other [1] 3663 0
Upon request to Nicola.Postol@uon.edu.au
Attachment [1] 3663 0
Type [2] 3664 0
Ethical approval
Citation [2] 3664 0
Link [2] 3664 0
Email [2] 3664 0
Nicola.Postol@uon.edu.au
Other [2] 3664 0
Upon request to Nicola.Postol@uon.edu.au
Attachment [2] 3664 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