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Trial registered on ANZCTR


Registration number
ACTRN12618000626268
Ethics application status
Approved
Date submitted
5/04/2018
Date registered
20/04/2018
Date last updated
7/08/2019
Date data sharing statement initially provided
22/03/2019
Date results information initially provided
7/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SIR HELLEN
(Spinal Cord InjuRy in the Hunter's Exoskeleton for Lower Limb Exercise and Neurorehabilitation)
Scientific title
Determining the effect on functional ability and quality of life of a lower limb robotic exoskeleton in patients with Spinal cord InjuRy (SIR HELLEN).
Secondary ID [1] 294504 0
None
Universal Trial Number (UTN)
U1111-1211-8174
Trial acronym
SIR HELLEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 307277 0
Condition category
Condition code
Neurological 306395 306395 0 0
Other neurological disorders
Injuries and Accidents 306568 306568 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are assisted to transfer into the device, which is basically a pair of robot pants, and are then strapped into it. 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 Rex Robotic accredited physiotherapist. This will entail upright weight-bearing exercise facilitated by the device (HELLEN) as tolerated by the participant and will 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 practise. These exercises will be individually tailored to meet the abilities and needs of the client. Participants will also be provided with a short home exercise program (not in HELLEN) relevant to their treatment (requiring no more than half an hour per day), which will be reviewed and amended as required monthly during the therapy phase. Patients will be asked to self report participation in their home exercise program.
Interventions will only be progressed according to the individual participants’ abilities as deemed appropriate by the administering physiotherapist. Interventions will be modified or ceased if, in communication with the participant, the researchers deem that this is necessary.
Intervention code [1] 300799 0
Treatment: Devices
Comparator / control treatment
This trial has a 12 week observation period from week 0 to week 12 during which the participants will continue to receive their usual care. These are the same participants receiving the intervention from week 12. Intervention commences after the 12 week waiting period.

Usual care means that the participants are able to continue with their usual home exercise programs, sessions with health professionals and out-patient rehabilitation, exactly as they were prior to assessment.
Control group
Active

Outcomes
Primary outcome [1] 305406 0
Functional ability as measured by the Spinal Cord Independence Measure (SCIM-III)
Timepoint [1] 305406 0
0, 12, 18, 24, 36 weeks after enrolment.

The primary timepoint is at week 24.
Secondary outcome [1] 345078 0
Mood - Hospital Anxiety and Depression Scale
Timepoint [1] 345078 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [2] 345079 0
Fatigue - Fatigue Assessment Scale
Timepoint [2] 345079 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [3] 345080 0
Spasticity - Tardieu scale
Timepoint [3] 345080 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [4] 345081 0
Endurance: Five times sit to stand test
Timepoint [4] 345081 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [5] 345082 0
Ambulation function (Lower extremity motor scale: LEMS)
Timepoint [5] 345082 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [6] 345083 0
Health related quality of life (Short form 8: SF8)
Timepoint [6] 345083 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [7] 345084 0
Strength of grip (Dynamometer assessment)
Timepoint [7] 345084 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [8] 345085 0
Body composition (Bioelectrical impedance analysis)
Timepoint [8] 345085 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [9] 345086 0
Perceptions of Robotic Therapy - questionnaire developed by this research team
Timepoint [9] 345086 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [10] 345638 0
Quads strength testing with dynamometer
Timepoint [10] 345638 0
0, 12, 18, 24, 36 weeks after enrolment.
Secondary outcome [11] 345639 0
Functional balance: Functional Reach Test
Timepoint [11] 345639 0
0, 12, 18, 24, 36 weeks after enrolment.

Eligibility
Key inclusion criteria
1. Diagnosis of traumatic or non-traumatic SCI at least 3 months prior to enrolment
2. Resident of the Hunter region
3. 18 years of age or older
4. Discharged from inpatient rehabilitation programs
5. Severe mobility impairment and reliant on wheelchair, mobility aid, or the assistance of others for standing activities ( scores < /=5 on the mobility assessment of SCIM-III)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Weight between 40 kg and 100kg; height between 4’8” and 6'4" (as per the recommendations of the robotic manufacturer)
2. Pregnancy
3. Unstable or severe cardiac or respiratory compromise
4. Nonconsolidated fractures in lower limbs/pelvis/spine or diagnosed severe osteopenia ( t-score less than or equal to -2.5)
5. Significant cognitive impairment (Montreal Cognitive Assessment Score of less than 19)
6. Any medical condition which limits the ability to exercise in an upright position. This includes: pressure sores in contact with the exoskeleton, lower limb heterotrophic ossification, severe lower limb muscle contracture, spinal instability, acute deep vein thrombosis, recurrent attacks of autonomic dysreflexia requiring medical intervention, hip subluxation, a history of pathological fractures in the lower limbs in the last 2 years)

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)
Allocation was unconcealed
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 (SD), will be calculated for demographic and outcome data. Change scores for each outcome from baseline will be tested using independent t tests for continuous variables and Chi square tests for categorical variables. Differences from enrolment, baseline, mid intervention, post intervention and 12-week follow up will be evaluated for statistical significance. All analyses will be conducted on an intention-to-treat basis, with missing follow-up 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] 10561 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 10562 0
Belmont Hospital - Belmont
Recruitment hospital [3] 10563 0
The Maitland Hospital - Maitland
Recruitment hospital [4] 10564 0
Tomaree Community Hospital - Nelson Bay
Recruitment hospital [5] 10565 0
Singleton District Hospital - Singleton
Recruitment hospital [6] 10566 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [7] 10567 0
Warners Bay Private Hospital - Warners Bay
Recruitment hospital [8] 10568 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [9] 10569 0
Lingard Private Hospital - Merewether
Recruitment hospital [10] 10570 0
Hunter Valley Private Hospital - Shortland
Recruitment hospital [11] 10571 0
Maitland Private Hospital - East Maitland
Recruitment postcode(s) [1] 22280 0
2305 - New Lambton
Recruitment postcode(s) [2] 22281 0
2280 - Belmont
Recruitment postcode(s) [3] 22282 0
2320 - Maitland
Recruitment postcode(s) [4] 22283 0
2315 - Nelson Bay
Recruitment postcode(s) [5] 22284 0
2330 - Singleton
Recruitment postcode(s) [6] 22285 0
2290 - Gateshead
Recruitment postcode(s) [7] 22286 0
2282 - Warners Bay
Recruitment postcode(s) [8] 22287 0
2305 - New Lambton Heights
Recruitment postcode(s) [9] 22288 0
2291 - Merewether
Recruitment postcode(s) [10] 22289 0
2747 - Shortland
Recruitment postcode(s) [11] 22290 0
2323 - East Maitland

Funding & Sponsors
Funding source category [1] 299130 0
Charities/Societies/Foundations
Name [1] 299130 0
Australian Institute of Neuro-rehabiliation (AIN)
Address [1] 299130 0
Australian Institute of Neuro-rehabilitation
c/o 29 Stockton St, Nelson Bay, NSW, 2315
Country [1] 299130 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] 298388 0
None
Name [1] 298388 0
Address [1] 298388 0
Country [1] 298388 0
Other collaborator category [1] 280050 0
Other
Name [1] 280050 0
Hunter Spinal Cord Injury Service
Address [1] 280050 0
Hunter Spinal Cord Injury Service
621 Hunter Street Health Centre, 621 Hunter Street, NEWCASTLE WEST NSW 2302
Country [1] 280050 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300062 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 300062 0
Hunter New England Research and Ethics Governance Office,
Locked Bag No 1, New Lambton, NSW, 2305
Ethics committee country [1] 300062 0
Australia
Date submitted for ethics approval [1] 300062 0
27/04/2018
Approval date [1] 300062 0
06/07/2018
Ethics approval number [1] 300062 0
HNEHREC Reference No: 18/06/20/4.04 NSW REGIS Reference No: 2018/ETH00141

Summary
Brief summary
Each year in Australia 300-400 new cases of Spinal Cord Injury (SCI) are reported with prevalence predicted to continue to increase with population growth and improved medical care. The most obvious consequence of SCI is paralysis however it also has an impact on many other body functions as well, including social, financial and psychological implications. Most long-term wheelchair users adopt a sedentary lifestyle with prolonged sitting and limited opportunities to engage in physical activities. As a result, many people with SCI experience progressive physical deconditioning and its associated multifactorial health consequences such as diabetes and hyperlipidaemia. This contributes to loss of functional ability and the increased risk of cardiovascular morbidity and mortality.
Physiotherapy during rehabilitation focuses on goals related to improving functional ability such as walking, transferring, propelling a wheelchair, balance and upper limb usage. This involves the management of weakness, reduced range of movement, decreased fitness, pain, and respiratory compromise. For those patients with paralysis there is often great difficulty in assisting them to stand and support their body weight. It places a substantial burden on therapists who must assist the patient into standing whilst trying to facilitate exercise and prevent falls. Therefore, these patients are often denied opportunity for the intense, functional therapy this is required to produce positive outcomes.
The development of robotic exoskeletons has the potential to overcome the current limitations to therapy. These overground exoskeletons provide motorised assistance at the hips, knees and ankles via motors and coordinate movements at these joints to produce or assist with standing, upright exercises, and walking. They can be used to make gait training, transfer training, and balance training, easier and provide a safe opportunity for intensive practice related to standing and strenuous exercise. There are many different types of robotic exoskeletons currently available but there is no published evidence investigating the patient benefits of using the REX Bionics exoskeleton (HELLEN) as a rehabilitation tool. We aim to examine the potential benefits of using this device as an adjunct tool for rehabilitation in people with SCI. This data will be compared to data being collected in adjacent trials in Stroke and Multiple Sclerosis, currently being conducted by this research team.
Trial website
hellen.org.au
Trial related presentations / publications
Public notes
The REX Bionics exoskeleton has been provided in kind for research purposes to the University of Newcastle by the Australian Institute of Neuro-rehabilitation.

Contacts
Principal investigator
Name 68754 0
Mrs Nicola Postol
Address 68754 0
HE14, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 68754 0
Australia
Phone 68754 0
+61 420 506 721
Fax 68754 0
Email 68754 0
Nicola.Postol@uon.edu.au
Contact person for public queries
Name 68755 0
Mrs Nicola Postol
Address 68755 0
HE14, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 68755 0
Australia
Phone 68755 0
+61 420 506 721
Fax 68755 0
Email 68755 0
Nicola.Postol@uon.edu.au
Contact person for scientific queries
Name 68756 0
Dr Jodie Marquez
Address 68756 0
HC20, Hunter Building, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 68756 0
Australia
Phone 68756 0
+61 2 4921 2041
Fax 68756 0
Email 68756 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 outcome 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?
A request for data should be made to the author for correspondence listed on the publication corresponding to this trial. 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] 3851 0
Study protocol
Citation [1] 3851 0
Link [1] 3851 0
Email [1] 3851 0
Nicola.Postol@uon.edu.au
Other [1] 3851 0
Attachment [1] 3851 0
Type [2] 3852 0
Ethical approval
Citation [2] 3852 0
Link [2] 3852 0
Email [2] 3852 0
Nicola.Postol@uon.edu.au
Other [2] 3852 0
Attachment [2] 3852 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