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Trial registered on ANZCTR


Registration number
ACTRN12620000083998p
Ethics application status
Not yet submitted
Date submitted
28/11/2019
Date registered
31/01/2020
Date last updated
31/01/2020
Date data sharing statement initially provided
31/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing weight-bearing exercise to prevent bone loss in post-stroke patients using robot-assisted rehabilitation
Scientific title
Increasing weight-bearing exercise to prevent bone loss in post-stroke patients using robot-assisted rehabilitation
Secondary ID [1] 299947 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 315394 0
Condition category
Condition code
Stroke 313690 313690 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 314087 314087 0 0
Physiotherapy
Stroke 314197 314197 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A new model of care for stroke rehabilitation, using mechanobiology-based, robot-assisted weight-bearing exercise with biofeedback to improve bone health in patients following an acute stroke
a) Robot-assisted exercise: The robot can provide physical support of lower limbs during sit-to-stand and stand-to-sit transfers. With waist, knees and feet firmly fastened and protected, the patients can perform sit-to-stand exercise.

b) During sit-to-stand exercise, the biofeedback device compares the foot reaction force with two preset thresholds and emits audible feedback tones to guide the patient in maintaining certain speed of sit-to-stand which results in the load within the predicted lower threshold and upper threshold

c) & d) Robot-assisted weight-bearing exercise commenced within one month of stroke for a period of 12 months (three training sessions weekly for the first three months and one training session weekly for the remaining 9 months). Each sit-to-stand training session lasts up to 60 mins with a minimum of 6 sets (15 repetitions per set with 3 mins rest between sets)

e) The mode of administration: group of 4

f) Supervision: physiotherapist & research assistant

g) At the time point of three month, the feasibility and safety of the intervention will be assessed.

h) Monitor adherence to the intervention: attendance check lists and reminder text messages
Intervention code [1] 316213 0
Rehabilitation
Intervention code [2] 316596 0
Treatment: Other
Comparator / control treatment
Control Group is standard care in a rehabilitation facility of a hospital or in a home setting following 2017 clinical guidelines for stroke management.
Control group
Active

Outcomes
Primary outcome [1] 322120 0
The feasibility of ward-based robot-assisted rehabilitation: Surveys with closed and open-ended questions will be designed and used to measure the perceptions of patients
Timepoint [1] 322120 0
6 months post-treatment commencement,
Primary outcome [2] 322479 0
Bone mineral density: dual-energy X-ray absorptiometry
Timepoint [2] 322479 0
6 and 12 months post-treatment commencement, respectively
Primary outcome [3] 322480 0
Potential cost-effectiveness of robot-assisted rehabilitation compared to standard care: cost data collection from hospital records and study-specific survey results.
Timepoint [3] 322480 0
12 months post-treatment commencement
Secondary outcome [1] 378656 0
composite secondary outcome: Process evaluation and protocol fidelity: conduct focus groups with hospital staff and participants (i.e. engagement, satisfaction). 60 minutes, groups of 3 open-ended, audio-recorded
Timepoint [1] 378656 0
12 months post-treatment commencement,
Secondary outcome [2] 378657 0
Appendicular lean mass: Whole-body dual-energy X-ray absorptiometry scans
Timepoint [2] 378657 0
12 months post-treatment commencement,
Secondary outcome [3] 378658 0
Gait endurance: 6-min walk test
Timepoint [3] 378658 0
3, 6 and 12 months post-treatment commencement, respectively
Secondary outcome [4] 378659 0
Motor impairment: physical performance battery (scores ranging 0–10)
Timepoint [4] 378659 0
3, 6 and 12 months post-treatment commencement, respectively

Eligibility
Key inclusion criteria
(1) age >=18 years old, (2) first ever stroke, (3) hospital admission <2 weeks post stroke and (4) Functional Independence Measure scores of 1–4 (total dependence) on both the locomotor and transfer items at time of admission.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) survival expected to be >=12 months, (2) a cerebellar, bilateral or brainstem stroke that makes it unsafe to operate the robotic device, (3) unable to understand two-part commands due to language or cognitive deficits, (4) neuromuscular condition other than stroke (e.g. Parkinson’s disease or multiple sclerosis), (5) orthopaedic limitations (e.g. severe lower extremity contractures, primary fragility fractures or moderate to severe osteoporosis), (6) bilateral upper limb motor impairment post stroke, (7) hip replacement history, (8) any condition that precludes participation in weight-bearing exercises.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)
VIC

Funding & Sponsors
Funding source category [1] 304412 0
Government body
Name [1] 304412 0
National Health and Medical Research Council
Address [1] 304412 0
GPO Box 1421, CANBERRA ACT 2601
Country [1] 304412 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton Victoria 3168, Australia
Country
Australia
Secondary sponsor category [1] 304668 0
Hospital
Name [1] 304668 0
Epworth HealthCare
Address [1] 304668 0
89 Bridge Road
Richmond VIC 3121, Australia
Country [1] 304668 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304846 0
Monash Health Clinical Ethics Committee
Ethics committee address [1] 304846 0
246 Clayton Road, Clayton Victoria 3168
Ethics committee country [1] 304846 0
Australia
Date submitted for ethics approval [1] 304846 0
31/08/2020
Approval date [1] 304846 0
Ethics approval number [1] 304846 0

Summary
Brief summary
The purpose of this partnership project is to address a significant evidence-to-practice gap by implementing and evaluating a new model of care for stroke rehabilitation, using mechanobiology-based, robot-assisted weight-bearing exercise with biofeedback to improve bone health in patients following an acute stroke.

Hypothesis:: Relative to standard care, the new model of care for stroke patients utilising a mechanobiology-based robot-assisted weight-bearing exercise will achieve significant and sustainable improvements in bone health consistent with that recommended by the 2017 clinical guidelines for stroke management.

This project will provide the necessary comparative-effectiveness ‘proof-of-concept’ evidence for the use of robots in clinical practice to inform rehabilitation policy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98390 0
A/Prof Lihai Zhang
Address 98390 0
Department of Infrastructure Engineering
The University of Melbourne
Parkville, Victoria 3010, Australia
Country 98390 0
Australia
Phone 98390 0
+61 3 83447179
Fax 98390 0
None
Email 98390 0
lihzhang@unimelb.edu.au
Contact person for public queries
Name 98391 0
A/Prof Lihai Zhang
Address 98391 0
Department of Infrastructure Engineering
The University of Melbourne
Parkville, Victoria 3010, Australia
Country 98391 0
Australia
Phone 98391 0
+61 3 83447179
Fax 98391 0
None
Email 98391 0
lihzhang@unimelb.edu.au
Contact person for scientific queries
Name 98392 0
A/Prof Lihai Zhang
Address 98392 0
Department of Infrastructure Engineering
Melbourne School of Engineering
The University of Melbourne
Parkville, Victoria 3010, Australia
Country 98392 0
Australia
Phone 98392 0
+61 3 83447179
Fax 98392 0
Email 98392 0
lihzhang@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6382 0
Study protocol
Citation [1] 6382 0
Link [1] 6382 0
Email [1] 6382 0
lihzhang@unimelb.edu.au
Other [1] 6382 0
Attachment [1] 6382 0
Type [2] 6383 0
Statistical analysis plan
Citation [2] 6383 0
Link [2] 6383 0
Email [2] 6383 0
lihzhang@unimelb.edu.au
Other [2] 6383 0
Attachment [2] 6383 0
Type [3] 6384 0
Informed consent form
Citation [3] 6384 0
Link [3] 6384 0
Email [3] 6384 0
lihzhang@unimelb.edu.au
Other [3] 6384 0
Attachment [3] 6384 0
Type [4] 6385 0
Clinical study report
Citation [4] 6385 0
Link [4] 6385 0
Email [4] 6385 0
lihzhang@unimelb.edu.au
Other [4] 6385 0
Attachment [4] 6385 0
Type [5] 6386 0
Ethical approval
Citation [5] 6386 0
Link [5] 6386 0
Email [5] 6386 0
lihzhang@unimelb.edu.au
Other [5] 6386 0
Attachment [5] 6386 0
Summary results
No Results