Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000378426
Ethics application status
Approved
Date submitted
28/03/2025
Date registered
29/04/2025
Date last updated
29/04/2025
Date data sharing statement initially provided
29/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Robotic Arm Intervention for Stroke rEcovery (RAISE): A pilot randomised controlled trial
Scientific title
Robotic Arm Intervention for Stroke rEcovery (RAISE): A pilot randomised controlled trial evaluating the efficacy of a novel exoskeleton device for improving upper limb impairment post stroke
Secondary ID [1] 312047 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RAISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 333693 0
Condition category
Condition code
Stroke 330373 330373 0 0
Haemorrhagic
Stroke 330372 330372 0 0
Ischaemic
Physical Medicine / Rehabilitation 333586 333586 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive a minimum of 40 hours additional therapy delivered five days per week (Mon-Fri) over four weeks, equating to approximately two hours per day. This therapy will be comprised of task specific motor training (75mins) and robotic therapy (45mins) delivered by a trained occupational therapist or physiotherapist. Task specific motor training will be delivered using a specifically developed manual, tailored to the individual's abilities. Activities will include tasks such as reaching for a cup to practice shoulder forward flexion and external rotation or attaching pegs to a line to practice train finger dexterity. Each activity within the manual has pre-planned levels of difficulty and modifications that may be enacted in order to individualise the activity to the participants ability.

Robotic therapy will be delivered using a portable robotic exoskeleton with real time visual biofeedback and electromyography (EMG) activation (see doi: 10.1186/s12984-021-00867-7). The device is comprised of a forearm and hand support and simple visual display. Participants will be asked to attempt to extend their wrist and fingers. The EMG sensor will register muscle activity as the person attempts the movement, activating the device and moving the hand into wrist and finger extension.

Intervention will primarily be delivered within a clinical setting, with the option for intervention delivery in the participant's home or via telehealth as required at the discretion of the site investigator. In clinical settings, therapy may be delivered using a combination of individual and semi-supervised sessions (with up to three participants: 1 therapist).

Program adherence data will be collected by recording the duration of sessions (time spent active vs inactive), level of difficulty of therapy tasks (as reported by participants) and amount of repetitions completed.

Acceptability of the high dose motor retraining program will be measured via i) the theoretical framework of acceptability (TFA) questionnaire, which consists of seven component constructs of acceptability of an intervention and an overall acceptability measure and ii) The 10 question System Usability Scale (SUS), a validated tool, which measures a users’ experience of technology. This data will be collected by members of the research team.
Intervention code [1] 328513 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care. This may include no ongoing allied health intervention inclusive of routinely delivered upper limb rehabilitation, delivered by an occupational therapist or physiotherapist. Mode and frequency of upper limb therapy within usual care will be dependent on usual procedures at that site.

The research team will collect data on duration, type of therapy and amount of repetitions completed during therapy sessions over the intervention period for both groups.
Control group
Active

Outcomes
Primary outcome [1] 338142 0
Change in upper limb motor impairment
Timepoint [1] 338142 0
Baseline (week 0), post-completion of intervention (week 5), follow up (week 17)
Secondary outcome [1] 434675 0
Grip Strength
Timepoint [1] 434675 0
Baseline (week 0), post intervention (week 5), follow up (week 17)
Secondary outcome [2] 434681 0
Afferent fibre density
Timepoint [2] 434681 0
Baseline (week 0), post-completion of intervention (week 5)
Secondary outcome [3] 434674 0
Change in upper limb dexterity
Timepoint [3] 434674 0
Baseline (week 0), post-completion of intervention (week 5), follow up (week 17)
Secondary outcome [4] 434678 0
Quality of life
Timepoint [4] 434678 0
Baseline (week 0), post-completion of intervention (week 5), follow up (week 17)
Secondary outcome [5] 434682 0
Acceptability of device
Timepoint [5] 434682 0
Post-completion of intervention (week 5)
Secondary outcome [6] 434679 0
Motor evoked potential
Timepoint [6] 434679 0
Baseline (week 0), post-completion of intervention (week 5)
Secondary outcome [7] 434676 0
Spasticity
Timepoint [7] 434676 0
Baseline (week 0), post-completion of intervention (week 5), follow up (week 17)
Secondary outcome [8] 446588 0
Usability of device
Timepoint [8] 446588 0
Post-completion of intervention (week 5)
Secondary outcome [9] 434677 0
Function in activities of daily living
Timepoint [9] 434677 0
Baseline (week 0), post- completion of intervention (week 5), follow up (week 17)
Secondary outcome [10] 434680 0
Resting motor threshold
Timepoint [10] 434680 0
Baseline (week 0), post-completion of intervention (week 5)

Eligibility
Key inclusion criteria
First diagnosis of stroke, confirmed by neuroimaging
Aged 18 years or over
Eligible for Transcranial Magnetic Stimulation (TMS)
Moderate to severe upper limb impairment as indicated by a Shoulder Abduction Finger Extension (SAFE) score of 2-7
Pre-morbid modified Rankin score of 3 or less
> 7 days and < 3 months post stroke onset
Short Portable Mental Status Questionnaire (SPMSQ) of > 5
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with contraindicators to magnetic resonance imaging (MRI)
People with absolute contraindicators to Transcranial Magnetic Stimulation (TMS)
Diagnosis of cerebellar stroke
Pre-morbid modified Rankin score of 4 or greater
Extremely severe upper limb impairment (SAFE score >7)
Mild upper limb impairment (SAFE score <2)
Short portable mental status questionnaire (SPMSQ) score of higher than 5
Unable to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised following baseline assessment using an automated randomisation table in REDCap. The randomisation schedule will be developed and uploaded into REDCap by a biostatistician otherwise independent of the study team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be stratified into two groups based in their Fugl-Meyer score - severe upper limb weakness group and mild to moderate upper limb weakness group
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
This is a pilot study and therefore no calculations were carried out to inform sample size.
Primary analysis will be conducted using a linear regression model with mean change in Fugl-Meyer Assessment score between baseline and post intervention as the dependent variable, study arm as the independent variable and baseline Fugl-Meyer values and time post stroke as covariates also used for co-variate adaptive minimisation.
Respective effects of all numerical secondary outcomes will be estimated using a mixed effect linear regression. This will also be used to investigate neural markers between the study arms, and changes over time on imaging.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
28/10/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26513 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 26512 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 42551 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 42552 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 316434 0
Charities/Societies/Foundations
Name [1] 316434 0
St Vincent's Curran Foundation
Country [1] 316434 0
Australia
Funding source category [2] 316407 0
Charities/Societies/Foundations
Name [2] 316407 0
St Vincent's Clinic Foundation
Country [2] 316407 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Health Network Sydney Limited
Address
Country
Australia
Secondary sponsor category [1] 318578 0
None
Name [1] 318578 0
Address [1] 318578 0
Country [1] 318578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315204 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315204 0
Ethics committee country [1] 315204 0
Australia
Date submitted for ethics approval [1] 315204 0
22/04/2024
Approval date [1] 315204 0
26/11/2024
Ethics approval number [1] 315204 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133970 0
Dr Lauren Christie
Address 133970 0
Level 4 Aikenhead building, St Vincent’s Hospital Sydney, 390 Victoria St Darlinghurst NSW 2010
Country 133970 0
Australia
Phone 133970 0
+61 436853797
Fax 133970 0
Email 133970 0
[email protected]
Contact person for public queries
Name 133971 0
Lauren Christie
Address 133971 0
Level 4 Aikenhead building, St Vincent’s Hospital Sydney, 390 Victoria St Darlinghurst NSW 2010
Country 133971 0
Australia
Phone 133971 0
+61 436853797
Fax 133971 0
Email 133971 0
[email protected]
Contact person for scientific queries
Name 133972 0
Lauren Christie
Address 133972 0
Level 4 Aikenhead building, St Vincent’s Hospital Sydney, 390 Victoria St Darlinghurst NSW 2010
Country 133972 0
Australia
Phone 133972 0
+61 436853797
Fax 133972 0
Email 133972 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.