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Trial registered on ANZCTR


Registration number
ACTRN12619001557123
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
12/11/2019
Date last updated
8/06/2021
Date data sharing statement initially provided
12/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the ELEMENTS tablet for post-stroke rehabilitation
Scientific title
Evaluation of the ELEMENTS tablet for rehabilitation of cognition and dexterity of the upper limb in post-stroke rehabilitation
Secondary ID [1] 299173 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 314282 0
Condition category
Condition code
Stroke 312631 312631 0 0
Haemorrhagic
Stroke 312632 312632 0 0
Ischaemic
Physical Medicine / Rehabilitation 312997 312997 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is comprised of two cohorts: (1) hospital or inpatient based rehabilitation patients and (2) community based rehabilitation patients.

Both cohorts will complete 30 min of individual therapy sessions (conventional or experimental), 3 times weekly, prescribed by a senior Occupational/Physical Therapist specialist. The inpatient cohort will complete the interventions for 4 weeks as an inpatient and then an additional 8 weeks once discharged into the community and will be supported by a Specialist Occupational/Physical Therapist if and when required. The community based cohort will complete 8 weeks of therapy only and participants allocated to this group will complete all the therapy sessions in their own homes.

For the experimental intervention we will use the ELEMENTS-T tablet, an electronic device containing a computer software providing a mix of goal-directed and exploratory upper-limb movement and cognitive interactive tasks. The software will provide exercises of moderate intensity. Adherence to the therapy program will be monitored and recorded online, participants will be contacted by phone if/when required. Participants will complete all therapy session in hospital (inpatient cohort) and later at home (Community based cohort).
For the conventional intervention we will use the Graded Repetitive Arm Supplementary Program (GRASP), an evidence based exercise program designed for Stroke patients at the University of British Columbia https://neurorehab.med.ubc.ca/grasp/. This program provides a moderately intensive level of exercises and focus on part practice of the upper limb addressing strength, dexterity and rang of motion.
Participants will keep track and evidence of adherence to this program on a table and will receive regular phone calls to assess and monitor adherence.

Both cohorts will receive initially a 30 minute education session from a Senior Therapist and will be expected to complete the prescribed tasks in a self directed manner thereafter if able. Those participants requiring assistance with set up will have access to this from a family member or therapist, however they will be expected to complete all tasks with little to no intervention from another.
Intervention code [1] 315480 0
Rehabilitation
Intervention code [2] 315701 0
Treatment: Devices
Intervention code [3] 315702 0
Treatment: Other
Comparator / control treatment
The control/comparator group will complete conventional treatment plus GRASP for the same dosage as the intervention group (3 times weekly 30 minutes exercise sessions).
Control group
Active

Outcomes
Primary outcome [1] 321289 0
Unilateral gross manual dexterity measured using the Box and Blocks Test (BBT)
Timepoint [1] 321289 0
Baseline
Post-treatment (Inpatient Assessments) at 4 weeks post commencement of interventions.
Post treatment (Community Based assessments) at 8 weeks post commencement of interventions.
3-months follow up assessment
Primary outcome [2] 321290 0
Cognitive functioning as measured by the Montreal Cognitive Assessment (MoCA)
Timepoint [2] 321290 0
Baseline
Post-treatment (Inpatient Assessments) at 4 weeks post commencement of interventions.
Post treatment (Community Based assessments) at 8 weeks post commencement of interventions.
3-months follow up assessment
Primary outcome [3] 321440 0
Stroke Impact Scale
Timepoint [3] 321440 0
Baseline
Post-treatment (Inpatient Assessments) at 4 weeks post commencement of interventions.
Post treatment (Community Based assessments) at 8 weeks post commencement of interventions.
3-months follow up assessment
Secondary outcome [1] 374537 0
Finger dexterity as measured by the 9-Hole Peg Test
Timepoint [1] 374537 0
Baseline
Post-treatment (Inpatient Assessments) at 4 weeks post commencement of interventions.
Post treatment (Community Based assessments) at 8 weeks post commencement of interventions.
3-months follow up assessment
Secondary outcome [2] 374538 0
CogState Computerised Brief Battery
Timepoint [2] 374538 0
Baseline
Post-treatment (Inpatient Assessments) at 4 weeks post commencement of interventions.
Post treatment (Community Based assessments) at 8 weeks post commencement of interventions.
3-months follow up assessment
Secondary outcome [3] 374949 0
Degree of disability as measured by the Modified Rankin Scale (mRS)
Timepoint [3] 374949 0
Baseline
Post-treatment (Inpatient Assessments) at 4 weeks post commencement of interventions.
Post treatment (Community Based assessments) at 8 weeks post commencement of interventions.
3-months follow up assessment
Secondary outcome [4] 374950 0
Neurobehavioural Function Inventory (NFI)
Timepoint [4] 374950 0
Baseline
Post-treatment (Inpatient Assessments) at 4 weeks post commencement of interventions.
Post treatment (Community Based assessments) at 8 weeks post commencement of interventions.
3-months follow up assessment
Secondary outcome [5] 374951 0
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)
Timepoint [5] 374951 0
Baseline
Post-treatment (Inpatient Assessments) at 4 weeks post commencement of interventions.
Post treatment (Community Based assessments) at 8 weeks post commencement of interventions.
3-months follow up assessment

Eligibility
Key inclusion criteria
1. Aged 18 years and above
2. English speaking
3. Sustained an ischemic or haemorrhagic stroke, subsequently confirmed on routine
neuroimaging
4. Admitted to the Rehabilitation Service of the Hospital (or respective hospital)
for treatment of identified upper limb rehabilitation needs
5. Able to provide informed consent
6. At least partial active anti-gravity upper limb movement at shoulder, elbow and forearm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous history of neurologic or psychiatric disorder
2. Pre-existent dementia (standardised cut-off of at least 3.6 on the short Informant Questionnaire on Cognitive Decline in the Elderly
3. Receptive aphasia preventing comprehension of instructions
4. Visual acuity deficit that prevents perception of visual material
5. Lack of a contact telephone to arrange follow-up

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed-effects Analysis of Variance (ANOVA) will be used to compare the outcomes of participants (Conventional Treatment Group vs. Combined Treatment Group) at each time point (baseline, post-inpatient intervention/post-outpatient intervention, and 3-month follow-up). Correlation and hierarchical regression analyses will be used to identify and determine the impact of moderator/predictor variables on motor, cognitive, and functional outcomes. Finally, the effect sizes of primary and secondary outcome measures and 95% confidence intervals will be calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/11/2019
Actual
25/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14719 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 27759 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 303716 0
Commercial sector/Industry
Name [1] 303716 0
AusIndustry
Country [1] 303716 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade, Fitzroy Vic 3065
Country
Australia
Secondary sponsor category [1] 303830 0
University
Name [1] 303830 0
University of Sydney
Address [1] 303830 0
The University of Sydney
Camperdown NSW 2050
Australia
Country [1] 303830 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304241 0
South Eastern Sydney Local Health District - Human Research Ethics Committee
Ethics committee address [1] 304241 0
Room G71 East Wing,
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 304241 0
Australia
Date submitted for ethics approval [1] 304241 0
Approval date [1] 304241 0
05/03/2019
Ethics approval number [1] 304241 0

Summary
Brief summary
We anticipate that participants recovering from stroke will be able to participate in inpatient and home-based ELEMENTS-T therapy effectively and will show enhanced motivation to engage in therapy as a result of their involvement. This will fulfil the principle that rehabilitation methods that encourage intense interaction are most beneficial. With the ELEMENTS-T system, intensity is ‘given for free’ because the therapy is fun and the benefits accrue incidentally as a function of active and playful interaction. We expect that the user interaction afforded by the system will enable inpatients to make significant gains in motor and cognitive function, compared to treatment as usual.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96250 0
Dr Jeffrey Rogers
Address 96250 0
The University of Sydney
Camperdown NSW 2050
Country 96250 0
Australia
Phone 96250 0
+61 2 9351 9261
Fax 96250 0
Email 96250 0
[email protected]
Contact person for public queries
Name 96251 0
Jeffrey Rogers
Address 96251 0
The University of Sydney
Camperdown NSW 2050
Country 96251 0
Australia
Phone 96251 0
+61 2 9351 9261
Fax 96251 0
Email 96251 0
[email protected]
Contact person for scientific queries
Name 96252 0
Jeffrey Rogers
Address 96252 0
The University of Sydney
Camperdown NSW 2050
Country 96252 0
Australia
Phone 96252 0
+61 2 9351 9261
Fax 96252 0
Email 96252 0
[email protected]

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?

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
SourceTitleYear of PublicationDOI
EmbaseHome-based (virtual) rehabilitation improves motor and cognitive function for stroke patients: a randomized controlled trial of the Elements (EDNA-22) system.2021https://dx.doi.org/10.1186/s12984-021-00956-7
N.B. These documents automatically identified may not have been verified by the study sponsor.