Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001229561
Ethics application status
Approved
Date submitted
21/11/2022
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Two Types of Upper Limb Rehabilitation for Acute Stroke Patients
Scientific title
Effects of Computer-Based Upper Limb Therapy Using AbleX on arm function for Acute Stroke Patients: A Randomised Controlled Trial
Secondary ID [1] 308462 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute stroke 328266 0
Upper limb impairment 328268 0
Quality of life 328269 0
Condition category
Condition code
Stroke 325309 325309 0 0
Haemorrhagic
Stroke 325310 325310 0 0
Ischaemic
Physical Medicine / Rehabilitation 325311 325311 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be set-up by accredited Occupational Therapists (OTs) working within a regional public hospital and trained in standardisation of the intervention. Therapists will work with participants across both the acute stroke unit and subacute rehabilitation wards. Participants in the experimental group will receive 30 minutes of conventional therapist-facilitated task-specific practice for the upper limb as well as 30 minutes of individualised computer-based upper limb rehabilitation using the AbleX. The AbleX is a computer-based therapy tool that consists of games and activities accessed using a handheld controller or armskate for patients with more severe arm weakness. Therapists will engage in collaborative goal setting and functional task analysis to personalise specific rehabilitation routines for their patients based on the available activities and games within the AbleX computer-based program. An example of a game that may be undertaken as part of AbleX includes solitaire with the use of the AbleX handlebar to click, move and release cards appropriately on the computer screen. Therapists will also engage in collaborative goal setting and functional task analysis to set-up personalised conventional upper limb therapy routines as part of the conventional upper limb therapy completed. An example of an activity that may be undertaken as part of conventional task-specific practice includes patients using their affected upper limb to stack cones in order to improve arm coordination and strength. Once participants are appropriately set-up with their programs, these may be subsequently delegated to the Allied Health Assistants (AHA’s) and/or OT students. Both groups will perform their respective programs five days a week (Monday to Friday) via semi-supervised practice for the duration of their inpatient stay. Both 30 minute components can be completed within the same 1 hour period or separated and completed at any time of the day. Both groups will perform their respective programs for the duration of their inpatient stay or until their upper limb function is deemed to have plateaued by an OT. An audit of the participants medical record / chart will be undertaken fortnightly by an OT or research assistant to monitor adherence.
Intervention code [1] 324904 0
Rehabilitation
Comparator / control treatment
Participants in the control group will receive one hour of therapist-facilitated, repetitive, task-specific practice relevant to their upper limb goals. Therapists will also engage in collaborative goal setting and functional task analysis to set-up personalised conventional upper limb therapy routines as part of the conventional upper limb therapy completed. An example of an activity that may be undertaken as part of conventional task-specific practice includes patients using their affected upper limb to stack cones in order to improve arm coordination and strength. Participants may complete the one hour of upper limb therapy all together or complete it over two x 30 minute sessions completed at any time of the day. Both groups will perform their respective programs for the duration of their inpatient stay or until their upper limb function is deemed to have plateaued by an OT. An audit of the participants medical record / chart will be undertaken fortnightly by an OT or research assistant to monitor adherence.
Control group
Active

Outcomes
Primary outcome [1] 333174 0
Upper limb function. The primary outcome of the study will be any change in scores on the upper extremity subscale of the Fugl-Meyer Assessment of Motor Recovery after Stroke (UE-FMA).
Timepoint [1] 333174 0
At baseline and at the end of the participant’s inpatient stay.
Secondary outcome [1] 416052 0
Participant quality of life. Any change in participant quality of life assessed using the Stroke Impact Scale (SIS-16).
Timepoint [1] 416052 0
At baseline and at the end of the participant’s inpatient stay.
Secondary outcome [2] 416053 0
Amount of completed upper limb therapy repetitions. This outcome will be assessed through review of participant's medical record / chart.
Timepoint [2] 416053 0
At the end of the participant’s inpatient stay.
Secondary outcome [3] 416054 0
The amount of required direct therapist time. This outcome will be assessed through review of participant's medical record / chart.
Timepoint [3] 416054 0
At the end of the participant’s inpatient stay.

Eligibility
Key inclusion criteria
1) Diagnosis of acute stroke confirmed by magnetic resonance imaging and/or computed tomography brain scan received within less than three months
2) Mild-moderate upper limb motor impairment as determined by a score of 23-53 on the upper extremity subscale of the Fugl-Meyer Assessment of Motor Recovery after Stroke (UE-FMA) completed by an occupational therapist (OT)
3) Score of 24 or greater on the Mini-Mental State Examination indicating adequate cognition and communication for participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Comorbidities that contraindicate upper limb rehabilitation or exercise
2) Pre-existing/chronic upper limb impairment
3) Severe hemispatial neglect identified through completion of the Visual Perceptual Screen
4) Been given a palliative diagnosis

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 provided with a participant information sheet and consent form upon arrival to the acute stroke unit or subacute rehab ward by the Clinical Nurse Consultant (CNC) of the acute stroke unit or clinical nurse (CN) of the subacute rehabilitation ward. Group allocation will be provided to participants in a sealed envelope by the CNC, CN or OT.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants admitted to the acute stroke unit who provide informed consent will be randomised to either the experimental or control group via block randomisation to ensure equal numbers in both groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size estimate resulting in 34 required participants was made based off previous effect research in the use of virtual reality (VR) as an adjunct to improve upper limb (UL) function post stroke, most of which used a two-tailed a=0.05 and power of 0.8 to detect a small to medium effect size (Ahmad et al., 2019; El-Kafy et al., 2021; Hegazy et al., 2022; Hsu et al., 2019; Schuster-Amft et al., 2018; Wang et al., 2017). This study aims to recruit at least 41 participants to account for a potential dropout rate of 20%. The assessor’s past experience working within the acute stroke unit of Toowoomba Hospital and reviewing approximately two – four new stroke patients with UL weakness per week has also been utilised to ensure a feasible sample size has been selected.
SPSS Statistics will be used for statistical analysis. Independent t-test will be used to compare baseline patient demographic data. The level of statistical significance will be set at p = < .05. Data will be presented as mean ± standard deviation, with p values and confidence intervals reported for each outcome measure (change in UL function and change in participant quality of life) for both groups (intervention and control) between baseline and post-intervention. Between group differences at baseline and post-intervention will also be presented with p values and confidence intervals for each outcome measure. A paired t-test will be used to compare the changes between baseline and post-intervention results within each group for both outcomes. An independent t-test will be used to then compare the results between each group at baseline and post-intervention for both outcomes. Following this, effect sizes will be calculated using Cohen’s d for differences between baseline and post-intervention for both groups to determine the clinical significance of the results. Two independent t-tests will also be completed to compare completed UL repetitions and required direct therapist time between the intervention and control groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/07/2024
Date of last participant enrolment
Anticipated
2/07/2025
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
41
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23619 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 39038 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 312704 0
Charities/Societies/Foundations
Name [1] 312704 0
Toowoomba Hospital Foundation
Country [1] 312704 0
Australia
Primary sponsor type
Individual
Name
Georgia Parsons - OT Toowoomba Hospital Subacute Rehabilitation Ward
Address
Toowoomba Hospital, Pechey Street, Toowoomba 4350
Country
Australia
Secondary sponsor category [1] 314323 0
None
Name [1] 314323 0
Address [1] 314323 0
Country [1] 314323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312005 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 312005 0
Ethics committee country [1] 312005 0
Australia
Date submitted for ethics approval [1] 312005 0
16/05/2024
Approval date [1] 312005 0
20/05/2024
Ethics approval number [1] 312005 0

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

Contacts
Principal investigator
Name 123142 0
Ms Georgia Parsons
Address 123142 0
Toowoomba Hospital, Pechey Street, Toowoomba, Queensland 4350
Country 123142 0
Australia
Phone 123142 0
+617 4616 4327
Fax 123142 0
Email 123142 0
[email protected]
Contact person for public queries
Name 123143 0
Georgia Parsons
Address 123143 0
Toowoomba Hospital, Pechey Street, Toowoomba, Queensland 4350
Country 123143 0
Australia
Phone 123143 0
+617 4616 4327
Fax 123143 0
Email 123143 0
[email protected]
Contact person for scientific queries
Name 123144 0
Georgia Parsons
Address 123144 0
Toowoomba Hospital, Pechey Street, Toowoomba, Queensland 4350
Country 123144 0
Australia
Phone 123144 0
+617 4616 4327
Fax 123144 0
Email 123144 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
Data will not be shared or published with any stakeholders external to Queensland Health for confidentiality reasons.


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.