Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001564741
Ethics application status
Approved
Date submitted
4/12/2022
Date registered
19/12/2022
Date last updated
5/04/2024
Date data sharing statement initially provided
19/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of hybrid-technology upper limb rehabilitation for people with neurological impairments in hospital.
Scientific title
Feasibility of hybrid-technology enabled upper limb rehabilitation and impact on function in people with neurological impairments during inpatient rehabilitation in hospital.
Secondary ID [1] 308546 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper limb impairment from neurological disorder 328397 0
Condition category
Condition code
Stroke 325421 325421 0 0
Haemorrhagic
Stroke 325422 325422 0 0
Ischaemic
Neurological 325423 325423 0 0
Multiple sclerosis
Neurological 325424 325424 0 0
Parkinson's disease
Neurological 325425 325425 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RCT feasibility study with comparison of dose-matched upper limb therapy using a combination of robotics, virtual reality and sensor-based therapy (referred to as hybrid technology-enabled upper limb therapy) with usual care versus usual care alone.

Robotics will be used for distal hand retraining using Tyromotion Amadeo and / or elbow and shoulder retraining using Tyromotion Diego based on individual patient upper limb impairment. Upper limb retraining using virtual reality may involve use of immersive virtual reality using Tyromotion Diego and Occulus Rift googles or non-immersive virtual reality using Nintendo Wii. Sensor-based therapy may include a range of devices including Tyromotion Pablo, E-Link or AbleX devices with capability of sensor placement across all areas of the upper limb (fingers, hand, wrist, forearm or upper arm) or through linked response of device haptic end point (e.g. AbleX controller) with the therapeutic game software. All participants will be orientated to each device prior to use including set-up requirements, how they interact with therapeutic games / session and the related therapeutic purpose. While fitted with each device, participants may be asked to complete a set of passive or active movements, or to participate in a game requiring specific upper limb movements. Therapy progress information will be available to participants both within session and across session to session.

Hybrid technology-enabled upper limb therapy will be delivered by occupational therapists, clinical assistants and occupational therapy students in face to face individual or within a group therapy program (up to 4 per group) in a rehabilitation inpatient hospital setting. Preferred treatment delivery will be in a group format however patient factors (such as noise tolerance, concentration span, fatigue), infection control factors or staff resource factors may require a need for individual treatment delivery and will be determined on a day-by-day basis. The intervention will be delivered 1 hour x 2 daily x 5 days per week from rehabilitation admission to hospital discharge. As such, the maximum duration of therapy will vary across participants. Participant session attendance, therapy time, therapy engagement and devices used will be collected per session.
Intervention code [1] 324991 0
Rehabilitation
Intervention code [2] 325104 0
Treatment: Devices
Comparator / control treatment
The control group will include usual care that is dose-matched and delivered within individual or group therapy setting. Usual care includes a range and combination of rehabilitation activities such as range of motion exercises (passive and / or active), strength building (e.g., weighted / resistance tasks), reach-grasp-release practice (e.g., ball, cup, pen, cutlery), task-specific practice (e.g., pouring, cutting, writing) and practice of daily activities (e.g. self-feeding).

Usual care upper limb therapy will be delivered by occupational therapists, clinical assistants and occupational therapy students face to face for individual or group therapy (up to 6 per group) in a rehabilitation inpatient hospital setting. Preferred treatment delivery will be in a group format however patient factors (such as noise tolerance, concentration span, fatigue), infection control factors or staff resource factors may require a need for individual treatment delivery and will be determined on a day-by-day basis. The intervention will be delivered 1 hour x 2 daily x 5 days per week from rehabilitation admission to hospital discharge. As such, the maximum duration of therapy will vary across participants. Control group participant session attendance, therapy time, therapy engagement and content of therapy session will be collected per session.

The primary investigator will monitor feasibility factors and fidelity including demographic data, recruitment data and attendance rates across the study.
Control group
Active

Outcomes
Primary outcome [1] 333283 0
Patient self-reported outcome measure of arm function using Arm Activity Measure (Arm-A).
Timepoint [1] 333283 0
Baseline and inpatient discharge.
Primary outcome [2] 333284 0
Upper limb impairment measure using Fugl-Meyer Assessment-Upper Extremity.
Timepoint [2] 333284 0
Baseline and inpatient discharge.
Primary outcome [3] 333285 0
Upper limb activity measure using Action Research Arm Test.
Timepoint [3] 333285 0
Baseline and inpatient discharge.
Secondary outcome [1] 416465 0
Participation outcome measure using Community Integration Questionnaire-Revised. (Primary outcome).
Timepoint [1] 416465 0
Baseline and inpatient discharge.
Secondary outcome [2] 416466 0
Feasibility outcome addressing intervention acceptability using survey designed specifically for this study.
Timepoint [2] 416466 0
At inpatient discharge.
Secondary outcome [3] 416467 0
Feasibility outcome addressing therapy engagement using Pittsburgh Participation Rating Scale.
Timepoint [3] 416467 0
At each upper limb therapy group session.
Secondary outcome [4] 416468 0
Feasibility outcome addressing implementation via attendance rates using study data collection form for therapy attendance.
Timepoint [4] 416468 0
At each upper limb therapy group session.
Secondary outcome [5] 416469 0
Feasibility outcome addressing implementation via therapy intensity (time, repetitions) using
study data collection form for therapy dosage.
Timepoint [5] 416469 0
At each upper limb therapy group session.
Secondary outcome [6] 416698 0
Feasibility outcome addressing intervention efficacy through goal attainment and quality of life (EQ-5D-5L).
Timepoint [6] 416698 0
At inpatient discharge

Eligibility
Key inclusion criteria
Rehabilitation inpatients with neurological upper limb impairment caused by stroke (first or recurrent), traumatic or other acquired brain injury, spinal cord injury or other stable neurological condition with sufficient English to provide informed consent and cognitive function to follow instructions during group therapy sessions and the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Admitted rehabilitation inpatients with the following will be excluded - motor neuron disease or other deteriorating neurological conditions, patients in post-traumatic amnesia, patients with upper limb disorders from congenital conditions and people with upper limb amputations.

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)
Allocation schedule will be concealed in a password protected document held by an independent senior member of the research team who is off-site to the study and revealed upon enrollment for each participant following confirmation of patient consent by the primary investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization for allocation to the control or intervention groups will occur via computer generated using blocks of six to ensure balanced groups
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
The plan for statistical analysis includes: descriptive statistics to summarize findings of the feasibility outcome domains, screening of demographic data on upper limb outcomes, ANOVA analysis (mixed 2x2 ANOVAs) to compare outcome measures with groups as the between-subjects variables and time as the within-subjects variable and effect size calculated to enable a power analysis to inform future need and sample size for full-scale randomized-controlled trial. Qualitative analysis of survey outcomes of patient perspectives of feasibility parameters will also be conducted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/01/2023
Actual
17/01/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
30
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23671 0
Surgical Treatment and Rehabilitation Service (STARS) - Herston
Recruitment postcode(s) [1] 39102 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 312794 0
Hospital
Name [1] 312794 0
Surgical Treatment and Rehabilitation Service
Country [1] 312794 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Health Rehabilitation Sciences
Sir Fred Schonell Drive
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 314428 0
Hospital
Name [1] 314428 0
Surgical Treatment and Rehabilitation Service
Address [1] 314428 0
296 Herston Road
Herston QLD 4029
Country [1] 314428 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312081 0
Royal Brisbane & Women's Hospital (RBWH) HREC
Ethics committee address [1] 312081 0
Ethics committee country [1] 312081 0
Australia
Date submitted for ethics approval [1] 312081 0
23/07/2021
Approval date [1] 312081 0
27/07/2021
Ethics approval number [1] 312081 0
HREC/2020/QRBW/67076

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

Contacts
Principal investigator
Name 123402 0
Ms Giovanna Tornatore
Address 123402 0
The University of Queensland
St Lucia QLD 4072
Australia
Country 123402 0
Australia
Phone 123402 0
+61 736476815
Fax 123402 0
Email 123402 0
[email protected]
Contact person for public queries
Name 123403 0
Giovanna Tornatore
Address 123403 0
The University of Queensland
School of Health Rehabilitation Sciences
Sir Fred Schonell Drive
St Lucia QLD 4072
Country 123403 0
Australia
Phone 123403 0
+61 736478111
Fax 123403 0
Email 123403 0
[email protected]
Contact person for scientific queries
Name 123404 0
Hannah Gullo
Address 123404 0
The University of Queensland
School of Health Rehabilitation Sciences
Sir Fred Schonell Drive
St Lucia QLD 4072
Country 123404 0
Australia
Phone 123404 0
+61 733653004
Fax 123404 0
Email 123404 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
Individual patient data will be aggregated for publication purposes.


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.