Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001724460
Ethics application status
Approved
Date submitted
13/12/2016
Date registered
16/12/2016
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Tele-rehabilitation for the arm after stroke.
Scientific title
A tele-rehabilitation program for the upper limb after stroke.
Secondary ID [1] 290752 0
None
Universal Trial Number (UTN)
U1111-1190-9286
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 301342 0
Condition category
Condition code
Stroke 301113 301113 0 0
Haemorrhagic
Stroke 301114 301114 0 0
Ischaemic
Physical Medicine / Rehabilitation 301115 301115 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chronic stroke survivors will be given in-home based tele-rehabilitation to actively exercise the affected upper limb for one hour, 5 days per week for 8 weeks using inexpensive, commercially available devices (AbleX or AbleM, ImAble Ltd NZ), These will enable participants to play computer games that encourage arm use.. The program will be supervised over the internet by an experienced occupational therapist who will control the level of difficulty of the games and progress them as required..
Intervention code [1] 296657 0
Rehabilitation
Intervention code [2] 296675 0
Treatment: Devices
Comparator / control treatment
A commercially available on-line cognitive training program, Fit Brains, will be the active control intervention. Participants will undertake training for one hour, 5 days per week for 8 weeks. They will be supervised by an experienced occupational therapist who will monitor their progress on-line.
Control group
Active

Outcomes
Primary outcome [1] 300508 0
Arm Function, assessed using the Action Research Arm Test
Timepoint [1] 300508 0
8 weeks
Secondary outcome [1] 330157 0
Hand grip force using a Jamar dynamometer
Timepoint [1] 330157 0
8 weeks
Secondary outcome [2] 330158 0
Pinch force using a Jamar pinch dynamometer
Timepoint [2] 330158 0
8 weeks
Secondary outcome [3] 330159 0
Cognitive Function using the Trail Making Test
Timepoint [3] 330159 0
8 weeks
Secondary outcome [4] 330160 0
Montreal Cognitive Assessment
Timepoint [4] 330160 0
8 weeks
Secondary outcome [5] 330161 0
Community Integration Measure
Timepoint [5] 330161 0
8 weeks
Secondary outcome [6] 330162 0
Modified Caregiver Strain Index
Timepoint [6] 330162 0
8 weeks
Secondary outcome [7] 330202 0
Quality of Life using the EQ-5D-5L
Timepoint [7] 330202 0
8 weeks
Secondary outcome [8] 330203 0
Health Utilities Index Mark III
Timepoint [8] 330203 0
8 weeks

Eligibility
Key inclusion criteria
­1. Impaired function of the affected upper limb
2. Unilateral hemiparesis resulting from stroke affecting only one side (haemorrhage or infarct) at least 6 months prior to enrolment (lesion confirmed by CT or MRI where possible)
­3. Level of cognitive function within normal limits (score above 8) on the Abbreviated Mental Test Score
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe cognitive deficits
2. Severe receptive aphasia
3. Uncontrolled epilepsy
4. Serious progressive illness
5. Currently receiving any type of formal upper limb therapy.

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)
Central randomisation by off-site adminstrator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, with stratification by level of impairment (severe vs moderate or mild) and chronicity (6-12 months post-stroke vs >12 months post-stroke).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
The primary outcome will be analysed using a mixed-effect multilevel linear regression model with the change in Action Research Arm Test (ARAT) score following an intervention as the dependent variable, the nature of the intervention (tele-rehabilitation vs active control) as the independent variable, baseline ARAT score, impairment level and chronicity as covariates, and patient as a random effect (level) variable.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
19/12/2016
Actual
19/12/2016
Date of last participant enrolment
Anticipated
Actual
20/09/2017
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7131 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 14892 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 295178 0
Hospital
Name [1] 295178 0
Royal Melbourne Hospital
Country [1] 295178 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan Street
Parkville, VIC 3050
Country
Australia
Secondary sponsor category [1] 294007 0
None
Name [1] 294007 0
Address [1] 294007 0
Country [1] 294007 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296527 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 296527 0
c/- Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Ethics committee country [1] 296527 0
Australia
Date submitted for ethics approval [1] 296527 0
25/07/2016
Approval date [1] 296527 0
30/08/2016
Ethics approval number [1] 296527 0
HREC/16/MH/236

Summary
Brief summary
Stroke is a major cause of disability worldwide, with 5 million people left permanently disabled. In Australia, total lifetime cost burden of first-ever stroke was estimated to be more than A$2 billion. A large contribution of these costs result from out-of-pocket expenses, informal care, and productivity losses associated with stroke. Loss of upper limb function contributes significantly to stroke-related disability and reduced independence. Functional recovery of the paretic upper limb after stroke continues to be one of the greatest challenges faced by rehabilitation staff. Yet despite a wealth of research showing that recovery of function is driven by repetitive task-specific training, rehabilitation of the arm and hand is given lower priority than retraining of walking. The major barriers include limited rehabilitation resources, difficulties with travel to rehabilitation facilities, and, for more severely impaired patients, the need for external assistance or guidance.
We now propose to conduct a randomised controlled trial of in-home based tele-rehabilitation to actively exercise the affected upper limb in chronic stroke survivors using inexpensive, commercially available devices that enable participants to play computer games that encourage arm use and that can be progressed in level of difficulty. An on-line cognitive training program will be the active control intervention. We have previously shown that use of such devices in a centre-based program leads to improved arm function and quality of life. A parallel cost-effectiveness study will be conducted. If this intervention is found to be effective and cost-effective, it could be readily implemented as a practical, inexpensive, and motivating program of upper limb rehabilitation for stroke survivors in their own homes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71170 0
Prof Mary Galea
Address 71170 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville VIC 3010
Country 71170 0
Australia
Phone 71170 0
+61 3 8387 2017
Fax 71170 0
Email 71170 0
[email protected]
Contact person for public queries
Name 71171 0
Prof Mary Galea
Address 71171 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville VIC 3010
Country 71171 0
Australia
Phone 71171 0
+61 3 8387 2017
Fax 71171 0
Email 71171 0
[email protected]
Contact person for scientific queries
Name 71172 0
Prof Mary Galea
Address 71172 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville VIC 3010
Country 71172 0
Australia
Phone 71172 0
+61 3 8387 2017
Fax 71172 0
Email 71172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
No additional documents have been identified.