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
ACTRN12617000168358
Ethics application status
Approved
Date submitted
18/01/2017
Date registered
1/02/2017
Date last updated
16/10/2019
Date data sharing statement initially provided
16/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A telehealth transfer package to improve post stroke rehabilitation outcomes.
Scientific title
Translational neurorehabilitation - Efficacy of a telehealth transfer package for improving upper-limb function post-stroke.
Secondary ID [1] 288538 0
Nil known
Universal Trial Number (UTN)
U1111-1179-6689
Trial acronym
TTP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 297638 0
Upper-limb impairment 297639 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297830 297830 0 0
Other physical medicine / rehabilitation
Stroke 301441 301441 0 0
Ischaemic
Stroke 301442 301442 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To compare the functional outcomes of providing a telehealth transfer package to post stroke patients enrolled in an 8 week Outpatient/Day patient upper-limb therapy program with those receiving usual care alone. Group 1 will receive the transfer package for the 2nd and 3rd week (2 weeks) of their Outpatient/Day patient program. The transfer package will be delivered via individual (one-on-one) face-to-face sessions 1x per week after the patients formal therapy visit and via individual (one-on-one) telehealth sessions 4x per week. All sessions will occur on weekdays and be approximately 30-minutes long in duration. They will then have 1 additional face-to face session each week for the following 4 weeks. The transfer package includes: a behavioural contract where the patient and applicant will decide which activities the patient will complete with their more-affected hand. This will be reviewed each day by the therapist and patient during their session and amended accordingly; a daily motor activity log; a daily activity diary, a daily schedule of home practice prescribed by the treating therapists and a list of optional motor-function specific supplementary activities the patient can complete at their leisure. Goal setting and problem solving will also be discussed at each setting and will reiterate practice from formal therapy sessions. The telehealth component will be delivered via Skype on the patient’s usual household computer. Patients will be given clear instructions on how to download and use Skype. The intervention will be delivered by an Accredited Exercise Physiologist who has a PhD in upper-limb rehabilitation after stroke. The therapist will monitor adherence with daily sessions and they will keep a log the completed transfer package for each day. Group 2 will receive their usual 8 week Outpatient/Day patient program,
Intervention code [1] 293916 0
Rehabilitation
Intervention code [2] 296942 0
Treatment: Other
Comparator / control treatment
The control group will receive their usual 8 week outpatient occupational program. They will not receive the additional telehealth transfer package.
Control group
Active

Outcomes
Primary outcome [1] 297358 0
Physical function assessed using the Fugl-Meyer Assessment
Timepoint [1] 297358 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will then be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Primary outcome [2] 297359 0
Movement speed will be assessed using the Wolf Motor Function Test timed tasks
Timepoint [2] 297359 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Primary outcome [3] 297360 0
the Motor Activity Log Quality of Movement Scale will be used as an index of transfer of therapy induced gains to activities of daily living.
Timepoint [3] 297360 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Secondary outcome [1] 320799 0
Strength will be assessed using the Wolf Motor Function Test strength based tasks
Timepoint [1] 320799 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Secondary outcome [2] 320800 0
Gross manual dexterity will be assessed with the Box and Block Test
Timepoint [2] 320800 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Secondary outcome [3] 320801 0
Fine manual dexterity will be assessed with the Grooved Pegboard
Timepoint [3] 320801 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Secondary outcome [4] 320802 0
Depression, Anxiety, Stress Scale (DASS21)
Timepoint [4] 320802 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Secondary outcome [5] 320807 0
Stroke Impact Scale
Timepoint [5] 320807 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Secondary outcome [6] 320808 0
Fatigue Severity Scale
Timepoint [6] 320808 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Secondary outcome [7] 320809 0
Pain rating (Visual Analogue Score)
Timepoint [7] 320809 0
Patients from both groups will be assessed at 4 time points. Baseline function will be assessed during week 1 of their outpatient program. For those in the intervention group, the transfer package will run for Week 2 and 3, All patients will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program). Finally all patients will be assessed at 6 months to investigate maintenance.
Secondary outcome [8] 320810 0
Satisfaction will be assessed with a 10 point visual analogue scale with 10 being most satisfied.
Timepoint [8] 320810 0
Satisfaction will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program).
Secondary outcome [9] 330989 0
Self rated improvement will be assessed with a 10 point visual analogue scale with 10 being the greatest imaginable improvement.
Timepoint [9] 330989 0
Self rated improvement will be assessed at Week 4 (post transfer package intervention) and at Week 8 (post 8 week outpatient program).

Eligibility
Key inclusion criteria
INCLUSION CRITERIA
Stroke patients receiving an Outpatient or Day patient rehabilitation program will be recruited from St Vincent’s Hospital’s Sacred Heart Allied Health Services. Inclusion criteria are: >18 years of age, ischaemic or haemorrhagic stroke with an upper limb deficit, cognitively competent with a MMSE >24, able to communicate in English and participating in an Outpatient/Day patient program to improve upper-limb function (i.e. Occupational Therapy).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
EXCLUSION CRITERIA
Exclusion criteria are: patients participating in other upper-limb rehabilitation research trials during the 8 week program period, blindness, deafness, no carer for those with low function and poor balance and no internet or computer access.

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)
Randomisation will be achieved using a computer-generated schedule created using randomly permeating blocks. A St Vincent’s Hospital staff member who will not take part in assessment or therapy delivery will conceal the allocations in numbered opaque envelopes prior to study commencement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
This is a single centre pilot randomised controlled trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic data will be presented as mean and standard error, medians and interquartile range and/or percentages where appropriate. One Way Anovas, Wilcoxon Signed Rank Tests and Chi square analysis will be used for normal, abnormal and categorical data respectively. Mixed Model Repeated Measures Anovas will be used to compare the difference between groups. Significance will be taken at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5273 0
Sacred Heart Hospice - Darlinghurst

Funding & Sponsors
Funding source category [1] 292890 0
Other
Name [1] 292890 0
AMR Translational Research Grant, St Vincent's Centre of Applied Medical Research
Country [1] 292890 0
Australia
Primary sponsor type
Other
Name
St Vincent's Centre of Applied Medical Research
Address
405 Liverpool Street, Sydney, NSW, 2011
Country
Australia
Secondary sponsor category [1] 291632 0
None
Name [1] 291632 0
None
Address [1] 291632 0
None
Country [1] 291632 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294389 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 294389 0
390 Victoria Street, Darlinghurst, NSW, 2010
Ethics committee country [1] 294389 0
Australia
Date submitted for ethics approval [1] 294389 0
23/11/2015
Approval date [1] 294389 0
14/01/2016
Ethics approval number [1] 294389 0
HREC/15/SVH/430

Summary
Brief summary
In Australia there are currently >425,000 people living with a stroke related disability and this number is only set to rise with the aging population and burgeoning epidemics of diabetes and obesity. In the chronic post-stroke period the only way to improve function and independence is through rehabilitation. Constraint-Induced Movement Therapy (CIMT) is the current best practice for upper-limb rehabilitation. Recent evidence suggests that CIMT's success may be due to one component, the transfer package which encourages patients to be more responsible for their own recovery. The package includes daily revision of a behavioural contract, Motor Activity Log (an index of how well the patient can complete everyday activities with their more-affected hand), daily activity diary, daily schedule (including home practice), and patient-centred goal setting and problem solving. Preliminary research also suggests that this package can be transferred to other intensive therapies with equal benefits. However, such intensive programs are rarely used in routine clinical practice due to lack of staff and resources. This study aims to investigate the use of the transfer package delivered via telehealth in current hospital outpatient rehabiltation programs. I hypothesise that patients receiving the transfer package will have greater improvements in function and will not require recurrent outpatient programs thus reducing costs and improving the capacity of the outpatient hospital system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63538 0
A/Prof Steven Faux
Address 63538 0
Lv 2 Sacred Heart Buidling,
St Vincent's Hospital,
170 Darlinghurst Road,
Darlinghurst, NSW, 2010
Country 63538 0
Australia
Phone 63538 0
+61283829516
Fax 63538 0
Email 63538 0
[email protected]
Contact person for public queries
Name 63539 0
Dr Angelica Thompson Butel
Address 63539 0
School of Exercise Science
Australian Catholic University
Lv2 Edward Clancy Building
163-167 Albert Road
Strathfield, NSW, 2135
Country 63539 0
Australia
Phone 63539 0
+61422908875
Fax 63539 0
Email 63539 0
[email protected]
Contact person for scientific queries
Name 63540 0
Dr Angelica Thompson Butel
Address 63540 0
School of Exercise Science
Australian Catholic University
Lv2 Edward Clancy Building
163-167 Albert Road
Strathfield, NSW, 2135
Country 63540 0
Australia
Phone 63540 0
+61422908875
Fax 63540 0
Email 63540 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
The research team needs confirmation from the ethics department on sharing for this particular research study. If approved the data will be shared.


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.