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Trial registered on ANZCTR


Registration number
ACTRN12620000252910
Ethics application status
Approved
Date submitted
17/02/2020
Date registered
26/02/2020
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Date results information initially provided
26/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the addition of concurrent visual feedback increase adherence to a home exercise program in people with stroke: a single-case series?
Scientific title
Does the addition of concurrent visual feedback increase adherence to an upper limb home exercise program in people with stroke: a single-case series?
Secondary ID [1] 300579 0
Nil known
Universal Trial Number (UTN)
U1111-1248-4535
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 316314 0
physical inactivity 316315 0
Condition category
Condition code
Neurological 314581 314581 0 0
Other neurological disorders
Stroke 314659 314659 0 0
Ischaemic
Stroke 314660 314660 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 314661 314661 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the intervention phase (weeks 2 and 3), participants were provided with a tablet computer (Apple model A1474) and were instructed by a physiotherapist in how to use the device. Participants were asked to video record each exercise session, using the MoviePro App, a videorecording app that was downloaded onto the tablet computer for a small fee paid by the research project. This required participants to tap on a single mobile application, pressing a Record button at the start and end of each session. The tablet computer was set up in front of the participant so that they were able to see themselves exercising and they were instructed to look at the screen as they exercised. Participants were instructed to perform upper limb exercises 6 days per week for 60 minutes at their individual capacity. Participants kept a record of the duration of exercise on a recording sheet. Exercises were prescribed from the Graded Repetitive Arm Supplementary Program (GRASP). The GRASP program contains exercises for the whole arm (including stretches) and the elbow and hand (for example, pouring water from a cup, folding clothes, using putty) The program continued for 4 weeks.
Intervention code [1] 316883 0
Rehabilitation
Intervention code [2] 316944 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322908 0
Time spent exercising as measured via accelerometry
Timepoint [1] 322908 0
Recorded daily for 4 weeks duration
Secondary outcome [1] 380215 0
Usability of the tablet computer was assessed with the System Usability Scale
Timepoint [1] 380215 0
At study completion (4 weeks)

Eligibility
Key inclusion criteria
Criteria for inclusion were diagnosis of stroke (>3 months), completion of formal rehabilitation and being able to pick up a small block with the stroke-affected hand.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they were less than 18 years old, had a Mini-Mental State Examination score (MMSE) of less than 24 out of 30,were non-English speaking (or absence of an English-speaking carer) or had a visual deficit preventing technology use.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Active wear time data were analysed using the two standard deviation (2 SD) band method which has been recommended for the analysis of single-case series designs

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15913 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 29370 0
5042 - Bedford Park
Recruitment postcode(s) [2] 29371 0
5042 - Flinders University

Funding & Sponsors
Funding source category [1] 305000 0
Hospital
Name [1] 305000 0
Flinders Medical Centre
Address [1] 305000 0
Flinders Drive
Bedford Park, South Australia
5042
Country [1] 305000 0
Australia
Primary sponsor type
Individual
Name
Tamina Levy
Address
Flinders Medical Centre - Rehabilitation and Palliative Services
Flinders Drive
Bedford Park, South Australia
5042
Country
Australia
Secondary sponsor category [1] 305354 0
None
Name [1] 305354 0
N/A
Address [1] 305354 0
N/A
Country [1] 305354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305397 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC EC00188).
Ethics committee address [1] 305397 0
Ward 6c, Room CA219
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Ethics committee country [1] 305397 0
Australia
Date submitted for ethics approval [1] 305397 0
07/05/2018
Approval date [1] 305397 0
13/07/2018
Ethics approval number [1] 305397 0
217.17

Summary
Brief summary
The primary aim of this study was to determine if the addition of concurrent visual feedback, via a tablet computer, would increase adherence to an upper limb home exercise program in people with stroke.
A secondary aim was to assess the feasibility of use of upper limb accelerometry as a method of monitoring upper limb activity during a home exercise program in people with stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100238 0
Dr Maggie Killington
Address 100238 0
Flinders University
Sturt Road
Bedford Park 5042
South Australia
Country 100238 0
Australia
Phone 100238 0
+61 0882751103
Fax 100238 0
Email 100238 0
maggie.killington@fliders.edu.au
Contact person for public queries
Name 100239 0
Mrs Tamina Levy
Address 100239 0
Flinders Medical Centre - Rehabilitation Services
Flinders Drive
Bedford Park
SA 5042
Country 100239 0
Australia
Phone 100239 0
+61 0409282210
Fax 100239 0
Email 100239 0
tamina.levy@sa.gov.au
Contact person for scientific queries
Name 100240 0
Mrs Tamina Levy
Address 100240 0
Flinders Medical Centre - Rehabilitation Services
Flinders Drive
Bedford Park
SA 5042
Country 100240 0
Australia
Phone 100240 0
+61 0409282210
Fax 100240 0
Email 100240 0
tamina.levy@sa.gov.au

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
AIM 1: to determine if the addition of concurrent visual feedback, via a tablet computer, will increase adherence to an upper limb home exercise program in people with stroke

Overall, a significant effect was observed in 4 out of the 10 cases (participants 1, 5, 7, 10), meaning that these participants performed a significantly greater amount of exercise when they were using the tablet computer to provide feedback.
Furthermore, one participant (participant 9) showed a statistically significant reduction in performance at follow-up when the tablet computer was removed.
Nine participants reported that they enjoyed the tablet computer and found it beneficial in terms of giving feedback and improving engagement.


AIM 2: to assess the feasibility of use of upper limb accelerometry as a method of monitoring upper limb activity

Accelerometry acceptability was measured via the System Usability Scale. The mean score for the System Usability Scale was 96.5 out of 100, indicating a high level of usability.
The accelerometer devices provided objective data representing exercise times. However, there were several problems in terms of data collection. Issues that arose included missing data (participants 4, 9, 10); despite reportedly charging the devices, data were missing during the last three days of exercise in Participants 4 and 9. One device malfunctioned during the final week for Participant 10. Two participants forgot to put devices on and/or off (participants 2 and 5), on one occasion for each participant. A further two participants forgot to charge the accelerometers (participants 1 and 7), and participant 7 had no recorded data after day 15. Two participants were unable to put the device on the non-affected wrist without assistance (participants 4 and 6).
There were no issues with accelerometry utility or data collection in participants 3 and 8.