Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000427673
Ethics application status
Approved
Date submitted
14/03/2014
Date registered
17/04/2014
Date last updated
10/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of INteractive Digital Technology (FIND) Technology
Scientific title
A randomised controlled trial on the feasibility and effect on physical activity and functional mobility of the additional use of Interactive Digital Technology compared to usual care in stroke survivors undergoing rehabilitation
Secondary ID [1] 284256 0
nil
Universal Trial Number (UTN)
Trial acronym
FIND Technology
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 291377 0
Condition category
Condition code
Neurological 291739 291739 0 0
Other neurological disorders
Cardiovascular 291926 291926 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be participation in interactive computer based activities using the kinect system and software designed for stroke rehabilitation for up to 50 minutes up to 5 times per week during inpatient rehabilitation stay (2-8 weeks). Sessions will be supervised by a physiotherapist or occupational therapist, and attendance recorded. The software records duration and activities particpated in. This will be in addition to usual care 1;1 treatment on the ward by the ward physiotherapist
Intervention code [1] 288963 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control condition will recieve usual care 1;1 treatment on the ward by the ward physiotherapist and participate in a circuit style physical activity program that currently runs on the ward, so that the two groups will be matched for activity level.
Control group
Active

Outcomes
Primary outcome [1] 291674 0
Feasability will be determined using a suite of scales for enjoyment, pain, fatigue, exertion and benefit
1. PAES
2. VAS pain
3. VAS fatigue
4. RPE (borg)
5. Perceived benefit scale
Timepoint [1] 291674 0
Monitored on a daily basis throughout the 8 week duration of therapy. as well at the end of the trial the SUS (System Usability Scale) will be administered
Primary outcome [2] 291675 0
Activity using an actipal accelerometer worn on the thigh for one week
Timepoint [2] 291675 0
one week at the start of therapy
Secondary outcome [1] 307293 0
Improved Physical functioning using a suite of tests;
1. upper limb function using the MAS and box and block test
2. balance using sitting balance test, functional reach (in sitting if required), lateral reach, postural sway and step test
3. mobility using timed up and go and 10 meter walk
Timepoint [1] 307293 0
at discharge from in-patient trial

Eligibility
Key inclusion criteria
Inpatients on the Rehabiliation ward at the local hospital

Stroke<6 months ago
Reduced mobility
Clinician assessed capacity to improve
Life expectancy >12 months
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment (for example MMSE,21)
Insufficient English
Medical condition precluding exercise (eg unstable cardiac disease, uncontrolled metabolic disease or weight bearing restriction)
Receptive Aphasia

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)
All patients admitted to the rehabilitation ward a during the trial period will be screened for inclusion by a senior neurological physiotherapist. Eligible patients will be given information about the project and if they are interested, a research assistant (physiotherapist) will be contacted to provide further information. Written consent will be obtained before participation in the project. A physiotherapist or occupational therapist from another ward will perform the pre- testing before randomisation and in post testing will not be provided with information regarding group allocation. Group allocation will be concealed using consecutively-numbered opaque envelopes, opened after completion of assessment in the presence of the participant
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation into intervention or control group will occur using a computer-generated random number schedule with variable block sizes. Generation of the randomization sequence will be generated by a researcher not involved in recruitment or assessment. Group allocation will be concealed using consecutively-numbered opaque envelopes, opened after completion of assessment in the presence of the participant.
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
Safety/efficacy
Statistical methods / analysis
Feasability will be described using qualitative methods and report on the outcome measures of enjoyment, perceived benefit, fatigue and exertion and system usability.
For the outcome measures of activity and the functional measures collected during the RCT we will describe the participants’ changes in balance and mobility using t-tests or Mann-Whitney U tests to compare normally and non-normally distributed data respectively. Repeated measures analysis of variance (ANOVA) will be used to compare changes over time and between group changes in data for the outcome measures. The level of significance will be set at 0.05.

A previous Pilot study on feasibility for technology in stroke rehabilitation has used a sample size of 40 participants (Bower, ANZCTR). Data for sub-acute stroke population is available for Forward Functional Reach Test mean (SD) data 25.6 (7.4)cm from Outermans (2010). A clinically relevant difference of 3.7cm would require a sample size of 63 (p less than 0.05, power 80%). 74 will be recruited to allow for a 15% drop out rate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2014
Actual
4/11/2014
Date of last participant enrolment
Anticipated
30/07/2016
Actual
21/07/2016
Date of last data collection
Anticipated
Actual
5/08/2016
Sample size
Target
74
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 2189 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 7867 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 288892 0
Charities/Societies/Foundations
Name [1] 288892 0
The Stroke Foundation, Australia
Country [1] 288892 0
Australia
Primary sponsor type
University
Name
The University of Tasmania
Address
The School of Health Science,
Locked Bag 1320,
Launceston, 7250
TASMANIA
Country
Australia
Secondary sponsor category [1] 287589 0
None
Name [1] 287589 0
Address [1] 287589 0
Country [1] 287589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290724 0
Tasmanian Health and Medical Research Ethics Committee
Ethics committee address [1] 290724 0
Ethics committee country [1] 290724 0
Australia
Date submitted for ethics approval [1] 290724 0
Approval date [1] 290724 0
27/02/2014
Ethics approval number [1] 290724 0
H0013769

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

Contacts
Principal investigator
Name 46910 0
Dr Marie-Louise Bird
Address 46910 0
The School of Health Science
University of Tasmania
Locked Bag 1320
Launceston 7250
Country 46910 0
Australia
Phone 46910 0
+61 3 63245497
Fax 46910 0
Email 46910 0
birdm@utas.edu.au
Contact person for public queries
Name 46911 0
Marie-Louise Bird
Address 46911 0
The School of Health Science
University of Tasmania
Locked Bag 1320
Launceston 7250
Country 46911 0
Australia
Phone 46911 0
+61 3 63245497
Fax 46911 0
Email 46911 0
birdm@utas.edu.au
Contact person for scientific queries
Name 46912 0
Marie-Louise Bird
Address 46912 0
The School of Health Science
University of Tasmania
Locked Bag 1320
Launceston 7250
Country 46912 0
Australia
Phone 46912 0
+61 3 63245497
Fax 46912 0
Email 46912 0
birdm@utas.edu.au

No information has been provided regarding IPD availability


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.