Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000611426p
Ethics application status
Submitted, not yet approved
Date submitted
11/04/2016
Date registered
10/05/2016
Date last updated
10/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-care retraining following Stroke
Scientific title
The effectiveness of high intensity self-care retraining during inpatient rehabilitation following stroke: A pilot randomised controlled trial.
Secondary ID [1] 288658 0
Nil Known
Universal Trial Number (UTN)
U1111-1180-1852
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 297842 0
Personal Activities of Daily Living 297843 0
Condition category
Condition code
Stroke 298018 298018 0 0
Haemorrhagic
Stroke 298482 298482 0 0
Ischaemic
Physical Medicine / Rehabilitation 298483 298483 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research is a pilot randomised trial which aims to determine the effectiveness of intensive self-care retraining in sub-acute stroke rehabilitation.

Self-care retraining will be conducted 5 times per week for 2 weeks by an Occupational Therapist or Occupational Therapy Allied Health Assistant with inpatients in a rehabilitation unit who have suffered a stroke and are having difficulty with showering and dressing,

Intervention will be personalised to provide remediation of difficulties identified within assessment. Level of intensity will be as prescribed for all in each group. The intervention will be delivered individually face to face. Each session will take as long as each individual requires based on their particular difficulties. On average a self-care retraining session takes between 40-60 minutes to be depicted in its entirety.

Adherence will be monitored by recording of session completion logs. Where a session is unable to be conducted this will be recorded along with the primary reason for the session non-completion.
Intervention code [1] 294072 0
Rehabilitation
Comparator / control treatment
The control group will receive the usual care of the inpatient rehabilitation unit. This currently comprises targeted self-care retraining conducted up to twice per week by an Occupational Therapist or occupational therapy Allied Health Assistant.
Control group
Active

Outcomes
Primary outcome [1] 297532 0
Composite Primary Outcome - Between group difference mean (95% CI) on the ability of participants to shower and dress - measured using Stage 1 of Perceive, Recall, Plan, Perform (PRPP) System of Task Analysis .
Timepoint [1] 297532 0
Baseline, post-intervention (2 weeks)
Secondary outcome [1] 321340 0
Functional Independence Measure score
Timepoint [1] 321340 0
Baseline, post-intervention (2 weeks)
Secondary outcome [2] 321341 0
Measurement of feasibility
Safety through recording of adverse events such as injurious falls, non-injurious falls, and/or fatigue.
Timepoint [2] 321341 0
post-intervention (2 weeks)
Secondary outcome [3] 322795 0
Measurement of feasibility
Trial recruitment through calculation of the number of patients screened, eligible and enrolled.
Timepoint [3] 322795 0
post recruitment of last subject
Secondary outcome [4] 322796 0
Feasibility of intervention measured through time taken to administer the intervention to all enrolled participants.
Timepoint [4] 322796 0
post study completion
Secondary outcome [5] 322797 0
Feasibility of intervention measured through patient compliance with the intervention. This will be assessed by proportion of intervention sessions completed.
Timepoint [5] 322797 0
post study completion
Secondary outcome [6] 322798 0
Feasibility of intervention measured through patient acceptability through responses on a acceptability survey designed for use in this study only.
Timepoint [6] 322798 0
post intervention (2 weeks)

Eligibility
Key inclusion criteria
-People receiving rehabilitation following stroke in an inpatient rehabilitation unit
-Functional Independence Measure (FIM) score of less than 5 in bathing and dressing–upper and dressing-lower tasks
-Sufficient communication and cognition to follow instructions and participate in rehabilitation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion from the study will include a pre-stroke score of less than 5 in bathing and dressing–upper and dressing-lower tasks FIM tasks, indicating pre-existing difficulties which may be due to a cognitive or physical disability.
Any barriers to taking part in a physical rehab program.

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 sequence will be pre-generated and concealed in numbered, opaque envelopes. The therapist recruiting participants will not be involved.

Following enrollment into the study participants will be assigned to a study group via this pre-determined sequence which will be managed by a staff member external to the study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer software generated randomisation sequence. Random permuted blocks will be used so that both groups contain equal numbers
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
Clinical outcomes will be appraised using mean, standard deviations and 95% confidence intervals, and t-tests will compare between group data. Feasibility outcomes and baseline characteristics will be evaluated using proportions, means and standard deviations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2016
Actual
Date of last participant enrolment
Anticipated
30/09/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 5365 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 12818 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 293016 0
Hospital
Name [1] 293016 0
The Canberra Hospital
Country [1] 293016 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
Rehabilitation, Aged and Community Care
Canberra Hospital and Health Service
PO Box 11
Woden, ACT 2606
Country
Australia
Secondary sponsor category [1] 291792 0
University
Name [1] 291792 0
Flinders University
Address [1] 291792 0
Flinders University
Sturt Rd,
Bedford Park SA 5042
Country [1] 291792 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294526 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 294526 0
Ethics committee country [1] 294526 0
Australia
Date submitted for ethics approval [1] 294526 0
24/03/2016
Approval date [1] 294526 0
Ethics approval number [1] 294526 0

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

Contacts
Principal investigator
Name 62206 0
Ms Michelle Bennett
Address 62206 0
Team Leader Community Based Rehabilitation and Aged Care Services,
Rehabilitation, Aged and Community Care
12A
Canberra Hospital and Health Service
PO Box 11
Woden ACT 2606
Country 62206 0
Australia
Phone 62206 0
+61 403 127 056
Fax 62206 0
Email 62206 0
[email protected]
Contact person for public queries
Name 62207 0
Michelle Bennett
Address 62207 0
Team Leader Community Based Rehabilitation and Aged Care Services,
Rehabilitation, Aged and Community Care
12A
Canberra Hospital and Health Service
PO Box 11
Woden ACT 2606
Country 62207 0
Australia
Phone 62207 0
+61 403 127 056
Fax 62207 0
Email 62207 0
[email protected]
Contact person for scientific queries
Name 62208 0
Michelle Bennett
Address 62208 0
Team Leader Community Based Rehabilitation and Aged Care Services,
Rehabilitation, Aged and Community Care
12A
Canberra Hospital and Health Service
PO Box 11
Woden ACT 2606
Country 62208 0
Australia
Phone 62208 0
+61 403 127 056
Fax 62208 0
Email 62208 0
[email protected]

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.