Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001677897p
Ethics application status
Submitted, not yet approved
Date submitted
19/10/2021
Date registered
8/12/2021
Date last updated
8/12/2021
Date data sharing statement initially provided
8/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the acceptability of an intensive, multidisciplinary mobility program for community stroke survivors.
Scientific title
The feasibility of a short duration, intensive, multidisciplinary, self-managed mobility program for community stroke survivors
Secondary ID [1] 305588 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Stroke
 324006 0
Condition category
Condition code
Stroke 321515 321515 0 0
Haemorrhagic
Stroke 321731 321731 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will determine the feasibility of a revised intensive (45 hours over 3 weeks, with a follow up period in 3 weeks) therapy program developed to improve mobility for community dwelling stroke survivors. The program is offered as a mix of semi supervised, group practice and individual practice with groups of 3 participants. The sessions run for 60 minutes, three times per day for five consecutive days for three weeks (a total of 15 hours of therapy time allocated). The embedded self management program is the 'Taking Charge After Stroke' Program developed by Dr Harry McNaughton and used with his approval, to improve adherence and acceptability of the program. The multidisciplinary team will be a mix of physiotherapy, exercise physiology and occupational therapy delivering task specific, strength, mobility and cardiorespiratory training. For example, sit to stand practice, tilt table training or body weight support mobility training over ground or on a treadmill. The intervention will have a standard structure but will be provided on an 'intention to treat' basis, and training will be individualised according to the participant's performance on assessment and their identified therapy goals. The intervention will be delivered in two private community rehabilitation sites across Sydney, however participants may elect to complete ~10% of the training at home via a home exercise program. Adherence to the program will be recorded in a participant workbook on practice sheets. If participants are unable to complete active exercise training, they will be given the option to complete mental practice or action observation practice in the allocated time. Intensity of the level of training will be recorded two ways, via number of repetitions (aiming for a personal best each session) and Borg RPE (13-16 on 20 point scale).
Intervention code [1] 321985 0
Rehabilitation
Comparator / control treatment
No control group, it will be a prospective single group pre and post intervention study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329282 0
Feasibility: Adherence
This will be measured by each participant in a workbook and extracted from the participant's rehabilitation centre files. It will taken as a percentage of sessions attended and number of repetitions completed per session.
Timepoint [1] 329282 0
At the end of the intervention (Week 3).
Primary outcome [2] 329283 0
Feasibility: Acceptability

This will be measured two ways:
Extracting perceived exertion (Borg Rating) from practice sheets from participants files at the study site (First measure).
Timepoint [2] 329283 0
Borg rating will be taken at mid point (Week2 of intervention) and at the end of the intervention (Week 3)
Primary outcome [3] 329284 0
Feasibility: Safety

Measured by number of incidences occurred during intervention. An incidence is defined as any adverse outcome for participants, staff or organisation. The physiotherapist will record any in clinic incidents in a incident log and participants will record any incidents occurring outside the clinic and related to the intervention in their participant workbook.
Timepoint [3] 329284 0
Taken at Week 3 directly after the intervention.
Secondary outcome [1] 402013 0
Mobility (Measured two ways- see below)
Measured by performance in Short Physical Performance Battery (SPPB), 2 Minute Walk Test (2MWT) (First Mobility outcome)
Timepoint [1] 402013 0
SPPB and 2MWT measures will be taken at Week 0, Week 2 (mid way through the intervention), Week 3 (at the end of the intervention) and Week 6 ( 3 weeks post the intervention completed).
Secondary outcome [2] 402014 0
Quality of life

Quality of life will be measured by the responses of participants to the Short Form Survey (SF-12)
Timepoint [2] 402014 0
Responses will be taken at Week 0, Week 3 (end of intervention) and Week 6 ( 3 weeks post intervention completion)
Secondary outcome [3] 402015 0
Self-Efficacy

Self Efficacy will be measured using the Exercise Self Efficacy Scale (ESES)
Timepoint [3] 402015 0
The ESES will be taken at Week 0, Week 3 (end of intervention) and Week 6 ( 3 weeks post intervention completion)
Secondary outcome [4] 402016 0
Goal attainment

Goal Attainment will be measured by the Goal Attainment Scale (GAS)
Timepoint [4] 402016 0
GAS will be taken at Week 0, Week 3 (end of intervention) and Week 6 ( 3 weeks post intervention completion)
Secondary outcome [5] 402017 0
Primary Outcome: Feasibility: Cost

Cost will be reported on as a reflection of % of standard clinic fees
Timepoint [5] 402017 0
Week 6 ( 3 weeks post intervention)
Secondary outcome [6] 402783 0
Primary outcome: Feasibility: Acceptability (2nd measure)

Via a purpose built paper survey
Timepoint [6] 402783 0
The Acceptability survey will be taken at the end of the intervention (Week 3) and at 3 weeks follow up (Week 6)
Secondary outcome [7] 402784 0
Mobility:
Motor Assessment Scale for Stroke (MAS) (Second Mobility outcome)
Timepoint [7] 402784 0
MAS will be taken at Week 0, Week 3 (post intervention) and Week6 ( 3 weeks post intervention completed).

Eligibility
Key inclusion criteria
Eligibility criteria:
Clients can participate in the program if:
• They are over 18 years of age
• Physical or Medical readiness to participate using the Physical Activity Readiness Questionnaire (PARQ)
• They have sufficient mobility: They achieve 3 or more in the sitting component and 2 or more in the sitting to standing component of the Motor Assessment Scale for Stroke (MAS)

Inclusion Criteria:
Participants will be included in the research study if:
• They have nominated to participate in an intensive mobility program at the study site and meet the sites criteria as listed above
• Have a primary diagnosis of stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the research study:
• They cannot read or understand verbal or written English
• Do not have sufficient cognition to participate in a video guided or semi-supervised exercise program (as determined by their score on a Mini Mental State Examination (MMSE) > 24/30)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size is likely to be 15 persons determined by recruitment to the study from the two research sites.

Demographic data will be reported via descriptive statistics. Adherence data will be calculated from each week and from week 0 (T1) to week 3 (T2) and will be reported as mean repetitions per hour, session, and week and then as a percentage of overall sessions attended. Acceptability and self-management data will be taken from the surveys and will be reported as frequencies comparing time points week 3 (T3) and week 6 (T4). Acceptability data from the practice sheets use will be calculated from each week and from week 0 (T1) to week 3 (T3) and will be reported as mean values per week and then as a percentage overall. Paired t-tests will be used to analyse within group change over time for the clinical outcomes between week 0 (T1) to week 3 (T3) and between week 0 (T1) to week 6 (T4). Differences will be reported as a mean and 95% confidence interval.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/12/2021
Actual
Date of last participant enrolment
Anticipated
10/01/2022
Actual
Date of last data collection
Anticipated
30/04/2022
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 35620 0
2134 - Burwood
Recruitment postcode(s) [2] 35621 0
2153 - Bella Vista

Funding & Sponsors
Funding source category [1] 309953 0
University
Name [1] 309953 0
Macquarie University
Country [1] 309953 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
75 Talavera Road
Macquarie University 2109 NSW
Country
Australia
Secondary sponsor category [1] 310996 0
None
Name [1] 310996 0
None
Address [1] 310996 0
Country [1] 310996 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309668 0
Macquarie University Human Research Ethics Committee (HREC)
Ethics committee address [1] 309668 0
Ethics committee country [1] 309668 0
Australia
Date submitted for ethics approval [1] 309668 0
20/10/2021
Approval date [1] 309668 0
Ethics approval number [1] 309668 0

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

Contacts
Principal investigator
Name 114970 0
Dr Katharine Scrivener
Address 114970 0
Ground Floor, 75 Talavera Road, Macquarie University NSW 2109
Country 114970 0
Australia
Phone 114970 0
+61 2 9850 6625
Fax 114970 0
Email 114970 0
[email protected]
Contact person for public queries
Name 114971 0
Avanthi Elisha Ball
Address 114971 0
Concentric Rehabilitation Centre Burwood
Suite 4, 1-17 Elsie Street Burwood, NSW 2134
Country 114971 0
Australia
Phone 114971 0
+61 2 7226 5850
Fax 114971 0
Email 114971 0
[email protected]
Contact person for scientific queries
Name 114972 0
Avanthi Elisha Ball
Address 114972 0
Concentric Rehabilitation Centre Burwood
Suite 4, 1-17 Elsie Street Burwood, NSW 2134
Country 114972 0
Australia
Phone 114972 0
+61 2 7226 5850
Fax 114972 0
Email 114972 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
Only group data will be available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13638Study protocol    382978-(Uploaded-19-10-2021-12-47-38)-Study-related document.pdf



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.