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Trial registered on ANZCTR


Registration number
ACTRN12619000146190
Ethics application status
Approved
Date submitted
25/01/2019
Date registered
31/01/2019
Date last updated
31/01/2019
Date data sharing statement initially provided
31/01/2019
Date results information initially provided
31/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Goal oriented instructions increase the number of repetitions completed in stroke rehabilitation: A within-participant, repeated measures experimental study
Scientific title
Goal oriented instructions increase the number of repetitions completed in stroke rehabilitation A within-participant, repeated measures experimental study
Secondary ID [1] 297214 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 311259 0
Condition category
Condition code
Stroke 309882 309882 0 0
Haemorrhagic
Stroke 309927 309927 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were be observed performing 25 repetitions of one of their usual exercises in the rehabilitation gym, under a non-specific instruction " do this exercise". The time taken to perform 25 repetitions was recorded. This formed the baseline measure. After a short rest, the participant was was presented with one of the following goal oriented instructions:
• A: “stand up and sit down 25 times”
• B: “stand up and sit down 25 times as fast as you can”
• C: “stand up and sit down 25 times as fast as you can, aim for your personal best!” The researcher provided additional encouragement whilst the participant performed the exercise such as “Go, Go, Go!”, “Over halfway there” and a countdown from 10 repetitions.

The time taken to perform 25 repetitions under each exercises was recorded using a stopwatch.
All participants received each of the three instructions over three days. The order the instructions were presented were block randomised. A new baseline measure was recorded each day.
Intervention code [1] 313465 0
Rehabilitation
Comparator / control treatment
The baseline measure, a non-specific instruction, was used as a comparator to determine the effect of each goal oriented instruction. The baseline measure acted as a control for each patient.
Control group
Active

Outcomes
Primary outcome [1] 318830 0
The number of repetitions completed per minute under each instruction. A stopwatch was used to time how long it took the participants to complete 25 repetitions under each instruction. A hand-held tally counter was used to count the number of repetitions. The results were converted into repetitions per minute.
Timepoint [1] 318830 0
Immediately post each instruction delivered.
Secondary outcome [1] 366195 0
Not applicable
Timepoint [1] 366195 0
Not applicable

Eligibility
Key inclusion criteria
greater than or equal to 18 years old; inpatients with an expected length of stay likely greater than one week or outpatients expected to attend at least five more therapy sessions
able to perform 50 repetitions of a lower limb exercise without physical assistance (e.g. sit to stand, tilt table strengthening exercises, stepping exercises)
sufficient English to understand simple instructions
adequate cognition to follow simple instructions.
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 did not require inpatient physiotherapy rehabilitation and/or were not medically stable to participate in rehabilitation exercises.

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)
Instruction orders were block randomised and sequentially allocated to participants as the were enrolled into the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All participants received each of the three instructions, the order they were presented in and the content of each instruction was blinding from the patient.
Due to the nature of the study, it was not possible to blind assessors as they presented the instruction and recorded the time taken to perform the exercise.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
All data analyses were performed using statistical software with the level of significance set at p<0.05. The mean difference and 95% confidence interval between baseline and each goal oriented instruction was calculated and the average percentage increase of repetition rate from baseline to each goal oriented instruction was calculated. Repeated measures of variance (ANOVA) was applied to the percentage change to ascertain statistically significant differences between the instructions. Bonferroni adjustment was used for multiple comparisons. As significance was found paired sample t-tests were used to compare the percentage change between each instruction (A vs B, A vs C, B vs C) to determine the most effective instruction.

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)
NSW
Recruitment hospital [1] 12992 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 25472 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 301767 0
University
Name [1] 301767 0
Australian Catholic Universtiy
Address [1] 301767 0
Australian Catholic University
Level 6, 33 Berry Street
North sydney, NSW
2060
Country [1] 301767 0
Australia
Primary sponsor type
Individual
Name
Tessa Hillig
Address
Australian Catholic University
Level 6, 33 Berry Street
North Sydney, NSW
2060
Country
Australia
Secondary sponsor category [1] 301532 0
Individual
Name [1] 301532 0
Simone Dorsch
Address [1] 301532 0
Level 6,
33 Berry Street
North Sydney, NSW 2060
Country [1] 301532 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302482 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 302482 0
Level 2, UNSW Clinical School
Liverpool Hospital,
Goulburn St
Liverpool, NSW 2170
Ethics committee country [1] 302482 0
Australia
Date submitted for ethics approval [1] 302482 0
07/06/2017
Approval date [1] 302482 0
14/07/2017
Ethics approval number [1] 302482 0
HREC/17/LPOOL/86

Summary
Brief summary
After stroke, there is strong evidence that indicates that the greater the intensity of practice in rehabilitation, the better the function outcome for the patient. Currently, there is no research that has determined the effect of instructions on increasing intensity of practice in rehabilitation. Therefore, the primary purpose of this study is to test three goal oriented instructions and compare them to a non-specific instruction. A non specific instruction, "do this exercise", was presented to a participant and the time taken to perform repetitions was recorded. Then, one of three goal oriented instructions were presented. These instructions are 1) “do [exercise] 25 times,”, 2) “do [exercise] 25 times as fast as you can and 3) “do [exercise] 25 times, as fast as you can, aiming for a personal best”, The time taken under each instruction was converted to repetitions per minute,
Each participant received all three instructions in a random order, with one instruction presented per day over three days.
For each instruction, the recorded time for twenty five repetitions was converted to a rate of repetitions/minute. The time taken to perform the twenty five repetitions under each goal oriented instruction was be compared with the non specific instruction and a percentage change in rate of repetitions was calculated. Statistical anaylsis was applied to determine if one instruction was more effective at increasing intensity of practice
Trial website
Not application
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 90370 0
Miss Tessa Hillig
Address 90370 0
Australian Catholic University
Level 6, 33 Berry Street, North Sydney
2060
Country 90370 0
Australia
Phone 90370 0
+61 423 084 409
Fax 90370 0
Email 90370 0
tessa.hillig@hotmail.com
Contact person for public queries
Name 90371 0
Dr Simone Dorsch
Address 90371 0
Australian Catholic University
Level 6, 33 Berry Street, North Sydney NSW 2060
PO Box 968
Country 90371 0
Australia
Phone 90371 0
+61 2 9739 2277
Fax 90371 0
Email 90371 0
simone.dorsch@acu.edu.au
Contact person for scientific queries
Name 90372 0
Dr Simone Dorsch
Address 90372 0
Australian Catholic University
Level 6, 33 Berry Street, North Sydney NSW 2060
PO Box 968
Country 90372 0
Australia
Phone 90372 0
+61 2 9739 2277
Fax 90372 0
Email 90372 0
simone.dorsch@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will remain confidential. A mean rate of repetitions for each instruction will be presented.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1170 0
Study protocol
Citation [1] 1170 0
Link [1] 1170 0
Email [1] 1170 0
Other [1] 1170 0
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
Research questions: 1. Can goal oriented instructions increase the intensity of practice achieved by stroke survivors during a therapy session? 2. Is one type of goal oriented instruction more effective at increasing the intensity of practice achieved by stroke survivors during a therapy session
Background: There is strong evidence to suggest that the greater the intensity of practice in rehabilitation after stroke, the greater the functional improvements. A large number of repetitions must be performed for functional change to occur. However current rehabilitation is limited by poor staffing, lack of equipment or time, which means that patients are not completing large doses of practice. Instructions are a cost effective, simple strategy that may be used to increase the amount of practice. This study is the first to analyze the effect of goal oriented instructions on intensity of practice in stroke rehabilitation.
Participant characteristics: . The mean age of the participants was 70±15 years with an average time after stroke of 70±182 days. 75% of participants scored a modified Rankin Scale of 4. This is considered of moderately severe disability
Key results: Participants increased their rate of repetitions by 62 to 128% under the goal oriented instructions. The most effective instruction was “do [exercise] 25 times as fast as you can, aim for your personal best!)
Limitations: change in movement quality was not objectively measured.