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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 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

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]

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]

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]

Immediately post each instruction delivered.

Secondary outcome [1]

Not applicable

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

14/08/2017

Date of last participant enrolment

Anticipated

Actual

15/10/2018

Date of last data collection

Anticipated

Actual

26/10/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment postcode(s) [1]

2200 - Bankstown

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic Universtiy

Address [1]

Australian Catholic University
Level 6, 33 Berry Street
North sydney, NSW
2060

Country [1]

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]

Individual

Name [1]

Simone Dorsch

Address [1]

Level 6,
33 Berry Street
North Sydney, NSW 2060

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Level 2, UNSW Clinical School
Liverpool Hospital,
Goulburn St 
Liverpool, NSW 2170

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/06/2017

Approval date [1]

14/07/2017

Ethics approval number [1]

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

Miss Tessa Hillig

Address

Australian Catholic University
Level 6, 33 Berry Street, North Sydney
2060

Country

Australia

Phone

+61 423 084 409

Fax

tessa.hillig@hotmail.com

Contact person for public queries

Name

Simone Dorsch

Address

Australian Catholic University
Level 6, 33 Berry Street, North Sydney NSW 2060
PO Box 968

Country

Australia

Phone

+61 2 9739 2277

Fax

simone.dorsch@acu.edu.au

Contact person for scientific queries

Name

Simone Dorsch

Address

Australian Catholic University
Level 6, 33 Berry Street, North Sydney NSW 2060
PO Box 968

Country

Australia

Phone

+61 2 9739 2277

Fax

simone.dorsch@acu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1170	Study protocol					376828-(Uploaded-25-01-2019-17-32-19)-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.

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