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Trial registered on ANZCTR


Registration number
ACTRN12618001271291
Ethics application status
Approved
Date submitted
24/07/2018
Date registered
27/07/2018
Date last updated
27/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation into sensory awareness practice (quality of movement) following stroke.
Scientific title
An investigation to explore if sensory awareness practice focusing on quality of movement improves body awareness, quality of life and function following stroke.

Secondary ID [1] 295489 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 308758 0
Condition category
Condition code
Stroke 307688 307688 0 0
Haemorrhagic
Stroke 307689 307689 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients following stroke will be involved in a sensory awareness program delivered by two specialised Physiotherapists. This will be provided in addition to usual care and routine therapy.
Participants will complete a movement series of ten specific lessons focusing on the quality of their movement by performing/sensing a range of small and easy movements (for example shifting weight from one side of the pelvis to the other or shifting one side of the hip forwards and backwards). Two separate classes of 45 minutes will be delivered in a group setting at a hall in a metropolitan area for 10 weeks (total of 20 sessions) on a Monday and Thursday morning. Participants will practice each of the lessons twice (the first lesson of each week will be new while the second a follow-up/repeat). An attendance roll will be used to monitor participant adherence to the program.
Intervention code [1] 301810 0
Rehabilitation
Intervention code [2] 301975 0
Treatment: Other
Comparator / control treatment
Patients following stroke will be given the same ten lessons in the form of an audiotape to complete as a home based program. Two classes of 45 minutes each will be given via audiotape at home for 10 weeks (total of 20 sessions). Again, participants will practice each of the lessons twice at least two days apart (the first lesson of each week will be new while the second a follow-up/repeat). Participant adherence to the program will be monitored by weekly phone calls and email contact.
Control group
Active

Outcomes
Primary outcome [1] 306675 0
Change in quality of life (SSEQ).
Timepoint [1] 306675 0
Baseline assessment on admission and post-intervention at 10 weeks.
Primary outcome [2] 306868 0
Change in quality of life (SIS).
Timepoint [2] 306868 0
Baseline assessment on admission and post-intervention at 10 weeks.
Primary outcome [3] 306885 0
Change in quality of life (SSQoL).
Timepoint [3] 306885 0
Baseline assessment on admission and post-intervention at 10 weeks.
Secondary outcome [1] 349202 0
Primary Outcome: Body awareness (BAQ).
Timepoint [1] 349202 0
*Primary timepoint: Baseline assessment on admission and post-intervention at 10 weeks.
Secondary outcome [2] 350020 0
*Primary Outcome: Body awareness (MAIA).
Timepoint [2] 350020 0
*Primary timepoint: Baseline assessment on admission and post-intervention at 10 weeks.
Secondary outcome [3] 350022 0
Change in function (FMA-UE/LL).
Timepoint [3] 350022 0
Baseline assessment on admission and post-intervention at 10 weeks.
Secondary outcome [4] 350023 0
Change in function (MAL).
Timepoint [4] 350023 0
Baseline assessment on admission and post-intervention at 10 weeks.
Secondary outcome [5] 350024 0
Change in function (10MWT).
Timepoint [5] 350024 0
Baseline assessment on admission and post-intervention at 10 weeks.
Secondary outcome [6] 350025 0
Change in function (EmNSA).
Timepoint [6] 350025 0
Baseline assessment on admission and post-intervention at 10 weeks.
Secondary outcome [7] 350026 0
Change in function (PSFS).
Timepoint [7] 350026 0
Baseline assessment on admission and post-intervention at 10 weeks.

Eligibility
Key inclusion criteria
Patients with a diagnosis of stroke (>3 months-6 years) and discharged from all intensive inpatient and outpatient rehabilitation programs.

An ability to provide informed consent or a guardian/family members approval to participate
in the study .

Patients with physical stroke-related impairment/s (i.e. weakness, sensation) and an ability to follow two step verbal instructions.

All ranges of stroke severity, ages, genders and past medical history.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients <3 months or >6 years following stroke.

Patients <18 years of age.

Patient, guardian and/or therapist refusal/inability to provide consent.

Participants with dysphasia or a language barrier.

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)
Allocation is concealed via a web based randomisation system. Once a participant consents to involvement in the study, the participant will be assessed. A block randomisation schedule (sealed envelope/spreadsheet) will be generated (using a computer generated randomisation schedule) and participants will then be randomly allocated by a third party to one of these two groups . All databases/spreadsheets will be secured by the use of passwords.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be performed using a secure web based computer generated randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There has been no research published in this area to date. A pilot study will be conducted to determine feasibility and effectiveness of a sensory awareness program using a total sample size of n=20 (considering a drop out of n=4).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
Date of last participant enrolment
Anticipated
15/08/2018
Actual
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 23302 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 300078 0
University
Name [1] 300078 0
University of South Australia- Ines Serrada
Country [1] 300078 0
Australia
Primary sponsor type
Individual
Name
Ines Serrada
Address
University of South Australia, School of Health Sciences CEA-14, GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 299476 0
Individual
Name [1] 299476 0
Susan Hillier
Address [1] 299476 0
University of South Australia, School of Health Sciences CEA-14, GPO Box 2471
Adelaide SA 5001
Country [1] 299476 0
Australia
Secondary sponsor category [2] 299595 0
Individual
Name [2] 299595 0
Brenton Hordacre
Address [2] 299595 0
University of South Australia, School of Health Sciences CEA-14, GPO Box 2471
Adelaide SA 5001
Country [2] 299595 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300923 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 300923 0
Ethics committee country [1] 300923 0
Australia
Date submitted for ethics approval [1] 300923 0
28/07/2015
Approval date [1] 300923 0
31/08/2015
Ethics approval number [1] 300923 0
HREC/15/RAH/328
Ethics committee name [2] 300925 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 300925 0
Ethics committee country [2] 300925 0
Australia
Date submitted for ethics approval [2] 300925 0
Approval date [2] 300925 0
Ethics approval number [2] 300925 0

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

Contacts
Principal investigator
Name 85294 0
Miss Ines Serrada
Address 85294 0
University of South Australia, School of Health Sciences CEA-14, GPO Box 2471
Adelaide SA 5001
Country 85294 0
Australia
Phone 85294 0
+61 0422378093
Fax 85294 0
Email 85294 0
ines.serrada@mymail.unisa.edu.au
Contact person for public queries
Name 85295 0
Ines Serrada
Address 85295 0
University of South Australia, School of Health Sciences CEA-14, GPO Box 2471
Adelaide SA 5001
Country 85295 0
Australia
Phone 85295 0
+61 0422378093
Fax 85295 0
Email 85295 0
ines.serrada@mymail.unisa.edu.au
Contact person for scientific queries
Name 85296 0
Ines Serrada
Address 85296 0
University of South Australia, School of Health Sciences CEA-14, GPO Box 2471
Adelaide SA 5001
Country 85296 0
Australia
Phone 85296 0
+61 0422378093
Fax 85296 0
Email 85296 0
ines.serrada@mymail.unisa.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.