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Trial registered on ANZCTR


Registration number
ACTRN12616001288415
Ethics application status
Approved
Date submitted
1/09/2016
Date registered
13/09/2016
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Repetitive Exercise for People after Stroke (REPS): a pilot randomised controlled trial
Scientific title
Repetitive Exercise for People after Stroke (REPS): effects on functional performance.
Secondary ID [1] 290053 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 300106 0
Stroke - Haemorrhagic and Ischaemic 300107 0
Condition category
Condition code
Neurological 299989 299989 0 0
Other neurological disorders
Injuries and Accidents 300054 300054 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the experimental group will receive usual care (see Usual care) and a 2-week package of exercises and strategies that will provide them with additional opportunities to practice a functional task*.

This package will include a range of strategies* individualised to the needs of the participant for increasing the amount of practice of a functional task. Participants will be required to perform as many repetitions of this task as they can per day.

*Details of functional tasks and strategies used to increase repetitive practice have been omitted to minimise contamination between groups.

Intervention code [1] 295806 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group will receive usual care (see Usual care),

Usual care
Usual care for both groups will consist of two one-hour sessions of physiotherapy a day and will include one-to-one or group therapy with a physiotherapist. This therapy will involve strength, endurance, balance and coordination exercises as well as task-specific practice of sitting, sitting-to-standing, standing, and walking. All exercises will be tailored to the needs of each participant.
Control group
Active

Outcomes
Primary outcome [1] 299471 0
Clinicians’ impression of functional change over two weeks

A video recording of a participant performing a functional task* will be taken at baseline and again at two weeks. A Global Impression of Change (GIoC) scale will be used to rate the functional change of a participant. The GIoC scale is a 15-point scale with -7 representing ‘very much worse’, 0 representing ‘no difference’, and +7 representing ‘very much better’. A mean between-group difference of 2/15 points is considered clinically important.

*Details of functional tasks have been omitted to minimise contamination between groups.
Timepoint [1] 299471 0
Baseline and at 14 days (Two weeks)
Secondary outcome [1] 327285 0
Sit-to-Stand (STS) ability

STS ability will be assessed using the STS item of the Mobility Scale for Acute Stroke Patients (MSAS). This item will be rated on a 6-point scale based on level of assistance required to complete the task of STS with a score of 1 denoting inability to complete the task and a score of 6 denoting completion of the task unassisted and safely.
Timepoint [1] 327285 0
Baseline and at 14 days (Two weeks)
Secondary outcome [2] 327286 0
Composite strength of the key muscles of the affected lower limb

The strength of the hip extensors, knee extensors, and plantar flexors will be assessed using manual muscle testing. Scores for the three muscle groups will be combined and treated as a composite measure of lower limb extensor strength, with 15 points representing the maximum score.
Timepoint [2] 327286 0
Baseline and at 14 days (Two weeks)
Secondary outcome [3] 327287 0
Gross lower limb extension strength

Gross lower limb extension strength will be measured using an inclinometer on a sliding tilt table. A participant will be transferred to a sliding tilt table and positioned with only their affected lower limb on the foot plate and knee placed in 60deg flexion. The tilt table will be raised and the participant will be instructed to extend their lower limb. The highest degree of incline against which the participant can extend their lower limb will be recorded.
Timepoint [3] 327287 0
Baseline and at 14 days (Two weeks)
Secondary outcome [4] 327288 0
The Goal Attainment Scale (GAS)

Prior to baseline assessments, participants will identify one personal goal related to a functional task* in conjunction with a physiotherapist. The goal will be set according to the SMART principle, that is, the goal will be specific, measurable, attainable, realistic and timely. A blinded assessor will rate attainment of the goal at the 2-week assessment. The goal will be rated on a 5-point scale, where “0” denotes the expected level of achievement; “+1” and “+2” are respectively “a little” and “a lot” better than expected, whilst “-1” and “-2” are correspondingly “a little” and “a lot” less than expected. A higher score will reflect better achievement of goals than a lower score.

*Details of functional tasks have been omitted to minimise contamination between groups.
Timepoint [4] 327288 0
Baseline and at 14 days (Two weeks)
Secondary outcome [5] 327370 0
Ranking of change in participants' ability to perform a functional task*

A blinded assessor will rank each of the 30 participants in order from most improved to least improved. The assessor will use the videos collected as part of the primary outcome to determine participants’ ranking.

*Details of functional tasks have been omitted to minimise contamination between groups.
Timepoint [5] 327370 0
Baseline and at 14 days (Two weeks)

Eligibility
Key inclusion criteria
Diagnosis of a first time stroke or any other acquired brain injury (ABI) that is not progressive
Acute event < 6 months before the study onset
Sufficient communication skills to indicate yes/no verbally or via gestures
Sufficient cognition to consent or consent will be obtained from the person responsible
Stroke/ABI has affected the ability to STS
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Limited joint range of movement or musculoskeletal conditions that would prevent participation
Inability to participate in exercise i.e. Medically unwell
Unable to follow instructions
Expected length of stay of < 2 weeks

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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

Funding & Sponsors
Funding source category [1] 294421 0
Hospital
Name [1] 294421 0
Graythwaite Rehabilitation Centre
Address [1] 294421 0
Graythwaite Rehabilitation Centre
Ryde Hospital
Denistone Road
Eastwood
NSW 2122
Country [1] 294421 0
Australia
Primary sponsor type
Individual
Name
Davide de Sousa
Address
Graythwaite Rehabilitation Centre
Ryde Hospital
Denistone Road
Eastwood
NSW 2122
Country
Australia
Secondary sponsor category [1] 293271 0
Individual
Name [1] 293271 0
Prof. Lisa Harvey
Address [1] 293271 0
John Walsh Centre For Rehabilitation Research
Kolling Institute
Northern Sydney Local Health District
Royal North Shore Hospital
St Leonards
NSW 2065
Country [1] 293271 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295846 0
Northern Sydney Coast Human Research Ethics Committee
Ethics committee address [1] 295846 0
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 295846 0
Australia
Date submitted for ethics approval [1] 295846 0
27/07/2016
Approval date [1] 295846 0
12/08/2016
Ethics approval number [1] 295846 0
HREC/16/HAWKE/252

Summary
Brief summary
Following acquired brain injury (ABI) caused by stroke or trauma many people cannot move around independently due to motor impairments such as weakness and poor coordination. These people require intensive repetitive practice to improve their ability to move around. Therefore the aim of this study is to determine if a two-week intensive package of functional training improves functional performance more than usual care in people with ABI admitted to a sub-acute ward for rehabilitation.

Experimental design:
An assessor blinded randomised controlled trial will be conducted. Each participant will be randomly allocated to an experimental or control group using the principles of concealed allocation. Participants allocated to the experimental group will receive usual care and a 2-week package of exercises and strategies that will provide them with additional opportunities to practice a functional task. This package will include a range of strategies individualised to the needs of the participant for increasing the amount of practice of a functional task. Participants allocated to the control group will receive usual care. Usual
care for both groups will consist of two one-hour sessions of physiotherapy a day and will include one-to-one or group therapy with a physiotherapist. This therapy will involve strength, endurance, balance and coordination exercises as well as task-specific practice of sitting, sitting-to-standing, standing, and walking. All exercises will be tailored to the needs of each participant.
Participants:
30 consecutively admitted patients to a sub-acute general adult rehabilitation unit.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34759 0
Mr Davide de Sousa
Address 34759 0
Physiotherapy Department
Graythwaite Rehabilitation Centre
Ryde Hospital
Denistone Road
Eastwood
NSW 2122
Country 34759 0
Australia
Phone 34759 0
+61298587144
Fax 34759 0
Email 34759 0
davide.desousa@health.nsw.gov.au
Contact person for public queries
Name 18006 0
Mr Davide de Sousa
Address 18006 0
Physiotherapy Department
Graythwaite Rehabilitation Centre
Ryde Hospital
Denistone Road
Eastwood
NSW 2122
Country 18006 0
Australia
Phone 18006 0
+61298587144
Fax 18006 0
Email 18006 0
davide.desousa@health.nsw.gov.au
Contact person for scientific queries
Name 8934 0
Mr Davide de Sousa
Address 8934 0
Physiotherapy Department
Graythwaite Rehabilitation Centre
Ryde Hospital
Denistone Road
Eastwood
NSW 2122
Country 8934 0
Australia
Phone 8934 0
+61298587144
Fax 8934 0
Email 8934 0
davide.desousa@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results