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Trial registered on ANZCTR


Registration number
ACTRN12620000863932p
Ethics application status
Submitted, not yet approved
Date submitted
30/06/2020
Date registered
31/08/2020
Date last updated
31/08/2020
Date data sharing statement initially provided
31/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
TOPUPS: Therapy Options for the Upper Limb Study Investigating the effects of a 4-week physiotherapy programme delivered 3 months after stroke
Scientific title
Therapy Options for the Upper Limb Study (TOPUPS): a prospective, single-site, assessor-blind, quasi-randomised proof-of-concept study of upper limb physiotherapy for patients at the late sub-acute stage of stroke
Secondary ID [1] 301627 0
Nil
Universal Trial Number (UTN)
Trial acronym
TOPUPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 318024 0
Condition category
Condition code
Stroke 316049 316049 0 0
Haemorrhagic
Stroke 316050 316050 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be offered a 4-week physiotherapy programme beginning at 3 months post-stroke. This programme will include 24 sessions in total (6 sessions per week, one hour per session), where 12 sessions are supervised by a research physiotherapist interleaved with 12 sessions completed as independent practice. Supervised sessions are individualised and will be delivered either in person or via telehealth (video call). There will be three groups with varying numbers of in-person and telehealth sessions. These groups are:
- 12 in person sessions, no telehealth sessions
- 6 in-person sessions, 6 telehealth sessions
- 2 in-person sessions, 10 telehealth sessions

All supervised physiotherapy sessions which take place in person may occur either at the University of Auckland, or at the participant's home, depending on the mode of delivery of a session and participant preference. Independent practice sessions will take place at the participant's home, and will follow a similar structure and include similar exercises to the supervised sessions. Assistance will be provided to participants to set up appropriate video calling software on a device for telehealth sessions. If a participant does not have a suitable device required for telehealth sessions, the researchers will provide a tablet on loan for the duration of the programme.

The physiotherapy programme that will be utilised for this study is the Accelerated Skills Acquisition Program, developed by Prof. Carolee Winstein. This standardised programme is a task-oriented, patient centred upper limb programme using conventional physiotherapy techniques such as strength training and constraint-induced movement therapy. This physiotherapy programme has been used in previous clinical trials carried out by Professor Winstein and will be adapted for the purposes of this study. Physiotherapy sessions will be tailored to each participant, based on goals identified by each participant that represent real-world tasks. Goals for the physiotherapy programme will be identified at three months post-stroke, prior to beginning the physiotherapy programme. Examples of possible goals include tasks such as carrying groceries 10 m into the house from the car, or being able to button up a shirt. Where needed, researchers will provide equipment for the key tasks for each participant.

Adherence to the physiotherapy programme will be encouraged through providing each participant with a diary to log their independent practice sessions. The research physiotherapist will be prompted to review the therapy plans for each participant weekly.

The intensity of the supervised and independent sessions will be prescribed using repetitions and task difficulty. For instance, intensity of task practice can be progressed by increasing the number of repetitions that the participant is asked to complete. Intensity can also be progressed by increasing the weight and/or size of objects being lifted or handled. Intensity of fine motor tasks can also be progressed by decreasing the size of objects being handled. Overall, the intensity of practice completed during supervised and independent sessions will be carefully progressed by the research therapist, using combinations of increased repetitions and task difficulty, depending on the goals and current abilities of the participant.

Note that for this study, participants will have three baseline assessments between 2 and 3 months post-stroke before beginning a physiotherapy programme, to monitor recovery progress before the intervention. During this time, some participants may achieve a motor outcome by 3 months post stroke which is too good to continue with the planned physiotherapy programme (defined as an ARAT score of more than 45 points out of 57). These participants will instead be offered a 4-week home physiotherapy programme to complete. This programme will include six one-hour sessions per week of independent practice. Participants will be prescribed exercises based on their personalised task goals, similar to the supervised physiotherapy programme. They will receive weekly video calls with a research physiotherapist during this time, which will help them to progress their therapy programme. Participants will be provided with a diary to record their therapy and report it to researchers, if they wish to do so. The quantitative data from these participants will not be included in the study analyses.

Intervention code [1] 317928 0
Rehabilitation
Comparator / control treatment
The reference comparator for mode of delivery is the entirely in-person mode for the 12 supervised sessions.
Control group
Active

Outcomes
Primary outcome [1] 324263 0
The rate of change in paretic upper limb motor function, measured as the change in Action Research Arm Test (ARAT) score calculated as points per month over 4 weeks immediately prior to the intervention and compared with the rate of change in ARAT score calculated over the 4 week intervention period.
Timepoint [1] 324263 0
ARAT score will be assessed 4 weeks prior to the intervention, immediately before the intervention, immediately after the 4 week intervention, and 4 weeks after the intervention.
Secondary outcome [1] 384199 0
The rate of change in upper limb impairment, assessed using the upper extremity Fugl-Meyer score (UE FM) calculated as points per month over 4 weeks immediately prior to the intervention and compared with the rate of change in UE FM score calculated over the 4 week intervention period.
Timepoint [1] 384199 0
UE FM score will be assessed 4 weeks prior to the intervention, immediately before the intervention, immediately after the 4 week intervention, and 4 weeks after the intervention.
Secondary outcome [2] 384200 0
Participant reported upper limb motor ability, assessed using the ABILHand before and after the intervention.
Timepoint [2] 384200 0
ABILHand scores will be measured immediately before the intervention, immediately after the intervention, and 8 weeks after the intervention.
Secondary outcome [3] 384201 0
Participant reported amount and quality of upper limb movement, assessed using the motor activity log (MAL) before and after the intervention.
Timepoint [3] 384201 0
MAL scores will be measured immediately before the intervention, immediately after the intervention, and 8 weeks after the intervention.

Eligibility
Key inclusion criteria
People with monohemispheric ischaemic stroke or intracerebral haemorrhage admitted to Auckland City Hospital (ACH) within the last two months
MEP+ as indicated by receiving a “Good” or “Excellent” PREP2 prediction while an inpatient at ACH
Have an ARAT score of 45 points or less at 2 months post-stroke
At least 18 years old
Patients treated with intravenous thrombolysis and/or intra-arterial thrombectomy are eligible
Patients with previous stroke are eligible
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognition and/or communication impairment precluding informed consent or engagement with the research procedures, as determined by the patient’s clinical team
Life expectancy less than 12 months, as determined by the patient’s clinical team
Upper limb motor performance limited by pre-existing conditions, such as musculoskeletal disease
Residing out of region precluding in-person assessment
Need for an interpreter


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)
Adaptive quasi-randomisation will be used to assign participants to one of three treatment groups, where the structure of the therapy programme differs by the mode of delivery of supervised physiotherapy sessions. Participants will be able to indicate their preferred group out of either:
- 12 in person sessions, no telehealth sessions
- 6 in-person sessions, 6 telehealth sessions
- 2 in-person sessions, 10 telehealth sessions
Participants will be randomised to either their first or second preference. If the number of participants already randomised to their first preference exceeds the number of participants randomised to either of the other groups by 3 or more, the first preference will be unavailable and they will be randomised to their second or third preference. Randomisation will take into account geographical location and participant preference.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will use custom software to minimise between-group differences in age and whether TMS was used to obtain the patient’s PREP2 prediction. Assessing researchers will remind blinded to the group allocation of each participant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
This is a small proof-of-concept pilot study designed to evaluate the potential usefulness of exploring the use of an intensive therapy program at 12 weeks post-stroke to improve upper limb motor outcomes. In this study, the rate of improvement in upper limb function during the therapy intervention will be compared to the rate of improvement before the physiotherapy program. The results of this study may be used as part of the rationale for a larger randomized controlled trial to determine the efficacy of a physiotherapy program at 12 weeks post-stroke in this specific stroke population.

This study will recruit people 8 weeks post-stroke, prior to beginning the intervention programme at 12 weeks post-stroke. Participants must not have achieved an ARAT score > 45 points by 12 weeks post-stroke. Any participants who achieve above 45 points by this time point will be offered an independent home therapy programme with weekly video calls with a physiotherapist. This programme will include tasks based on real-world goals set by participants similar to the supervised programme. Data from these participants will not be used in statistical analyses.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The planned sample size for this study is 30 participants. Allowing for an estimated 20% loss to follow up, the sample size available for evaluating the effects of the therapy programme will be 24 participants (8 per treatment group). However, we anticipate that a proportion of consented participants will achieve an ARAT score > 45 by 12 weeks post-stroke, and will therefore be offered the independent therapy programme. Their data will be withdrawn from statistical analysis. We will therefore consent up to 60 participants to obtain a sample of 30 participants enrolled in the supervised therapy programme.

The primary outcome measure is change in ARAT score (points per month), measured between two and three months post-stroke prior to the intervention period, and during the intervention period between three and four months post-stroke. The primary outcome will be analysed with a two-tailed paired-samples t-test of change in ARAT calculated over the 4 weeks prior to and during the intervention, regardless of the mode of delivery, using data from all participants. Based on our previous work, MEP+ stroke patients demonstrate a mean change in ARAT of 2.7 points per month between 6 and 12 weeks post-stroke, with a standard deviation of 2.2 points per month. We will consider a mean change in ARAT of 5.4 points per month during the intervention, with a standard deviation of 4.4 points per month, to be clinically meaningful. A doubling of mean change in ARAT from 2.7 to 5.4 points per month would represent an intervention effect size of 0.71. Assuming a = 0.05, a sample size of 24 participants will allow us to detect an intervention effect size of 0.71 with 90% power. A sample of 24 participants would also allow us to detect an effect size of 0.39 for the mode of delivery with 90% power, assuming 8 participants per group, when analysed with a repeated measures ANOVA. A total of 30 participants will be recruited to allow for a 20% loss to follow up.

Secondary outcome analysis:
A repeated measures ANOVA will be completed to examine the effect of mode of delivery on change in UEFM score/month before and during the intervention. The ABILHand and MAL scores at three, four and six months will be analysed using repeated measures ANOVA as above, or non-parametric alternatives if the data are not normally distributed

Recruitment
Recruitment status
Not yet 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 outside Australia
Country [1] 22697 0
New Zealand
State/province [1] 22697 0

Funding & Sponsors
Funding source category [1] 306067 0
Charities/Societies/Foundations
Name [1] 306067 0
Neurological Foundation of New Zealand
Address [1] 306067 0
66 Grafton Road, Grafton, Auckland 1010
Country [1] 306067 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 306526 0
None
Name [1] 306526 0
None
Address [1] 306526 0
None
Country [1] 306526 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306283 0
Health and Disabilities Ethics Committee
Ethics committee address [1] 306283 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306283 0
New Zealand
Date submitted for ethics approval [1] 306283 0
06/07/2020
Approval date [1] 306283 0
Ethics approval number [1] 306283 0

Summary
Brief summary
People admitted to Auckland City Hospital with stroke are offered a prediction for their hand and arm recovery as part of routine clinical care, using a validated prediction tool. Unfortunately those who have the potential for an Excellent recovery don’t always achieve their full potential within 3 months of their stroke. This study will explore whether a boost of intensive physiotherapy starting 3 months after stroke can help people achieve their full potential for hand and arm function. Potential participants will be approached during their hospital stay, and asked for their permission to contact them about 6 weeks after their stroke. If they agree, we will send them some information about the study, and then discuss it with them to see whether they are interested in taking part. Those who consent to participation will complete some clinical assessments between 2 and 3 months post-stroke, and then begin a therapy programme at 3 months. The programme involves a combination of supervised and unsupervised therapy sessions, one hour per day, six days per week. The physiotherapist will provide therapy in person or via videocall, or a combination of both, in accordance with participant preference wherever possible. Follow-up assessments will be made by a blinded researcher at the end of the four-week therapy programme, and again at 5 and 6 months stroke. This small-scale proof-of-concept pilot study will enrol up to 30 participants, and includes a qualitative component to understand the experiences of patients and whanau.
Trial website
Trial related presentations / publications
Public notes
Randomisation to one of the intervention delivery modes will also consider COVID-19 alert level status.

Contacts
Principal investigator
Name 103362 0
Prof Cathy Stinear
Address 103362 0
Department of Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 103362 0
New Zealand
Phone 103362 0
+64 9 92 33 779
Fax 103362 0
Email 103362 0
c.stinear@auckland.ac.nz
Contact person for public queries
Name 103363 0
Prof Cathy Stinear
Address 103363 0
Department of Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 103363 0
New Zealand
Phone 103363 0
+64 9 92 33 779
Fax 103363 0
Email 103363 0
c.stinear@auckland.ac.nz
Contact person for scientific queries
Name 103364 0
Prof Cathy Stinear
Address 103364 0
Department of Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 103364 0
New Zealand
Phone 103364 0
+64 9 92 33 779
Fax 103364 0
Email 103364 0
c.stinear@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised individual participant data that form the basis of reports of this trial.
When will data be available (start and end dates)?
Anonymised data will be made available from 3 months after publication of the study's main results, for a period of 5 years.
Available to whom?
Anonymised data will be made available to researchers who make a reasonable request for access with a sound research proposal, at the discretion of the principal investigator.
Available for what types of analyses?
Any analyses.
How or where can data be obtained?
Access will be subject to approval by the principal investigator, with a signed data access agreement in place. Access can be requested via email to the principal investigator c.stinear@auckland.ac.nz
What supporting documents are/will be available?
No other documents available
Summary results
No Results