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TOPUPS: Therapy Options for the Upper Limb Study Investigating the effects of a 4-week physiotherapy programme delivered 3 months after stroke

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000863932
Acronym
TOPUPS
Enrollment
5
Registered
2020-08-31
Start date
2020-12-09
Completion date
2022-05-31
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Participants will be offered a 4-week physiotherapy programme beginning at 3 months post-stroke. The hand and arm therapy programme will be delivered by either a registered physiotherapist or registered occupational therapist. 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 d

Participants will be offered a 4-week physiotherapy programme beginning at 3 months post-stroke. The hand and arm therapy programme will be delivered by either a registered physiotherapist or registered occupational therapist. 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 therapy 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 therapy 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 and occupational therapy techniques such as strength training and constraint-induced movement therapy. This therapy programme has been used in previous clinical trials carried out by Professor Winstein and will be adapted for the purposes of this study. Therapy sessions will be tailored to each participant, based on goals identified by each participant that represent real-world tasks. Goals for the therapy programme will be identified at three months post-stroke, prior to beginning the 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 programme will be encouraged through providing each participant with a diary to log their independent practice sessions. The research therapist 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 therapy 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 programme (defined as an ARAT score of more than 45 points out of 57). These participants will instead be offered a 4-week home 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 therapy programme. They will receive weekly video calls with a research therapist 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.

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026