StrokeASTARNCT05300659
A STudy of Upper Arm Rehabilitation in Stroke Survivors- ASTAR
A study testing Action for Rehabilitation for Neurological Injury (ARNI) in people with Stroke and Upper Limb Injury, run by Dr Khalid Ali at 1 site in United Kingdom.
Trial summary
This feasibility study will explore the clinical effectiveness of additional upper limb therapy compared to standard care delivered to Stroke Survivors at Sussex Rehabilitation Centre (SRC). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Upper Limb Injury, Rehabilitation
- What is being tested?
- Action for Rehabilitation for Neurological Injury (ARNI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Apr 2022to 8 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke Survivors admitted to Sussex Rehabilitation Centre
- Aged 18 years or over
- Have an upper limb affected by stroke
- Have capacity to consent to participate in the study
- Medically stable
Who cannot join
- Aged under 18 years
- AMTS <8
- Have a neurological deficit which does not involve upper limb
- Presence of a terminal illness with shortened life expectancy <6 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Sussex NHS Foundation Trust - Sussex Rehabilitation Centre
Haywards Heath
Khalid Ali, MBBS FRCP MD
About this study
Official title: Feasibility of an Upper Limb Functional Training Programme to Support Self-management in Stroke Survivors (ASTAR)
This feasibility study will explore the clinical effectiveness of additional upper limb therapy compared to standard care delivered to Stroke Survivors at Sussex Rehabilitation Centre (SRC). Randomization via sealed envelope will allocate treatment group to either routine care or upper limb training for self-management plus routine care. If randomized to upper limb training, a patient will undertake 10 therapy sessions with an instructor from the Action for Rehabilitation for Neurological Injury (ARNI) program during their hospital stay. The last two ARNI-led sessions will be filmed by a nurse/carer on either their own tablet/phone or an i-pad. Participants in the ARNI group will be encouraged to continue doing their personalized exercises while in hospital and continued at home. The participants in the ARNI group will also be given a task-training board to take home.
This randomized controlled trial will measure outcomes of each group over six months. Each patient in the study will have upper limb physical measurements taken by a blinded Research Nurse (RN2) at baseline. Research Nurse (RN1) will gather data in a Clinical Report File from a weekly exercise diary completed by the patient or carer and well-being questionnaires. On discharge, RN2 will conduct upper limb measurements, collect completed hospital diaries and issue new ones to take4 home. RN1 will give a weekly phone call or text reminders so that patients to complete exercise diaries at home. At 6 months RN2 will do final measurements and complete patient questionnaires in an out patients clinic visit.
Read more
The investigators aim to recruit 36 patients and anticipate 30(8.3%) will complete the 6 month follow-up.
The study sponsor will be the University of Sussex. However, as the study is run in rehabilitation unit in an NHS hospital, University Hospitals Sussex NHS Trust will host the study.
- Conditions
- Stroke, Upper Limb Injury, Rehabilitation
- Being tested
- Action for Rehabilitation for Neurological Injury (ARNI)
- Medical subject headings
- Stroke, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action for Rehabilitation for Neurological Injury (ARNI)Other
If randomised to upper limb training, a patient will undertake 10 therapy sessions with an instructor from the Action for Rehabilitation for Neurological Injury (ARNI) program during their hospital stay. The last two ARNI-led sessions will be filmed by a nurse/carer on either their own tablet/phone or an i-pad. Participants in the ARNI group will be encouraged to continue doing their personalized exercises while in hospital and continued at home. They will also be given a task-training board to take home
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Not described |
| ARNI care | Experimental | Not described Receives: Other: Action for Rehabilitation for Neurological Injury (ARNI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants retained in this feasibility study.
Investigators hypothesize that an ARNI approach to upper limb therapy following stroke will be feasible to implement in a standard NHS rehabilitation unit resulting in better upper limb recovery through providing more intensity and enhancing self-management. If the study proves to be feasible - retention of at least 30/36 patients and at least 70% of data relating to exercise intensity, it can be rolled out to several rehabilitation units across the UK. A follow-up multi-centre randomized controlled trial of ARNI-led upper limb therapy plus usual care compared to usual care will then be carried out to provide clinical and cost effectiveness of the ARNI approach. Upper limb function outcomes: Fugl-Meyer test, Action Research Arm Test. Some questionnaires will be used to assess the psychological well-being of patients and carers: Stroke self-efficacy questionnaire, Stroke carer burden scale (CBS), Stroke specific QOL scale, Stroke Impact Scale (SIS) and EQ-5D.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start4 Apr 2022
- Primary completion8 Jul 2023 (estimated)
- Study completion8 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Khalid Ali
- Sponsor type
- University, hospital or other
- Collaborators
- ARNI Institute for Neurological Rehabilitation (ARNI)
- Responsible party
- Sponsor-investigator, Dr Khalid Ali, Brighton & Sussex Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300659
- Sponsor's protocol ID
- IRAS-254799
- Acronym
- ASTAR
- Status last verified
- Jul 2022
- First submitted
- 16 Mar 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By request to the Chief Investigator
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Upper Limb Functional Training Programme to Support Self-management in Stroke Survivors (ASTAR)
- ClinicalTrials.gov ID
- NCT05300659
- Acronym / sponsor ID
- ASTAR / IRAS-254799
- Conditions
- Stroke, Upper Limb Injury, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Dr Khalid AliUniversity, hospital or other
- Collaborators
- ARNI Institute for Neurological Rehabilitation (ARNI)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 8 Jul 2023 (estimated)
- Study completion
- 8 Jul 2023 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study will explore the clinical effectiveness of additional upper limb therapy compared to standard care delivered to Stroke Survivors at Sussex Rehabilitation Centre (SRC). Randomization via sealed envelope will allocate treatment group to either routine care or upper limb training for self-management plus routine care. If randomized to upper limb training, a patient will undertake 10 therapy sessions with an instructor from the Action for Rehabilitation for Neurological Injury (ARNI) program during their hospital stay. The last two ARNI-led sessions will be filmed by a nurse/carer on either their own tablet/phone or an i-pad. Participants in the ARNI group will be encouraged to continue doing their personalized exercises while in hospital and continued at home. The participants in the ARNI group will also be given a task-training board to take home.
This randomized controlled trial will measure outcomes of each group over six months. Each patient in the study will have upper limb physical measurements taken by a blinded Research Nurse (RN2) at baseline. Research Nurse (RN1) will gather data in a Clinical Report File from a weekly exercise diary completed by the patient or carer and well-being questionnaires. On discharge, RN2 will conduct upper limb measurements, collect completed hospital diaries and issue new ones to take4 home. RN1 will give a weekly phone call or text reminders so that patients to complete exercise diaries at home. At 6 months RN2 will do final measurements and complete patient questionnaires in an out patients clinic visit.
The investigators aim to recruit 36 patients and anticipate 30(8.3%) will complete the 6 month follow-up.
The study sponsor will be the University of Sussex. However, as the study is run in rehabilitation unit in an NHS hospital, University Hospitals Sussex NHS Trust will host the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | – |
| ARNI care | Experimental | Other: Action for Rehabilitation for Neurological Injury (ARNI) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stroke Survivors admitted to Sussex Rehabilitation Centre
- Aged 18 years or over
- Have an upper limb affected by stroke
- Have capacity to consent to participate in the study
- Medically stable
Key exclusion criteria (4 listed)
- Aged under 18 years
- AMTS <8
- Have a neurological deficit which does not involve upper limb
- Presence of a terminal illness with shortened life expectancy <6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action for Rehabilitation for Neurological Injury (ARNI)If randomised to upper limb training, a patient will undertake 10 therapy sessions with an instructor from the Action for Rehabilitation for Neurological Injury (ARNI) program during their hospital stay. The last two ARNI-led sessions will be filmed by a nurse/carer on either their own tablet/phone or an i-pad. Participants in the ARNI group will be encouraged to continue doing their personalized exercises while in hospital and continued at home. They will also be given a task-training board to take home | Other | ARNI care |
Primary outcome
Number of participants retained in this feasibility study.
Time frame: 6 months
Investigators hypothesize that an ARNI approach to upper limb therapy following stroke will be feasible to implement in a standard NHS rehabilitation unit resulting in better upper limb recovery through providing more intensity and enhancing self-management. If the study proves to be feasible - retention of at least 30/36 patients and at least 70% of data relating to exercise intensity, it can be rolled out to several rehabilitation units across the UK. A follow-up multi-centre randomized controlled trial of ARNI-led upper limb therapy plus usual care compared to usual care will then be carried out to provide clinical and cost effectiveness of the ARNI approach. Upper limb function outcomes: Fugl-Meyer test, Action Research Arm Test. Some questionnaires will be used to assess the psychological well-being of patients and carers: Stroke self-efficacy questionnaire, Stroke carer burden scale (CBS), Stroke specific QOL scale, Stroke Impact Scale (SIS) and EQ-5D.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Yes. By request to the Chief Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action for Rehabilitation for Neurological Injury (ARNI) in people with Stroke and Upper Limb Injury, run by Dr Khalid Ali at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khalid Ali, FRCP PhD (01273 523368, khalid.ali10@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants retained in this feasibility study. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.