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NCT05300659: ASTAR
A STudy of Upper Arm Rehabilitation in Stroke Survivors- ASTAR
NA trial testing Action for Rehabilitation for Neurological Injury (ARNI) in Stroke in 36 participants. Status unknown.
8 July 2023
Quick facts
| Lead sponsor | Dr Khalid Ali |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 36 |
| Start date | 4 April 2022 |
| Primary completion | 8 July 2023 |
| Estimated completion | 8 July 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Action for Rehabilitation for Neurological Injury (ARNI)
Conditions studied
- Stroke — all drugs for Stroke →
- Upper Limb Injury — all drugs for Upper Limb Injury →
- Rehabilitation — all drugs for Rehabilitation →
Sponsor
Dr Khalid Ali
Who can join
Adults 18 to 100, any sex, with Stroke or Upper Limb Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05300659
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05300659 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr Khalid Ali
- Last refreshed: 20 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05300659.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing