A STudy of Upper Arm Rehabilitation in Stroke Survivors- ASTAR

NCT05300659 | Unknown

• 1 other identifier: IRAS-254799
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Stroke; Upper Limb Injury; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Standard Care

NO INTERVENTION

ARNI care

EXPERIMENTAL

Other: Action for Rehabilitation for Neurological Injury (ARNI)

Interventions

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

ARNI care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Khalid Ali: lead
• ARNI Institute for Neurological Rehabilitation (ARNI): collaborator

Study Sites (1)

University Hospitals Sussex NHS Foundation Trust - Sussex Rehabilitation Centre

Haywards Heath, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke; Arm Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Khalid Ali, FRCP PhD

CONTACT

01273 523368; khalid.ali10@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Blinded research nurse will take upper limb measurements at baseline, after 10 therapy sessions and at 6 months follow up, without knowing which of the two groups participant had been randomized to .
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior lecturer in Geriatrics, BSMS

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 29, 2022
• Study Start: April 4, 2022
• Primary Completion: July 8, 2023
• Study Completion: July 8, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 3years of study commencement

Locations

GB (1)