A STudy of Upper Arm Rehabilitation in Stroke Survivors- ASTAR (ASTAR)

July 19, 2022 updated by: Dr Khalid Ali

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Haywards Heath, United Kingdom
        • Recruiting
        • University Hospitals Sussex NHS Foundation Trust - Sussex Rehabilitation Centre
        • Contact:
          • Khalid Ali, MBBS FRCP MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Experimental: ARNI care
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Khalid Ali

Collaborators

ARNI Institute for Neurological Rehabilitation (ARNI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Anticipated)

July 8, 2023

Study Completion (Anticipated)

July 8, 2023

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS-254799

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

By request to the Chief Investigator

IPD Sharing Time Frame

Within 3years of study commencement

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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