ARCANGEL STUDY v1.0
Research type
Research Study
Full title
Assisted Rehabilitation Care during post-stroke mANaGement: fEasibiLity assessment
IRAS ID
244275
Contact name
Frances Johnston
Contact email
Sponsor organisation
Camlin Technologies Ltd
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
ARCANGEL is a prospective study of patients who have been diagnosed with stroke. The primary aim is to determine the feasibility of introducing a new device, Camlin-ARC, in the current practice of stroke patients’ rehabilitation.
It will be composed of 5 main stages:Recruitment process and Consent: Patients will be identified by the Medical team and referred to the Stroke Research Nurse in line with the inclusion criteria. All patients will receive a patient information sheet to sign prior to enrolling enabling the patient to make an informed choice to participate.
Training: During patient stay in the community service, patients will be trained to be able to use of the new technology autonomously at their own home.
Baseline Assessment: Immediately prior to discharge, a baseline will be established for each patient, including the Barthel Index Score and the Modified Rankin Score.
Introduction of Camlin-ARC in the conventional rehabilitation: During post-acute phase, after discharge from the hospital and before starting a physical rehabilitation program, patients will be provided with an ARC system kit, and they will be asked to use ARC at home according to the rehabilitation program defined by their therapist.
Outcome Assessment: Follow up visits will be scheduled according to the current clinical practice, with at least a visit after 6 months after discharge, to collect clinical outcomes (Modified Rankin Score or Barthel Index, EQ-5D Health Questionnaire, S.O.D.S). At the 6-month visit, two device-related questionnaires will also be administered, one to the patient (ARC Questionnaire) and one to their caregiver (mAC-QoL, Modified version of the Adult Carer Quality of Life Questionnaire).
REC name
HSC REC A
REC reference
18/NI/0058
Date of REC Opinion
19 Apr 2018
REC opinion
Further Information Favourable Opinion