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Assisted Rehabilitation Care During Post-stroke mANaGement: fEasibiLity Assessment (ARCANGEL)

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ClinicalTrials.gov Identifier: NCT03787433
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
Northern Health and Social Care Trust
Azienda Sanitaria Locale 3, Torino
Information provided by (Responsible Party):
Camlin Ltd

Brief Summary:
The ARCANGEL study evaluates the feasibility of introducing ARC (Assisted Rehabilitation Care), a new device for home-based post-stroke rehabilitation in the current clinical practise. All the stroke survivors included in the study will received their own equipment to be used at home for 6 months.

Condition or disease Intervention/treatment
Stroke Device: ARC - Assisted Rehabilitation Care

Detailed Description:

Some relevant studies have indicated that approximately 36% of these survivors (i.e. more than 9 million in 2013 only) are left with significant disabilities 5 years after their stroke, and >40% (i.e. more than 10 million) require assistance with activities of daily living.

Despite evidence that participation in formal rehabilitative therapies lessens disability after stroke, less than a third receive inpatient or outpatient therapies. Of those who do access therapies, the frequency of use varies by geographic location and socioeconomic status. In this context, the development of new strategies able to expand the access to rehabilitation to an increased number of stroke patients, also enabling home-based conduction and monitoring, are increasingly necessary both for patients, their families and for the healthcare and social services sustainability. Since many barriers could limit access to continuous physical rehabilitation for these patients, devices that complement or assist in the rehabilitation process can be of great help.

Among different approaches proposed by the scientific community, technological systems based on accelerometers seem to be among the most promising. Accelerometers are small low cost electronic devices, able to measure body parts acceleration on three axes. Many researchers have already highlighted that accelerometers have the capability to provide reliable and objective information on quantity and intensity of patient limbs movements during recovery process.

Wearable devices such as accelerometers allow to monitor exercises and daily activities. Machine learning methodologies have already been applied for modelling and contextualizing accelerometric signals to identify activity types (walking, dressing, eating, washing up, etc.) or to recognize to which rehabilitative exercise these signals are linked to. These techniques allow to estimate the recorded movement quality, providing information useful to identify the context in which movements are performed. Results of these type of studies are promising and they demonstrate that machine learning is a preferred approach for accelerometric data analysis, since able to exceed actual limits that today are hampering commercial product development for real time analysis of movement.

Within this scenario, Camlin-ARC takes its place. ARC is a platform based on wearable inertial sensors and machine learning algorithms, designed to bring the rehabilitation at post-stroke patients' home, following hospital discharge.


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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assisted Rehabilitation Care During Post-stroke mANaGement: fEasibiLity Assessment
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
ARC - Assisted Rehabilitation Care
All study participants will be asked to use ARC during for their post-stroke home based rehabilitation for up to 6 months.
Device: ARC - Assisted Rehabilitation Care

ARC is a platform based on wearable inertial sensors and machine learning algorithms, designed to bring the rehabilitation at post-stroke patients' home, following hospital discharge.

The product has been created with the purpose to improve physical skills and patient independence accordingly, in the six months following the acute event. ARC aims to optimize, ease and make more accessible the path of post-stroke rehabilitation during post-acute phase, in real life settings.





Primary Outcome Measures :
  1. Number of patients successfully completing the study [ Time Frame: Through study completion, an average of 15 months ]
    Number of patients completing the 6-month observation period

  2. Ratio between the total number of subjects refusing to participate before training and the total number of subjects screened [ Time Frame: Through study completion, an average of 15 months ]
    Ratio between the total number of patients refusing to participate BEFORE starting trainings and the number of patients screened, as calculated by means of the Screening and Enrollment Log to be completed by each Site, the baseline baseline assessment (reporting a number of training sessions performed, which should be EQUAL TO 0), and the end of study visit.

  3. Ratio between the total number of subjects refusing to participate after training and the total number of subjects screened [ Time Frame: Through study completion, an average of 15 months ]
    Ratio between the total number of patients refusing to participate AFTER training and the total number of patients screened, as calculated by means of the Screening and Enrollment Log to be completed by each Site, the baseline baseline assessment (reporting a number of training sessions performed, which should be at least EQUAL TO 1), and the end of study visit.

  4. Number of training sessions [ Time Frame: Through study completion, an average of 15 months ]
    Average number of training sessions needed for a patient to be able to use ARC at home

  5. Overall training period duration [ Time Frame: Through study completion, an average of 15 months ]
    Average time (days) needed to complete training sessions

  6. Assisted Rehabilitation Care (ARC) questionnaire score [ Time Frame: 6-month assessment ]
    Average score from the ARC questionnaire, specifically designed to assess the following sub-scales: Use of Technology, ARC Usability, Wearability and Global Satisfaction For each dimension, a subscore is calculated as the sum of the value associated to each possible answer (one single answer is allowed for each question), from 1 (Strongly disagree) to 5 (Strongly agree). Finally, the total score is calculated as sum of sub-scores.

  7. Assisted Rehabilitation Care (ARC) questionnaire change [ Time Frame: Evaluations at 3 and 6 months ]
    Change at 6 months of ARC questionnaire score. The change is calculated as difference between the average total score calculated at 6 months and the average total score calculated at 3 months. (Score calculation method ref. Outcome 6)

  8. ARC global satisfaction score [ Time Frame: 6-month assessment ]
    Global score on the ARC user satisfaction ranging from 1 (very low) to 5 (very high).

  9. Modified version of Adult Carer Quality of Life Questionnaire (AC-QoL) total score [ Time Frame: 6-month evaluation ]

    In order to score the AC-QoL use the following scoring framework. Some of the questionnaire items are negatively worded (Value from 0 to 3, Never = 0 - Always = 3) and some are positively worded (Value from 0 to 3, Never = 3 - Always = 0).

    To calculate the total score, a calculation algorithm adds up each row for the score for each sub-scale, and add all the scores for the sub-scales to calculate the overall quality of life score.



Secondary Outcome Measures :
  1. Device-related adverse effects [ Time Frame: Through study completion, an average of 15 months ]
    Number of device-related adverse effects on the total number of adverse events reported.

  2. Modified Rankin Score change (N.Ireland) [ Time Frame: Change at 6-month from baseline ]

    The modified Rankin Score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

    The scale has the following items and associated values:

    No symptoms at all = 0 No significant disability despite symptoms; able to carry out all usual duties and activities = +1 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance = +2 Moderate disability; requiring some help, but able to walk without assistance = +3 Moderately severe disability; unable to walk and attend to bodily needs without assistance = +4 Severe disability; bedridden, incontinent and requiring constant nursing care and attention = +5 Dead = +6 This clinical outcome is used in Northern Ireland (UK) as part of the clinical practice.


  3. Barthel Index change (Italy) [ Time Frame: Baseline assessment and 6-month visit ]
    The Barthel Index for Activities of Daily Living (ADL) assesses functional independence in stroke patients. To each area, a score 0 (=impaired), 5 (needs help) or 10 (=independent) is to be associated. Areas included are: feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, mobility on level surfaces, stairs. Score 5 is not allowed for some of the areas enlisted. The score is calculated as sum of the value achieved in each area. This clinical outcome is used in Italy as part of the clinical practice.

  4. Euro Quality of Life - 5 Dimension (EQ-5D) Health Questionnaire summary index [ Time Frame: 6-month evaluation ]
    Euro Quality of Life - 5 Dimension (EQ-5D) is a standardised instrument that measures the health-related quality of life. It consists of a descriptive system and a Visual Analogue Scale (VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into 3 levels (1 = no problem, 2 = some problems, 3 = to extreme problems). A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is represented by a 5 digit code (eg. 11111 = no problems on any of the 5 dimensions; 11223 = no problems with mobility and self care, some problems with usual activities, moderate pain or discomfort and extreme anxiety or depression). The EQ VAS records the patient's self-rated health (from 100 = best, to 0 = worst imaginable state). The EQ VAS is used to convert the EQ-5D states into a single index value, based on reference values available on EuroQoL Group website.

  5. Euro Quality of Life - 5 Dimension (EQ-5D) Health Questionnaire summary index change [ Time Frame: Baseline assessment and 6-month visit ]

    The Change from baseline measured after 6-month is calculated as the difference between the two average (i.e. 6-month and V0) summary indices.

    The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into 3 levels (1 = no problem, 2 = some problems, 3 = to extreme problems). A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is represented by a 5 digit code (eg. 11111 = no problems on any of the 5 dimensions; 11223 = no problems with mobility and self care, some problems with usual activities, moderate pain or discomfort and extreme anxiety or depression). The EQ VAS records the patient's self-rated health (from 100 = best, to 0 = worst imaginable state). The EQ VAS is used to convert the EQ-5D states into a single index value, based on reference values available on EuroQoL Group website.


  6. Signs of Depression Scale (SODS, N.Ireland) [ Time Frame: Baseline assessment and 6-month visit ]
    Number of patients with a depressive mood, as assessed with the Signs of Depression Scale (SODS, English version used in N.Ireland). The scale consists of 6 questions for which allowed answers are yes (value = 1) or no (Value = 0). The total score is the sum of the values of each answer provided.

  7. Zung Self-Rating Depression Scale (SDS, Italy) [ Time Frame: Baseline assessment and 6-month visit ]

    Number of patients with a depressive mood, as assessed with the Zung Self-Rating Depression Scale (SDS) (Italian validated questionnaire).

    The Zung Self-Rating Depression Scale is a short self-administered survey to quantify the depressed status of a patient. There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities.

    There are ten positively worded and ten negatively worded questions. Each question is scored on a scale of 1-4 (a little of the time, some of the time, good part of the time, most of the time). The scores range from 25-100.


  8. Resource consumption [ Time Frame: Through study completion, an average of 15 months ]
    Average number of unscheduled face-to-face visits required



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients diagnosed with stroke among those admitted to the acute and community hospitals among the Northern Health and Social Care Trust in Northern Ireland, and to Azienda Sanitaria Locale 3, Turin (Italy) will be considered eligible for this study.

Patients will be recruited during their hospital stay, or after hospital discharge, proven they have had a stroke in the previous 6 months. Among these, only patients who have given their informed consent to participate in the study and who meet all the inclusion and exclusion criteria will be considered eligible.

Criteria

Inclusion Criteria:

  • Stroke Diagnosis, with a stable clinical condition
  • Age > 18
  • Modified Rankin score lower or equal to 4 or Barthel Index score greater than 10 at the time of enrollment
  • Patients must be able to keep the standing position without or with minimum assistance
  • Patient giving written consent and engage

Exclusion Criteria:

  • Significant cognitive impairment and behavioral disorders - judged by a responsible clinician
  • Poor communication or reading skills - judged by a Speech and Language Therapist
  • Orthopedic limitation (fractures, amputations, advance osteoarthritis, active rheumatoid arthritis)
  • Head trauma
  • Epilepsy, not pharmacologically controlled
  • Severe spatial neglect
  • Neurodegenerative and neuromuscular diseases
  • Severe spasticity
  • Patient not giving written consent and not engage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787433


Contacts
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Contact: Frances Johnston, MSc +44 (0)28 94424653 ext 334653 frances.johnston@northerntrust.hscni.net

Locations
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Italy
Azienda Sanitaria Locale 3, Torino Recruiting
Pinerolo, Italy, 10064
Contact: Alessandra Revel, MSc    +390121233336    arevel@aslto3.piemonte.it   
Contact: Irene Abbiate, MD    +390121233336    iabbiate@aslto3.piemonte.it   
Principal Investigator: Rodolfo Odoni, MD         
United Kingdom
Northern Health and Social Care Trust Recruiting
Antrim, Northern Ireland, United Kingdom, BT412RL
Contact: Clare McGoldrick, BSc (Hons)    +44(0)2894424000 ext 333088    clare.mcgoldrick@northerntrust.hscni.net   
Contact: Collette Edwards, BSc (Hons)    +44(0)2894424000 ext 333088    collette.edwards@northerntrust.hscni.net   
Principal Investigator: Djamil Vahidassr, MD         
Sponsors and Collaborators
Camlin Ltd
Northern Health and Social Care Trust
Azienda Sanitaria Locale 3, Torino
Investigators
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Study Director: Frances Johnston, MSc Northern Health and Social Care Trust

Publications:
Lara González-Villanueva et al., A Tool for Linguistic Assessment of Rehabilitation Exercises. Applied Soft Computing, Special issue on hybrid intelligent methods for health technologies 14(Part A): 120-31, 2013. doi:10.1016/j.asoc.2013.07.010.
Lara OD, Labrador MA. A Survey on Human Activity Recognition using Wearable Sensors. IEEE Communications Surveys & Tutorial 15(3), 2013.

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Responsible Party: Camlin Ltd
ClinicalTrials.gov Identifier: NCT03787433     History of Changes
Other Study ID Numbers: ARCANGEL
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Camlin Ltd:
Rehabilitation
Accelerometers
Wearable sensors
Artificial Intelligence
Stroke
Home-based Rehabilitation
Activities of Daily Living
Post-stroke rehabilitation

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases