StrokeARCANGELNCT03787433
Assisted Rehabilitation Care During Post-stroke mANaGement: fEasibiLity Assessment
An observational study of Stroke, run by Camlin Ltd at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- ARC - Assisted Rehabilitation Care
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Nov 2018to 12 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Neurodegenerative and neuromuscular diseases
- Severe spasticity
- Patient not giving written consent and not engage
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Northern Health and Social Care Trust
Antrim, Northern Ireland, BT412RL
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- ARC - Assisted Rehabilitation Care
- Keywords
- Rehabilitation, Accelerometers, Wearable sensors, Artificial Intelligence, Stroke, Home-based Rehabilitation, Activities of Daily Living, Post-stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC - Assisted Rehabilitation CareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ARC - Assisted Rehabilitation Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients successfully completing the study
Number of patients completing the 6-month observation period
Measured: Through study completion, an average of 15 months
Ratio between the total number of subjects refusing to participate before training and the total number of subjects screened
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.
Measured: Through study completion, an average of 15 months
Ratio between the total number of subjects refusing to participate after training and the total number of subjects screened
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.
Measured: Through study completion, an average of 15 months
Number of training sessions
Average number of training sessions needed for a patient to be able to use ARC at home
Measured: Through study completion, an average of 15 months
Overall training period duration
Average time (days) needed to complete training sessions
Measured: Through study completion, an average of 15 months
Assisted Rehabilitation Care (ARC) questionnaire score
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.
Measured: 6-month assessment
Assisted Rehabilitation Care (ARC) questionnaire change
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)
Measured: Evaluations at 3 and 6 months
ARC global satisfaction score
Global score on the ARC user satisfaction ranging from 1 (very low) to 5 (very high).
Measured: 6-month assessment
Modified version of Adult Carer Quality of Life Questionnaire (AC-QoL) total score
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.
Measured: 6-month evaluation
Secondary outcomes (8)
Device-related adverse effects
Number of device-related adverse effects on the total number of adverse events reported.
Measured: Through study completion, an average of 15 months
Modified Rankin Score change (N.Ireland)
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.
Measured: Change at 6-month from baseline
Barthel Index change (Italy)
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.
Measured: Baseline assessment and 6-month visit
Euro Quality of Life - 5 Dimension (EQ-5D) Health Questionnaire summary index
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.
Measured: 6-month evaluation
Euro Quality of Life - 5 Dimension (EQ-5D) Health Questionnaire summary index change
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.
Measured: Baseline assessment and 6-month visit
Signs of Depression Scale (SODS, N.Ireland)
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.
Measured: Baseline assessment and 6-month visit
Zung Self-Rating Depression Scale (SDS, Italy)
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.
Measured: Baseline assessment and 6-month visit
Resource consumption
Average number of unscheduled face-to-face visits required
Measured: Through study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start23 Nov 2018
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camlin Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northern Health and Social Care Trust, Azienda Sanitaria Locale 3, Torino
- Responsible party
- Sponsor
- Investigators
- Frances Johnston, MSc, Study director, Northern Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787433
- Sponsor's protocol ID
- ARCANGEL
- Acronym
- ARCANGEL
- Status last verified
- Jun 2020
- First submitted
- 13 Dec 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krueger H, Koot J, Hall RE, O'Callaghan C, Bayley M, Corbett D. Prevalence of Individuals Experiencing the Effects of Stroke in Canada: Trends and Projections. Stroke. 2015 Aug;46(8):2226-31. doi: 10.1161/STROKEAHA.115.009616.
PubMed 26205371Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.
PubMed 16120836Hankey GJ, Jamrozik K, Broadhurst RJ, Forbes S, Anderson CS. Long-term disability after first-ever stroke and related prognostic factors in the Perth Community Stroke Study, 1989-1990. Stroke. 2002 Apr;33(4):1034-40. doi: 10.1161/01.str.0000012515.66889.24.
PubMed 11935057Hackett ML, Duncan JR, Anderson CS, Broad JB, Bonita R. Health-related quality of life among long-term survivors of stroke : results from the Auckland Stroke Study, 1991-1992. Stroke. 2000 Feb;31(2):440-7. doi: 10.1161/01.str.31.2.440.
PubMed 10657420Dobkin BH, Dorsch A. New evidence for therapies in stroke rehabilitation. Curr Atheroscler Rep. 2013 Jun;15(6):331. doi: 10.1007/s11883-013-0331-y.
PubMed 23591673Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.
PubMed 25297823Uswatte G, Foo WL, Olmstead H, Lopez K, Holand A, Simms LB. Ambulatory monitoring of arm movement using accelerometry: an objective measure of upper-extremity rehabilitation in persons with chronic stroke. Arch Phys Med Rehabil. 2005 Jul;86(7):1498-501. doi: 10.1016/j.apmr.2005.01.010.
PubMed 16003690Wong WY, Wong MS, Lo KH. Clinical applications of sensors for human posture and movement analysis: a review. Prosthet Orthot Int. 2007 Mar;31(1):62-75. doi: 10.1080/03093640600983949.
PubMed 17365886Zhou H, Hu H, Harris N. Application of wearable inertial sensors in stroke rehabilitation. Conf Proc IEEE Eng Med Biol Soc. 2005;2005:6825-8. doi: 10.1109/IEMBS.2005.1616072.
PubMed 17281841Lara 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.
Mannini A, Sabatini AM. Machine learning methods for classifying human physical activity from on-body accelerometers. Sensors (Basel). 2010;10(2):1154-75. doi: 10.3390/s100201154. Epub 2010 Feb 1.
PubMed 22205862Parkka J, Ermes M, Korpipaa P, Mantyjarvi J, Peltola J, Korhonen I. Activity classification using realistic data from wearable sensors. IEEE Trans Inf Technol Biomed. 2006 Jan;10(1):119-28. doi: 10.1109/titb.2005.856863.
PubMed 16445257Lara OD, Labrador MA. A Survey on Human Activity Recognition using Wearable Sensors. IEEE Communications Surveys & Tutorial 15(3), 2013.
Garcia-Ceja E, Brena RF, Carrasco-Jimenez JC, Garrido L. Long-term activity recognition from wristwatch accelerometer data. Sensors (Basel). 2014 Nov 27;14(12):22500-24. doi: 10.3390/s141222500.
PubMed 25436652
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisted Rehabilitation Care During Post-stroke mANaGement: fEasibiLity Assessment
- ClinicalTrials.gov ID
- NCT03787433
- Acronym / sponsor ID
- ARCANGEL / ARCANGEL
- Conditions
- Stroke
- Keywords
- Rehabilitation, Accelerometers, Wearable sensors, Artificial Intelligence, Stroke, Home-based Rehabilitation, Activities of Daily Living, Post-stroke rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Camlin LtdIndustry (pharma, biotech, devices)
- Collaborators
- Northern Health and Social Care Trust, Azienda Sanitaria Locale 3, Torino
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARC - Assisted Rehabilitation Care | – | Device: ARC - Assisted Rehabilitation CareAll study participants will be asked to use ARC during for their post-stroke home based rehabilitation for up to 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC - Assisted Rehabilitation CareARC 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. | Device | ARC - Assisted Rehabilitation Care |
Primary outcome
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
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.
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.
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
Overall training period duration
Time frame: Through study completion, an average of 15 months
Average time (days) needed to complete training sessions
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.
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)
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).
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.
8 secondary outcomes
Device-related adverse effects
Time frame: Through study completion, an average of 15 months
Modified Rankin Score change (N.Ireland)
Time frame: Change at 6-month from baseline
Barthel Index change (Italy)
Time frame: Baseline assessment and 6-month visit
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) Health Questionnaire summary index change
Time frame: Baseline assessment and 6-month visit
Signs of Depression Scale (SODS, N.Ireland)
Time frame: Baseline assessment and 6-month visit
Zung Self-Rating Depression Scale (SDS, Italy)
Time frame: Baseline assessment and 6-month visit
Resource consumption
Time frame: Through study completion, an average of 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 26205371Krueger H, Koot J, Hall RE, O'Callaghan C, Bayley M, Corbett D. Prevalence of Individuals Experiencing the Effects of Stroke in Canada: Trends and Projections. Stroke. 2015 Aug;46(8):2226-31. doi: 10.1161/STROKEAHA.115.009616.
- Background: PubMed 16120836Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.
- Background: PubMed 11935057Hankey GJ, Jamrozik K, Broadhurst RJ, Forbes S, Anderson CS. Long-term disability after first-ever stroke and related prognostic factors in the Perth Community Stroke Study, 1989-1990. Stroke. 2002 Apr;33(4):1034-40. doi: 10.1161/01.str.0000012515.66889.24.
- Background: PubMed 10657420Hackett ML, Duncan JR, Anderson CS, Broad JB, Bonita R. Health-related quality of life among long-term survivors of stroke : results from the Auckland Stroke Study, 1991-1992. Stroke. 2000 Feb;31(2):440-7. doi: 10.1161/01.str.31.2.440.
- Background: PubMed 23591673Dobkin BH, Dorsch A. New evidence for therapies in stroke rehabilitation. Curr Atheroscler Rep. 2013 Jun;15(6):331. doi: 10.1007/s11883-013-0331-y.
- Background: PubMed 25297823Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.
- Background: PubMed 16003690Uswatte G, Foo WL, Olmstead H, Lopez K, Holand A, Simms LB. Ambulatory monitoring of arm movement using accelerometry: an objective measure of upper-extremity rehabilitation in persons with chronic stroke. Arch Phys Med Rehabil. 2005 Jul;86(7):1498-501. doi: 10.1016/j.apmr.2005.01.010.
- Background: PubMed 17365886Wong WY, Wong MS, Lo KH. Clinical applications of sensors for human posture and movement analysis: a review. Prosthet Orthot Int. 2007 Mar;31(1):62-75. doi: 10.1080/03093640600983949.
- Background: PubMed 17281841Zhou H, Hu H, Harris N. Application of wearable inertial sensors in stroke rehabilitation. Conf Proc IEEE Eng Med Biol Soc. 2005;2005:6825-8. doi: 10.1109/IEMBS.2005.1616072.
- BackgroundLara 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.
- Background: PubMed 22205862Mannini A, Sabatini AM. Machine learning methods for classifying human physical activity from on-body accelerometers. Sensors (Basel). 2010;10(2):1154-75. doi: 10.3390/s100201154. Epub 2010 Feb 1.
- Background: PubMed 16445257Parkka J, Ermes M, Korpipaa P, Mantyjarvi J, Peltola J, Korhonen I. Activity classification using realistic data from wearable sensors. IEEE Trans Inf Technol Biomed. 2006 Jan;10(1):119-28. doi: 10.1109/titb.2005.856863.
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Johnston, MSc study director
Northern Health and Social Care Trust
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Camlin Ltd at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients successfully completing the study (time frame: Through study completion, an average of 15 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03787433, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.