Assisted Rehabilitation Care During Post-stroke mANaGement: fEasibiLity Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Number of patients successfully completing the study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of patients successfully completing the study
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Through study completion, an average of 15 months
Average time (days) needed to complete training sessions
Assisted Rehabilitation Care (ARC) questionnaire score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Device-related adverse effects(Through study completion, an average of 15 months)
- Modified Rankin Score change (N.Ireland)(Change at 6-month from baseline)
- Barthel Index change (Italy)(Baseline assessment and 6-month visit)
- Euro Quality of Life - 5 Dimension (EQ-5D) Health Questionnaire summary index(6-month evaluation)
- Euro Quality of Life - 5 Dimension (EQ-5D) Health Questionnaire summary index change(Baseline assessment and 6-month visit)
- Signs of Depression Scale (SODS, N.Ireland)(Baseline assessment and 6-month visit)
- Zung Self-Rating Depression Scale (SDS, Italy)(Baseline assessment and 6-month visit)
- Resource consumption(Through study completion, an average of 15 months)