Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation

Официальное название

Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation (AS-ULDAR)

Обзор

This interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral Sclerosis (ALS), post-stroke sequelae, and Mild Cognitive Impairment (MCI). The system under study combines a collaborative robot (cobot), inertial sensors, and a graphical user interface capable of supporting reaching exercises, trajectory tracking activities, and cognitive exergames, while also enabling automatic acquisition and visualization of patient performance data. The main questions the study aims to answer are: Is the investigational robotic rehabilitation system usable and feasible in neurological patients undergoing upper limb rehabilitation? Is the use of the device safe for both patients and healthcare operators? Does the addition of robotic-assisted rehabilitation to conventional therapy improve upper limb motor performance, cognitive function, and quality of life compared with conventional rehabilitation alone? Do movement measurements collected by the system correlate with standard clinical assessment scales? Researchers will compare conventional rehabilitation therapy plus robotic-assisted rehabilitation with conventional rehabilitation therapy alone to evaluate the impact of the device on motor, cognitive, and psychosocial outcomes. Thirty participants will be randomized into two parallel treatment groups. Both groups will receive 12 sessions of conventional rehabilitation therapy lasting 60 minutes each, three times per week. Participants assigned to the experimental group will additionally receive robotic-assisted rehabilitation sessions of up to 30 minutes supervised by rehabilitation staff. Participants will undergo: Baseline collection of demographic and clinical information; Motor, cognitive, and activities of daily living assessments using standardized clinical scales; Conventional rehabilitation therapy sessions; Robotic-assisted upper limb rehabilitation exercises, including task-oriented and trajectory-tracking activities (experimental group only); Monitoring of vital parameters and adverse events during device use; Final evaluation of usability, psychosocial impact, patient satisfaction, motor and cognitive outcomes, and safety.

Вмешательства

• Устройство Auto-calibrating System for Upper Limb disability Assessment, neurological and occupational Rehabilitation
  Participants will receive 12 sessions of conventional rehabilitation therapy (60 minutes each, three times per week) in addition to training sessions with the investigational robotic device. Device sessions will last up to 30 minutes and will be supervised by rehabilitation staff. The investigational robotic system provides adaptive upper limb rehabilitation exercises tailored to the patient's motor performance. Training includes task-oriented reaching exercises combined with cognitive tasks req
• Другое conventional therapy
  Participants will receive conventional rehabilitation therapy according to standard clinical practice for upper limb motor rehabilitation. Treatment sessions will last 60 minutes, three times per week, for a total of 12 sessions.

Первичные конечные точки

• System Usability Scale (SUS) score [Срок оценки: at the end of treatment (after 12 sessions)]
• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) Score [Срок оценки: At the end of treatment (after 12 sessions)]
• Incidence of Adverse Events [Срок оценки: Throughout the study period (up to 12 sessions)]
• State Trait Anxiety Inventory (STAI) score [Срок оценки: Baseline and end of treatment]
• Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q) Usability Questionnaire Score [Срок оценки: At the end of treatment (after 12 sessions)]
• Perceived Stress Scale (PSS) score [Срок оценки: At the end of the treatment (after 12 sessions).]

Вторичные конечные точки (12)

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score [Срок оценки: Baseline and end of treatment (after 12 sessions)]
• Fugl-Meyer Assessment Score [Срок оценки: Baseline and end of treatment (after 12 sessions)]
• ABILHAND Scale Score [Срок оценки: Baseline and end of treatment (after 12 sessions)]
• Action Research Arm Test (ARAT) Score [Срок оценки: Baseline and end of treatment (after 12 sessions)]
• Modified Ashworth Scale (MAS) Score [Срок оценки: Baseline and end of treatment (after 12 sessions)]
• Bradykinesia Scale Score [Срок оценки: Baseline and end of treatment (after 12 sessions)]
• EuroQol-5D (EQ-5D) Score [Срок оценки: Baseline and end of treatment (after 12 sessions)]
• Psychosocial Impact of Assistive Devices Scale (PIADS) Score [Срок оценки: End of treatment (after 12 sessions)]
• Trail Making Test A score [Срок оценки: Baseline and end of treatment (after 12 sessions)]
• Stroop Test score [Срок оценки: Baseline and end of the treatment (after 12 sessions)]
• Digit Span Test score [Срок оценки: Baseline and end of the treatment (after 12 sessions).]
• Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score [Срок оценки: Baseline and End of the Treatment (after 12 sessions).]

Критерии участия

Критерии включения

• Adult patients aged between 18 and 80 years.
• Confirmed diagnosis of one of the following neurological conditions: stroke, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), or Mild Cognitive Impairment (MCI).
• Presence of upper limb motor impairment defined by QuickDASH scores ranging from 20 to 90.
• Ability to understand and follow the study protocol instructions.

Критерии исключения

• Patients with severe psychiatric disorders or cognitive impairments that interfere with the ability to complete cognitive tests and self-assessment scales.
• Individuals unable to provide informed consent.
• Subjects with moderate to severe cognitive impairment, defined by an ECAS score lower than 81.92 (ALS patients) or a MoCA score between 18 and 25.
• Physical conditions significantly limiting upper limb use (e.g., severe concomitant orthopedic disorders affecting shoulder movement).
• Current or recent participation (within the previous three months) in other rehabilitation programs or interventions that could influence study outcomes.
• Unstable health conditions that could make device use unsafe or inappropriate, including unstable medical conditions or severe visual impairments.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07636538 · ASULDAR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗