Effects of Using Advanced NEUROrehabilitation TECHnologies in Upper Limb Motor Function and Capacity Recovery in People With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
研究概览
简要总结
This study aims to evaluate the effect of a personalized technology-based rehabilitative intervention on Upper Limb (UL) motor function and capacity recovery in People with Stroke (PwS). The study is single-cohort study in which eligible participants will undergo baseline and follow-up clinical and instrumental assessments over a 4-5 week period.
The intervention consists of a personalized and specific upper limb technology-based rehabilitation programme delivered three times per week for a total of 12-15 sessions. Each session lasts approximately one hour and is integrated with conventional rehabilitation treatments.
Primary outcomes include Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT). Secondary outcomes include instrumental assessment of active range of motion and grip strength.
详细描述
Stroke is the second leading cause of death and the third leading cause of disability worldwide. The prevalence of upper limb motor deficits ranges approximately from 50-80% in the acute phase and from 40-50% in the chronic phase, six months after the event.
The most common upper limb impairments following stroke include paresis, altered muscle tone, reduced sensation, and loss of coordination. These deficits compromise the ability to perform activities of daily living, such as opening a door, grasping a key, or using a computer. Consequently, the recovery of upper limb motor function and capacity represents one of the primary goals of post-stroke rehabilitation.
The literature further highlights that treatment intensity, defined as a high number of repetitions, and task-oriented approaches are among the main determinants of rehabilitation effectiveness after stroke. In this context, rehabilitation technologies enable automation and intensification of treatment paradigms, improve access to therapy, and provide physiotherapists with innovative tools.
The application of these technologies in neurorehabilitation, particularly for upper limb motor recovery in adults with stroke, has led to numerous clinical studies investigating their effectiveness. Robotic rehabilitation has generally been associated with improvements in upper limb motor function. Overall, evidence indicates that technology-based interventions, such as robot-assisted therapy, virtual reality, and telerehabilitation, can enhance motor recovery when used alongside conventional treatment, particularly in individuals with moderate to severe impairments. More recent summaries of the literature further support the added value of robot-assisted approaches compared with conventional therapy alone.
Despite the growing body of evidence, several challenges remain, including population heterogeneity, variability in devices, non-standardized treatment dosage, and the lack of specific intervention parameters.
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
- •Age ≥ 18 years;
- •First-ever unilateral ischemic or hemorrhagic stroke;
- •Presence of upper limb motor impairment;
- •Modified Ashworth Scale (MAS) < 3;
- •Montreal Cognitive Assessment (MoCA) > 24;
- •Medically stable and able to participate in an intensive rehabilitation programme;
- •Ability to understand and follow study procedures;
- •Written informed consent.
排除标准
- •Diagnosis of severe aphasia, based on medical records, preventing participation;
- •Bilateral hemisphere lesions;
- •Severe and unstable medical conditions (e.g. untreated seizure, heart failure) that preclude participation in rehabilitation;
- •Other neurological and/or psychiatric diseases;
- •Recent and unstabilized upper limb fracture.
研究组 & 干预措施
PwS
Adult People with Stroke (PwS) with Upper Limb (UL) motor function impairment
干预措施: Technology-based UL rehabilitation (Device)
结局指标
主要结局
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
时间窗: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is an ordinal scale used to assess sensorimotor function following stroke. The upper extremity motor function section includes four subscales assessing synergistic and non-synergistic movements of shoulder, elbow, wrist and hand, as well as coordination/speed. The maximum score is 66 points, indicating normal upper limb motor function. In addition to motor function, the FMA-UE assesses Non-motor domains (i.e., sensation, passive joint movement and pain), with a maximum total score of 60 points.
Action Research Arm Test (ARAT)
时间窗: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)
Action Research Arm Test (ARAT) consists of 19 items grouped in subtests (i.e., grasp, grip, pinch, and gross arm movement) and performance of each item rated on a 4 points scale (from 0 - no movement possible, to 3 - movement performed normally.
次要结局
- Instrumented Active Range of Motion (AROM) of affected Upper Limb(Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1))
- Instrumental gross and fine motor grip strength of hand affected(Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1))
研究者
Gianfranco Lamberti, MD
MD
Azienda Unita Sanitaria Locale di Piacenza