Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device: A Crossover Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment Upper and Lower Limb (FMA)
研究概览
简要总结
To verify the non-inferiority, in terms of post-treatment (T1) clinical effectiveness, of a "multidomain" telerehabilitation (TR) protocol compared to conventional outpatient rehabilitation in patients with stroke sequelae, with respect to motor, cognitive, and language functions. The absence of statistically significant differences between the two groups regarding treatment effects for each targeted domain will be considered an indicator of non-inferiority.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years.
- •First diagnosis of ischemic stroke, documented radiologically via CT or MRI scans, corresponding to ICD-9-CM codes 433 and 434 .
- •Presence of aphasia, as assessed by the Aachener Aphasia Test (AAT), and/or cognitive deficits identified through the Oxford Cognitive Screen (OCS).
- •Availability of an ADSL or higher-speed internet connection at the patient's residence.
- •Ability of the patient and/or caregiver to understand and utilize the telerehabilitation system.
- •Provision of written informed consent.
排除标准
- •Contemporanea partecipazione ad altri studi clinici;
- •Decadimento cognitivo
- •Deformità ossee come conseguenza di precedenti eventi traumatici ai 4 arti;
- •Contratture fisse ai 4 arti valutate come 4/4 alla scala di Ashworth modificata (MAS)
- •Altre patologie neurologiche e ortopediche in grado di interferire con lo studio.
结局指标
主要结局
Fugl-Meyer Assessment Upper and Lower Limb (FMA)
时间窗: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.
The Fugl-Meyer Assessment (FMA) is a widely used observational scale for evaluating motor recovery in patients with stroke sequelae. In its version focused on the upper and lower limbs, the FMA measures motor control by assessing specific movements of the shoulder, elbow, wrist, hand, hip, knee, and ankle. Each movement is rated on a three-point scale (0 = absent, 1 = partial, 2 = complete). The maximum score is 66 points for the upper limb and 34 for the lower limb, for a total of 100 points in the overall motor function assessment. Higher scores indicate a greater degree of recovery.
次要结局
- The Trail Making Test - A (TMT-A)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Trail Making Test Part B (TMT-B)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Berg Balance Scale (BBS)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- 10 Meters Walking Test (10MWT)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Timed Up and Go (TUG)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Barthel Index (BI)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Short Form - 36 (SF-36)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Client Satisfaction Questionnaire (CSQ-8)(The test is administered after five weeks of treatment, and four weeks post-treatment.)
- Oxford Cognitive Screen (OCS)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Digit Span Forward (DSF)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Digit Span Backward(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Frontal Assessment Battery (FABit)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Symbol Digit Modalities Test(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
- Hospital Anxiety and Depression Scale (HADS)(The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.)
研究者
Nicola Smania, MD, Clinical Professor
Professor
Universita di Verona