Assessment of a Upper Limb Robotic Device in Stroke Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Fugl Meyer Assessment Upper Limb (FMA-UL)
研究概览
简要总结
The objectives of this phase II clinical study are: evaluate the efficacy, safety, patient adeherence and clinical applicability of a new robotic device for patients with stroke at a physical rehabilitation institution (Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Universidade de São Paulo - IMREA HCFMUSP - Rede de Reabilitação Lucy Montoro, unidade Vila Mariana). Methods: 10 patients with stroke diagnosis and Fugl-Meyer score ranging from 34 to 55 will be selected to be included in the study. After signing the informed consent form and being assessed by the baseline evaluations, they will undertake 18 sessions of robotic therapy, which in its turn will be prescribed three times a week. After this period, the patients will be evaluated for future comparison of both the pre-treatment and final assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Joint, muscle or tendinous lesions and/or pain that can occur during the intervention and make it difficult or impossible to perform robotic tasks.
- •Progressive worsening of spasticity.
- •Withdrawal of the informed consent form.
- •New episode of stroke.
- •Comorbidities that may occur during interventions such as hypertension, seizures, diabetes, among other uncontrolled clinical issues.
研究组 & 干预措施
Robotic Therapy
After consent, 10 participants will be included in a training program, as described below: 1º session will be robotic calibration and assessment; the following 18 sessions will be conducted the robotic therapy for upper limbs, three times a week. Each session will have a total duration of 55 minutes, including initial patient positioning and adjusting and after a sequence of game tasks.
干预措施: Robotic Therapy (Device)
结局指标
主要结局
Fugl Meyer Assessment Upper Limb (FMA-UL)
时间窗: Mean change from baseline at six weeks (19 sessions of robotic therapy).
FMA-UL evaluates the recovery of the hemiplegic patient after stroke. It includes the measurement of reflex activity, movement with and without synergy, voluntary movements and coordination of shoulder, elbow, wrist, hand.
次要结局
- Wolf Motor Function Test (WMFT)(Mean change from baseline at six weeks (19 sessions of robotic therapy).)
- Dynamometry - Grasp and Pinch(Mean change from baseline at six weeks (19 sessions of robotic therapy).)
- Patients safety(Adverse effects reported during 6 weeks treatment.)
- Treatment adherence(Drop outs reported during 6 weeks treatment.)