Effects of Robot-Assisted Therapy for Upper Limb Functional Recovery in Patients with Guillain-Barré Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)
研究概览
简要总结
Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually.
The aim of this double-blind randomized controlled trial with a SHAM control group is to evaluate the effects of robot-assisted therapy, integrated with conventional therapy, on upper limb motor recovery in patients with GBS.
详细描述
Guillain-Barré Syndrome is a leading cause of acute flaccid paralysis, presenting with limb weakness and hyporeflexia or areflexia. Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually. This study aims to assess the effectiveness of a robot-assisted rehabilitation treatment for upper limb motor recovery in patients with Guillain-Barré Syndrome. A double-blind randomized trial will be conducted, where the experimental group will undergo actual robotic rehabilitation sessions, while the control group will perform sessions in which the robot will carry out simple mobilization, comparable to traditional interventions. This approach will help maintain participant blinding. Patients will be evaluated before and after treatment, and with two follow-up assessments 60 and 90 days after therapy initiation. Evaluations will include muscle recruitment and autonomy in daily living activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Assessors, Patients and their caregivers will be blinded for the entire duration of the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Guillan-Barré Syndrome;
- •UL motor impairment (0-4 in the Medical Research Council scale);
- •sub-acute phase (until 180 days);
- •Patients able to maintain the sitting position.
排除标准
- •Concomitant neurological, orthopedic, metabolic, and oncological diseases;
- •Cognitive impairment assessed with the Mini Mental State Examination (score under 24 points);
- •Visual deficit;
- •Hearing disorders.
结局指标
主要结局
Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)
时间窗: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
THE FMAUE will be used to assess the change in the motor and sensory functions of the upper limb. The FMAUE included five domains: motor functioning, sensitivity, coordination, range of motion and pain. The score ranging from 0 to 66 points, a higher score corresponds to a better function of the upper limb.
次要结局
- The 36-Item Short-Form Health Survey (SF-36)(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- modified Barthel Index (mBI)(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- ABILHAND(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- The Medical Research Council scale (MRC)(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- The nine hole peg test (NHPG).(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- Grip strength(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)