Action Observation Training for Upper Limb Recovery in Patients With Stroke: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment Upper Extremity
研究概览
简要总结
Background: Due to the complexity of the interventions in recovering the upper limb, at the moment there is a lack of evidence about the efficacy of rehabilitative interventions. Action Observation Training (AOT) constitutes a promising rehabilitative method to improve upper limb motor recovery in stroke patients.
Objective: The aim of the present study was to evaluate the effect of AOT both on upper limb recovery and on functional outcome when compared to patients treated with the task oriented training (TOT). Both treatments were added to traditional rehabilitative treatment.
详细描述
Participants Sample of 32 patients with stroke, randomly allocated in the experimental group (EG) or in the control group (CG).
Each participant underwent clinical assessments at Day 0 (the first day of treatment) and at the T1 time (last day of treatment after four weeks).
All assessment tools were performed by trained researchers not involved in the treatment administration.
All subjects underwent rehabilitative treatment for 4 consecutive weeks, 5 days per week. Each session consisted of 60 minutes of conventional treatment per day and, in addition, thirty minutes of Action Observation Training for the experimental group, or thirty minutes of Task Oriented Training for the control group.
Clinical scales
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Both gender
- •First ever stroke
- •Unilateral cerebral lesion
- •Onset of cerebrovascular pathology for a maximum of 30 days
- •Age between 18 and 90 years
- •Any schooling
- •Preserved ability to understand (Token Test score higher than 8)
- •Signature of consent by the patient and/or care giver.
排除标准
- •Posterior circulation infarction
- •Bilateral cerebral lesions
- •Subarachnoid hemorrhage
- •Severe unilateral spatial negligence (documented by a BIT star cancellation test score below 51)
- •Presence of ideo-motor apraxia as documented by a score < 53 in De Renzi's test
- •Cognitive impairment (MMSE score below
- •Severe visual impairment (documented by NIHSS field of vision examination)
- •Failure of the patient and/or care-giver to sign consent
- •Documented Alcohol and/or drug abuse
结局指标
主要结局
Fugl-Meyer Assessment Upper Extremity
时间窗: The first day of treatment - The last day of treatment after four weeks
the scale, which has good psychometric properties, is a quantitative measure of motor impairment in post stroke hemiplegic patients. Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = partially performs; 2 = fully performs). The upper limb section (FMA-UE) includes shoulder, elbow, wrist flexion and extension cooperative movement, wrist joint stability, coordination ability, and speed of small joint movement. The four domains assessed include motor function, sensation, passive joint motion, and joint pain. For this study we only used the motor function subscale. The total score of FMA-UE motor function range from 0 to 66.
次要结局
- Box and Block Test(The first day of treatment - The last day of treatment after four weeks)
- Functional Independence Measure(The first day of treatment - The last day of treatment after four weeks)
- Modified Ashworth Scale(The first day of treatment - The last day of treatment after four weeks)
研究者
Mauro Mancuso - Azienda USL Toscana Sud Est
Director of Physical and Rehabilitative Medicine Unit
Azienda USL Toscana Sud Est