"Evaluation Of ALBA® Device for Upper Extremity Motor Function In Adults (18-80 Years Old) With Hemiparesis Secondary To Acquired Brain Injury In Subacute And Chronic Phases"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Changes on the Fugl-Meyer test
研究概览
简要总结
As part of the rehabilitation techniques, robotic equipment has been introduced for the rehabilitation of the upper extremity with promising results. In this context, the ALBA® devise for the training of the upper extremity is used in this project. This randomized controlled trial will compare a control group (n=16) with an experimental group (n=16) of adults with hemiparesis secondary to an acquired brain lesion. A convenience sample of inpatient will be selected from Los Coihues clinic after concealing the inclusion and exclusion criteria. All participants will perform 45 minutes of training, 5 days a week, for 4 weeks, 20 sessions total. The control group will receive 100% conventional treatment while the experimental group will receive 20 minutes of conventional treatment associated with 25 minutes of ALBA® training. Assessments will be taken before training (t1), at 4 weeks (t2), and at 3 months (t3).
详细描述
This study aims to investigate the efficacy of occupational therapy for patients with upper limb disabilities, specifically utilizing the ALBA® device for training. Robotic equipment has been introduced as part of rehabilitation techniques for the upper extremity with promising results, and the ALBA® device is being used in this project to assess its effectiveness. A randomized controlled trial will be conducted, comparing a control group receiving conventional treatment and an experimental group receiving a combination of conventional treatment and ALBA® training. Participants will be adults with hemiparesis secondary to an acquired brain lesion, selected from a convenience sample of inpatients at Los Coihues clinic after concealing the inclusion and exclusion criteria.
All participants will perform 45 minutes of training, 5 days a week, for 4 weeks, totaling 20 sessions. The control group will receive 45 minutes of conventional treatment, consisting of four types of exercises, including supine and seated exercises, bimanual seated activity, and bipedal exercise. The experimental group will receive 20 minutes of conventional treatment associated with 25 minutes of supervised ALBA® training. The ALBA® training will involve customizing the device software to the patient's progress and adjusting the angles of inclination for exercises. Each session will feature a virtual assistant guiding patients through a sequence of exercises, including a brief practice period, two series of repetitions of different movements, and a free exercise. Rest periods of 2-3 minutes will be given between each series. Assessments will be taken before training (t1), at 4 weeks (t2), and at 3 months (t3) to evaluate the effectiveness of the two treatment methods. This study design allows for the evaluation of both short and long-term effects. Overall, this study aims to provide evidence for the effectiveness of the ALBA® device for the rehabilitation of upper extremities and contribute to the existing literature on the use of robotic equipment in occupational therapy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients of Los Coihues clinic Diagnosis of acquired brain injury. Cognitive capacity and language that allows understanding and following the therapist's instructions.
- •Trunk control. Subacute and chronic stage (up to 2 years post injury). Upper extremity paresis able to perform movements with eliminated gravity (modified MRC 2).
排除标准
- •Cardiovascular instability Visual or acoustic limitations. Severe hypertonia (≥3 Ashworth Scale). Upper extremity with passive joint limitation and/or traumatic injury. Neuropsychological alteration (global aphasia, severe attentional deficit, spatial perception alteration).
- •Moderate to severe cognitive-behavioral alterations that do not allow the understanding of instructions.
- •Severe alterations of consciousness. Deficit in cephalic control. Severe deficit in sedentary balance.
结局指标
主要结局
Changes on the Fugl-Meyer test
时间窗: Baseline (t1) and 30 days after (t2)
The Fugl-Meyer Test is a widely used clinical assessment tool for measuring motor recovery in patients with brain damage, especially after a stroke. The test consists of a series of motor activities designed to assess the patient's ability to perform specific movements, such as extending the arm, opening and closing the hand, and standing up from a chair. The movements are scored on a scale of 0 to 2, where 0 means the patient cannot perform the movement and 2 means the patient can perform the movement fully.
次要结局
- MRC(Baseline (t1))
- ACER-R(Baseline (t1))
- Ashworth(Baseline (t1))
- FIM(Baseline (t1) and 30 days after (t2))
- Test SF-36(Baseline (t1), 30 days after (t2) and at follow up (90 days))
- System Usability Scale(Post intervention (30 days))