Upper Limb Rehabilitation Using Armeo Spring in Patients With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- UPDRS rating scale- Section III
研究概览
简要总结
It has been shown that robot-assisted therapy may be considered an effective and reliable method for the delivery of highly repetitive training useful to boost neuroplasticity. Thus, an early, intensive, repetitive and task oriented training could be an ideal strategy to facilitate relearning of motor function and to improve motor function. The ARMEO-S® is a specific upper limb electromedical device mainly used to reduce spasticity and improve muscle force. To date robotic upper limb training has been applied only in patiebts with brain injury and spinal cord lesions.
Aim of the study is to evaluate the efficacy of ARMEO-S in improving upper limb agility in a sample of PD patients, as compared to traditional physiotherapy.
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 (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic PD diagnosed according to the UK BRAIN BANK criteria
- •Hoehn-Yahr stage 2- 3
- •MMSE score ≥ 23
排除标准
- •Severe Dyskinesia
- •On-Off Motor fluctuations
- •History of stereotaxic brain surgery for PD;
- •Changes in dopamine therapy dose in any time within 3 months prior to baseline;
- •Any other medical that may compromise the patient's participation in this study such as history of ostheoarthritis or neuropathies.
研究组 & 干预措施
Robotic Treatment
Fifteen patients with Parkinson's Disease will perform ten 45-minutes training sessions of the upper limb using the Armeo®Spring applied bilaterally, an electromedical device aimed at improving force and coordination in neurologically affected patients.
The device was built to sustain the forearm during the upper limb training and it is equipped with a VR screen with which the patient may interact during the playful and motivating rehab.
干预措施: Robotic Rehabilitation (Device)
Conventional Treatment
Fifteen patients with Parkinson's Disease will undergo ten 45-minutes training sessions of the upper limb with a traditional approach, performing the same excercises of the experimental group, i.e. flexo-extension of the wrist, prono-supination of the forearm, etcc.
干预措施: Robotic Rehabilitation (Device)
结局指标
主要结局
UPDRS rating scale- Section III
时间窗: 2 months
To assess whether PD patients may got better results in the motor part of the UPDRS after the UL training
Nine hole peg test
时间窗: 2 months
To evaluate if the patients will get better dexterity after the robotic training
次要结局
- Upper Limb Fugl-Mayer(2 months)
研究者
Rocco Salvatore Calabrò
Professor
IRCCS Centro Neurolesi "Bonino-Pulejo"