The Use of AMADEO in Hand Rehabilitation in Patients With Parkinson Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Nine hole peg test
研究概览
简要总结
Hand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to functional disability and difficulties in activities of daily living. AMADEO®. is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.Aim of this study is to evaluate the efficacy of the end-effector finger system, AMADEO®, on hand-finger movements in PD patients evaluating the improvement on finger tapping and agility of hand movement item scores on the MDS-UPDRS, variation on the active finger strengths and the active and passive Range of Motion (ROM); variation on Electromyographic (EMG)-parameters.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic PD diagnosed according to the Gelb's criteria;
- •Hoehn-Yahr stage 1- 3
- •"On" state
- •MMSE score ≥ 24
- •Willing and able to give written informed consent;
- •Willing and able to comply with the study procedures.
排除标准
- •A specific kind of fluctuation: Sudden on-off fluctuations
- •History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms;
- •History of stereotaxic brain surgery for PD;
- •Mini-mental examination (MMSE) score less than 24 at screening;
- •Changes in Levodopa (DA) dose in any time within 4 week prior to baseline;
- •Changes in Dopamine Agonists (DA) in any formulation in any time within 4 week prior to baseline;
- •Presence of severe dyskinesia prior to baseline;
- •Any other medical or psychiatric condition that may compromise the patient's participation in this study;
研究组 & 干预措施
AMADEO Training
Twenty PD patients with hand bradykinesia will be treated with the AMADEO® system. They will undergo 15 training sessions, 5 a week for 3 weeks, each session lasting about 60 minutes. During each session, both the hands will be treated using the endeffector in its active and active-assisted modality.
干预措施: Training (Other)
AMADEO Training
Twenty PD patients with hand bradykinesia will be treated with the AMADEO® system. They will undergo 15 training sessions, 5 a week for 3 weeks, each session lasting about 60 minutes. During each session, both the hands will be treated using the endeffector in its active and active-assisted modality.
干预措施: AMADEO (Device)
OT training
Twenty control subjects (PD patients) will be treated with traditional rehabilitation focused on fine hand-finger movement skills. The patients in this group will undergo the same amount of treatment.
Both the groups will be trained with conventional physiotherapy concerning postural, balance and gait.
干预措施: OT Training (Other)
结局指标
主要结局
Nine hole peg test
时间窗: 1 month
9HPT is used to measure finger dexterity in patients with various neurological diagnoses
次要结局
- Bipolar surface electromyography(1 month)
研究者
Rocco Salvatore Calabrò
Medical Director, Neurologist
IRCCS Centro Neurolesi Bonino Pulejo