Multi-center, Double-blind, Cross-over Randomized Study on the Use of the Medical Device "Gondola" for Motor Rehabilitation in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle
研究概览
简要总结
The purpose of this research study is to evaluate safety and effectiveness of the Automated Mechanical Peripheral Stimulation (AMPS) therapy given via the Gondola™ device to improving Gait and Gait Related Disorders in patients with Parkinson'disease (PD). Gondola® is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS); the therapy requires less than 2 minutes.
详细描述
The proposed project, through a randomized multicentric, placebo controlled double-blind crossover trial aimed at evaluating the effectiveness of AMPS Gondola therapy versus Sham Gondola therapy in PD subjects. 132 in/outpatients with PD will be recruited. Subjects will be randomized in 2 groups, one starting with AMPS treatment, the other with placebo treatment. At the end of the first cycle of 6 stimulations over a 3 weeks' time (AMPS or Sham), all subjects will undergo a washout period of minimum 6 weeks, then will undergo another equivalent treatment cycle (Sham or AMPS); a follow up valuation 14 days after the end of each treatment cycle will be performed.
This project is aimed at studying and documenting the effects of the AMPS treatment given to PD patients via the Gondola device in:
- Improving gait, reducing bradykinesia, treating Freezing of Gait symptom;
- Improving UPDRS II and III scores;
- Improving balance. Another goal of the study is to document the safety of the Gondola device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Trained professionals, not directly involved in the research treatment and blind to patients group allocation, will perform clinical assessments. All subjects will undergo inpatient rehabilitation consisting of a treatment cycles using the Gondola device, once effective (AMPS treatment) and once placebo (Sham treatment).
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically chronic and stable PD, confirmed according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBC);
- •Age 45 and older;
- •Hoehn & Yahr (H&Y) stage equal or higher than 2 in ON state;
- •Ability to walk autonomously or with minimal assistance for a 10 meters' distance in OFF state;
- •Antiparkinsonian treatment at a stable and optimized daily dosage during the 4 weeks prior to the study.
排除标准
- •Any advanced, severe or unstable disease other than PD, which may interfere with the primary and secondary study outcome evaluations (autonomic dysfunction, diabetes, renal or hepatic failure, neoplasia, balance and gait problems of other origin).
- •Cognitive impairment with MoCA < 18
- •Any peripheral neurological or musculoskeletal conditions that may alter balance and/or gait.
- •Severe lower limb injuries in the previous 6 months.
- •History of neurosurgery or orthopedic surgery.
- •History of epilepsy.
- •Any drug treatment not intended to treat PD that may alter cognitive and/or motor performance.
- •History of depression or other psychiatric disorders.
- •Severe obesity defined as a BMI greater than 35.
结局指标
主要结局
Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle
时间窗: through study completion, an average of 16 weeks
Study success will be defined by an: improvement in gait speed of no less than 0,06 m/s as follows: H0: DT treatment phase - DT Sham phase \< 0.06m/s v.s. Ha: DT treatment phase - DT Sham phase ≥ 0.06m/s Where: DT = VPost6 - VPre VPost 6= gait speed after 6 treatment stimulations (at the end of the treatment cycle) Vpre = gait speed before the 1st treatment stimulation (at the beginning of the treatment cycle)
次要结局
- Change in clinical evaluation in MDS-UPDRS(through study completion, an average of 16 weeks)
- Change in clinical evaluation of step speed(through study completion, an average of 16 weeks)
- Change in time in walking(through study completion, an average of 16 weeks)
- Change in clinical evaluation in FOG-Q(through study completion, an average of 16 weeks)