Impact of Mézières Rehabilitative Method in Patients With Parkinson's Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change of Berg Balance Scale (BBS) from baseline to 12 weeks
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of a rehabilitative approach using breathing and relaxation techniques, and specifically the elongation of the latissimus dorsi muscle according to the Mézières Method to improve balance and posture and relief pain in patients with Parkinson's disease.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis od idiopathic Parkinson's disease (according to UK Brain Bank Criteria), Hoehn-Yahr stage ≤3 (determined during "on phase"), Mini Mental State Examination (MMSE) > or = 27, no rehabilitation treatment carried out within 3 months prior to the study, diagnosis of Parkinson's disease by at least 5 years.
排除标准
- •Dyskinesias
- •Severe fluctuations "on-off"
- •Modifications of anti-Parkinsonian drug therapy during the three months prior to the start of the study)
- •Sensitivity deficit of the trunk or lower extremities (physical examination)
- •Vestibular disorders or paroxysmal vertigo
- •Previous thoracic or abdominal surgery
- •Other neurological or orthopedic conditions involving the trunk or lower extremities (musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, prosthetic surgery)
- •Cardiovascular comorbidities (recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)
研究组 & 干预措施
Mézières Method group
Sessions of exercises for the recovery of midline symmetry, diaphragmatic breathing exercises, stretching of the latissimus dorsi respecting the global elongation according to the Mézières Method.
干预措施: Mézières Method (Other)
Home based exercise program group
Sessions of home based exercises performed by the patients at their domicile after a training session about the exercise program made by a physiotherapy. The exercises aimed at promoting trunk control in static and dynamic position according to the specific guidelines for Parkinson's disease and proprioceptive exercises for the recovery of balance. An illustrated exercises booklet was given to the patient.
干预措施: Home based exercise program (Other)
结局指标
主要结局
Change of Berg Balance Scale (BBS) from baseline to 12 weeks
时间窗: Baseline, 4 weeks, 12 weeks
It is a widely used clinical tests to evaluate static and dynamic balance of a subject. The total score is 56 (\> 45 safe walking without aids/low tendency to fall, \> 35 safe walking with aids). The test lasts 15-20 minutes, and includes 14 simple tasks. The success in achieving each task is evaluated assigned a score from zero (dependent) to four (independent), and the final measure is the sum of all scores. The scale is considered the gold standard for providing useful information on the predictive estimation of the risk of falls.
次要结局
- Change of Clinical Evaluation of Posture from baseline to 12 weeks(Baseline, 4 weeks, 12 weeks)
- Change of Visual Analogue Scale (VAS) from baseline to 12 weeks(Baseline, 4 weeks, 12 weeks)
- Change of Functional Gait Assessment (FGA) from baseline to 12 weeks(Baseline, 4 weeks, 12 weeks)
- Change of Modified Parkinson Activity Scale (MPAS) from baseline to 12 weeks(Baseline, 4 weeks, 12 weeks)
- Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks(Baseline, 4 weeks, 12 weeks)
- Change of Unified Parkinson's Disease Rating Scale (UPDRS) from baseline to 12 weeks(Baseline, 4 weeks, 12 weeks)
研究者
Teresa Paolucci
Medical Director
University of Roma La Sapienza