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临床试验/NCT03015714
NCT03015714已完成不适用

Effectiveness of Aquatic Therapy for Parkinson's Disease Patients in the Context of a Multidisciplinary, Intensive Rehabilitation Treatment

Ospedale Generale Di Zona Moriggia-Pelascini1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Freezing of Gait Questionnaire (FOGQ)

研究概览

简要总结

Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation treatment.

详细描述

Freezing of gait (FoG) is an often dramatic, disabling episodic gait pattern that is common in Parkinson's disease (PD). FoG highly impairs mobility, causes falls, and reduces quality of life. Given the limited effectiveness of both the dopaminergic therapy and the deep brain stimulation on this symptom, it represents a challenge in the field of rehabilitation. In the last years, some studies described the effectiveness of aquatic therapy on balance dysfunction in patients with PD, correlating it to the safe conditions offered by the aquatic environment and to the physical properties of water. Nevertheless, the issues concerning the feasibility and the effectiveness of aquatic therapy for the treatment of FoG have never been addressed before. The aquatic environment may act on the sensorial peripheral receptors, thus widely stimulating the proprioceptive system. PD patients show an altered processing of the proprioceptive information that could potentially underline FoG. The investigators aim at investigating the effects of aquatic therapy for the treatment of FoG in PD patients undergoing a Multidisciplinary Intensive Rehabilitation Treatment (MIRT), whose effectiveness on several motor and functional parameters has been already demonstrated.

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 (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of PD according to Gelb et al;
  • •Hoehn & Yahr (H&Y) stage 2.5-3;
  • •Presence of FOG confirmed in the patient assessment prior to participation in the study;
  • •Stable pharmacological treatment for the last 8 weeks and during the rehabilitation period;
  • •Mini Mental State Examination (MMSE) ≥ 24;

排除标准

  • •Cardiac, pulmonary, vestibular and orthopedic diseases;
  • •Urinary incontinence;
  • •Severe dyskinesias;
  • •Patients treated with deep brain stimulation;
  • •Visual deficits;
  • •Comorbilities other than PD determining reduction of motor autonomy

研究组 & 干预措施

MIRT

Active Comparator

Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT).

干预措施: MIRT (Other)

MIRT-AT

Active Comparator

Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment associated with Aquatic Therapy (MIRT-AT).

干预措施: MIRT-AT (Other)

结局指标

主要结局

Freezing of Gait Questionnaire (FOGQ)

时间窗: 4 weeks

Assess FoG frequency, disturbances in gait and relationship to clinical features conceptually associated with gait and motor aspects.

次要结局

  • Six Minutes Walking Test (6MWT)(4 weeks)
  • Timed Up and Go Test (TUG)(4 weeks)
  • Unified Parkinson's Disease Rating Scale tot (UPDRS tot)(4 weeks)
  • Unified Parkinson's Disease Rating Scale Part III (UPDRS III)(4 weeks)
  • Unified Parkinson's Disease Rating Scale Part II (UPDRS II)(4 weeks)
  • Berg Balance Scale (BBS)(4 weeks)

研究者

发起方
Ospedale Generale Di Zona Moriggia-Pelascini
申办方类型
Other
责任方
Sponsor

研究点 (1)

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