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临床试验/NCT03406754
NCT03406754Unknown不适用

Multi-disciplinary Rehabilitation Program for Advanced Parkinson's Patients in the Community

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Immediate change in gait speed

研究概览

简要总结

The present study examines the effectiveness of the rehabilitation program in the framework of the "Ezra LeMarpeh" project for Parkinson's patients. The Ezra LeMarpeh Association, founded by Rabbi A. E. Firer, provides assistance to the sick and needy. The site features a wide range of advanced, high quality rehabilitation devices, a unique hydrotherapy pool and associated accessories that enable the staff to provide the finest quality and most professional treatment. Before entering a rehabilitative program, each participant will arrive independently at the Ezra LeMarpeh Center for evaluation tests and will undergo comprehensive evaluation tests by the center's physiotherapist, including walking tests, balance tests, filling out questionnaires to assess Quality of life and disease severity. At the end of the program, the participants will be asked to repeat evaluation tests.

详细描述

Before entering a rehabilitation program, each participant will arrive independently at the "Ezra LeMarpeh" Center, at 24 Chida St., Bnei Brak. After a detailed explanation of the nature of the study, the participants will sign an informed consent form. The center's physiotherapists will test walking abilities, motor functioning and abilities in activities of daily living (ADL).

Walking tests can include walking at a comfortable pace, walking while counting (dual tasking), walking at different speeds and more. The balance tests include standing on a small base, standing on one leg, standing with eyes closed, and more. During the tests participants will wear small, non-invasive sensors at the wrists, ankles, and lower back. These sensors include an accelerometers and a gyroscopes that can be used to quantify gait measures, such as gait velocity, step length and variability. Lower back sensors will be worn continuously for up to a week for everyday activity.

At the end of the program, the participants will be asked to repeat evaluation tests.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of idiopathic Parkinson's disease, as defined in the UK Brain Bank criteria
  • Hoehn and Yahr stage I-III
  • Patients who are taking anti-Parkinson's drugs.
  • Participants who are in a stable medication regimen during the month preceding the study and are expected to remain in a permanent regime for the next 3 months.
  • Mini Mental State Exam (MMSE) score> 24
  • Able to walk independently for at least 5 minutes with or without support.

排除标准

  • Any neurological condition other than PD or orthopedic disease (eg after a stroke with neurological signs, MSA, Parkinsonism, PSP, etc.) that may impair normal walking and balance.
  • Significant cognitive impairment MMSE score<24
  • Any medical, surgical, and / or psychiatric condition which, in the opinion of the investigator, prevents the patient from completing all aspects of the research.

结局指标

主要结局

Immediate change in gait speed

时间窗: Immediate at the end of the program (8 weeks)

Gait speed will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.

Community ambulation

时间窗: Immediate at the end of the program (8 weeks)

Will be assessed using a body-worn small lightweight device (AX3 - continuous logging accelerometer) that will be worn by the subjects for 7 days to monitor ADL.

次要结局

  • Improve in motor function(Immediate at the end of the program (8 weeks))
  • Motor function(Immediate at the end of the program (8 weeks))

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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