跳至主要内容
临床试验/NCT03477695
NCT03477695Unknown不适用

Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Average trunk angle in the sagittal plane using a Postural Analysis Chart

研究概览

简要总结

A stooped posture is one of the characteristic motor symptoms of patients with Parkinson's disease, and has been linked to impairments in ADL and QOL. We aimed to test the efficacy, safety, practical utility and user-friendliness of a posture correction and vibrotactile trunk angle feedback device (the UpRight) in the home setting of patients with Parkinson's disease with a stooped posture.

详细描述

The subjects will be asked to arrive at the Gait laboratory for Mobility Research at Tel Aviv Medical Center. After a detailed explanation of the research procedure and after signing the consent form, they will be introduced to the UPRIGHT GO device. Participances will practice operating and placing the device on the body.

With the device attached to upper back, a number of short clinical tests will be performed:

  1. Complete demographic questionnaires and medical history

  2. Walking tests and balance:

  3. Short walks at a comfortable speed with or without dual task.

  4. Stairs

  5. Performing daily tasks, such as entering and exiting a room, negotiating obstacles (shoebox), walking between obstacles, buttons, tying laces, carrying small objects on a tray, bringing a glass of water etc.

  6. Timed "Get up and go test" All tests are supervised by a physiotherapist .

Upon completion of the tests, the UPRIGHT device will be delivered for use and exercise for 2 months. Physiotherapist will guide to maintain the devices (such as charging devices and connecting to power).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of Parkinson's disease, as defined in the UK Brain Bank criteria
  • •Hoehn and Yahr stage I-III
  • •Participants who are at stable medication regimen
  • •Able to walk independently for at least 5 minutes with or without support of accessory device.

排除标准

  • •Mini Mental State Exam (MMSE) score< 24

研究组 & 干预措施

Upright device

Experimental

Ambulatory use of the Upright device

干预措施: ambulatory use of the Upright device (Device)

结局指标

主要结局

Average trunk angle in the sagittal plane using a Postural Analysis Chart

时间窗: 8 weeks

Postural Analysis

次要结局

  • Patient satisfaction by VAS scores(8 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验