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临床试验/NCT04918342
NCT04918342已完成不适用

Comparison of Individualized Versus Group Telehealth Physical Therapy Programs for Individuals With Parkinson Disease

Ithaca College2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in "Mini-Balance Evaluation Systems Test" Score

研究概览

简要总结

This study will compare the impact of physical therapist led telehealth exercise programs on people with Parkinson disease. Eligible participants will complete this program individually or in a group of 9 other participants. The impact of participation in this program on motor function, postural control, gait, quality of life, and self-efficacy for exercise will be measured.

详细描述

This program will be delivered 2 times per week for 8 weeks with examination of outcome measures prior to and after completion. The investigators plan to enroll 20 participants with 10 completing a group program led by a physical therapist and 10 completing an individual exercise program led by a physical therapist.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • have a diagnosis of idiopathic Parkinson disease
  • been prescribed a stable dose of levadopa medication for at least 4 weeks prior to study participation
  • be able to walk independently
  • have a referral from a physician to participate in the program
  • have access to a computer/tablet/or phone to use for telehealth sessions with reliable internet and access to the Zoom platform

排除标准

  • have any other neurological condition other than Parkinson disease
  • have a score less than 20/28 on the Mini-Balance Systems Evaluation Test (reflecting a higher risk of falls)
  • demonstrate unstable/unsafe blood pressure or heart rate responses during the initial evaluation with response to submaximal exercise
  • have any musculoskeletal condition that affected their ability to participate in the exercise group
  • score less than 24/30 on the Mini Mental Status Examination during the initial evaluation

结局指标

主要结局

Change in "Mini-Balance Evaluation Systems Test" Score

时间窗: Prior to and after the 8 week intervention.

This is a 14 item outcome measure that examines postural control in standing. The measure includes items that assess anticipatory postural control, reactive postural control, somatosensory integration, and dynamic gait. The scores range from 0-28 points with 28 reflecting the best possible balance performance.

Change in "Five Times Sit to Stand" test time

时间窗: Prior to and after the 8 week intervention.

For this outcome the participant is asked to perform sitting to standing transitions 5 times as quickly as possible. The time to complete the task is recorded. A lower time is associated with faster and more agile performance with sitting to standing transitions.

次要结局

  • Change in 10 meter walk test(Prior to and after 8 week intervention.)
  • Change in Self Efficacy for Exercise Scale score(Prior to and after 8 week intervention.)
  • Change in Parkinson Disease Questionnaire-39 score(Prior to and after 8 week intervention.)
  • Change in Six Minute Walk Test Distance(Prior to and after 8 week intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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