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临床试验/NCT06730074
NCT06730074招募中不适用

A Novel Robotic System for Motor-cognitive Exercise for Patients With Parkinson's Disease

Adi Negev-Nahalat Eran1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
level of engagement

研究概览

简要总结

The objective of this study is to test a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD). This pilot experiment will involve the collection of both subjective user evaluation measures and objective motor and cognitive measures.

详细描述

Participants & Protocol:

Recruitment: Advertising ads in movement disorders units in hospitals and medical centers in the south, as well as through the help of the Parkinson's Association.

The study will be conducted with 15 PD patients, aged 50-75, at the Adi Negev Clinic. Each patient will use the robotic system five times, with each session lasting 30 minutes. The intervention plan incorporates principles of effective rehabilitation practice, including repeated practice, goal-oriented practice, variable difficulty, rhythmic cueing, and social interaction. Before the research begins, participants will sign an informed consent form.

Baseline and Pre-Post Tests:

Assessments including the MoCA, demographic data, clinical data, Color Trails Test (CTT), motor UPDRS, Box & Blocks Test, and Cognitive Reserve Index Questionnaire (CRIq) will be collected before the first session by an occupational or physical therapist. After the fifth session, post-intervention assessments will include motor UPDRS, Box & Blocks Test, CTT, System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI), and a satisfaction questionnaire.

研究设计

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

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signing the informed consent form
  • Men and women in ages 50-75
  • Hebrew speakers
  • Have Idiopathic Parkinson's disease
  • Hoehn and Yahr 3 and below
  • Moca test 23 and above

排除标准

  • Patients with Parkinson's plus syndromes
  • PD patients who suffer from unrelated neurological symptoms.
  • Orthopedic problems of the upper limb
  • Recent surgery conducted on the upper limb
  • Uncorrected vision problems
  • Uncorrected severe hearing loss

结局指标

主要结局

level of engagement

时间窗: 2 Mon

We will ask participants to rate their perceived level of engagement with the platform.

次要结局

  • improvement in UPDRS(4 Mon)
  • improvement in fine motor coordination(4 Mon)
  • improvement in CTT (Color Trail Test)(4 Mon)
  • Testing the usability of use of the system(4 Mon)
  • Measuring the motivation to use the system(4 Mon)

研究者

发起方
Adi Negev-Nahalat Eran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilanit Baum-Cohen

Occupational Therapist

Adi Negev-Nahalat Eran

研究点 (1)

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