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临床试验/NCT06854978
NCT06854978招募中不适用

R3THA Rehabilitation Feasibility and Usability Study

Kessler Foundation1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Box and Blocks Test

研究概览

简要总结

The purpose of this study is to assess how the Rehabilitation Technologies for Hand and Arm (R3THA) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of R3THA as outpatient telerehabilitation administered by trained clinicians to individuals with stroke.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •must be between the ages of 20 and 80
  • •must have enough movement in my arms and hands to actively interact with the video games as determined by study staff
  • •must have internet access at home.
  • •must be comfortable performing basic functions on a computer, such as browsing the internet.
  • •must be able to sit without a loss of balance while performing activities with my arms and hands as determined by study staff.

排除标准

  • •Severe muscle spasms or stiffness (spasticity) in the affected upper limb that limits movement, as determined by study staff.
  • •Thinking problems or have difficulty following instructions 3) Unable to interact with an entire computer screen due to spatial neglect 4) Difficulty understanding words spoken to me (Receptive aphasia) 5) Any other disabling nervous system condition (besides stroke) that has caused residual weakness, impaired range of motion, or spasticity 6) Severe arthritis that limits hand and arm movements 7) Not independent in functional activities/mobility prior to stroke

研究组 & 干预措施

Stroke

Experimental

The study will enroll up to 10 participants with stroke who will be paired with trained therapists to receive R3THA telerehabilitation. The participants with stroke will participate in 7 training sessions. The training includes hand and arm exercises.

干预措施: RETHA (Other)

结局指标

主要结局

Box and Blocks Test

时间窗: 5 weeks

box and blocks test is standard measure for hand dexterity and hand-eye coordination

Action Research Arm Test

时间窗: 5 weeks

The standard assessment for functional performance in individuals with stroke

Kinematic Assessment

时间窗: 5 weeks

Kinematic assesment to measure range of motion of the hand and arm

System Usability Survey

时间窗: 5 weeks

System Usability Scale is a well-established standardized metric used to measure usability perception of computer interfaces and products.

Exergame Questionnaire

时间窗: 5 weeks

It is a questionnaire developed to assess qualitative performance of the device

Performance Survey

时间窗: 5 weeks

It is a qualitative questionnaire with interview aimed at gauging the feasibility of integrating R3THA into the daily routines of individual with stroke/end users.

Fugl-Meyer Assessment for Upper Extremity

时间窗: 5 weeks

A standard clinical measure to assess the level of motor impairment in individuals with stroke.

次要结局

  • Montreal Cognitive Assessment Test (MOCA)(1 week)

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kiran Karunakaran

Research Scientist

Kessler Foundation

研究点 (1)

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