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临床试验/NCT04232163
NCT04232163已完成不适用

Evaluation of a Program to Increase Upper Limb Recovery After Stroke

University of British Columbia14 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年8月15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
62
试验地点
14
主要终点
Hand counts captured using an activity monitor

研究概览

简要总结

This study will examine the feasibility and effect of a program that combines exercise and feedback from a wearable device on upper limb movement practice and function in individuals with stroke.

详细描述

Participants will be randomized into either the Immediate Treatment Group or the Delayed Treatment group. Both groups will complete the same intervention program. The Immediate treatment group will start the program right away while the Delayed Treatment group will start the program after a 3 week delay. The intervention program is 3 weeks in duration and consists of participants completing at least two hours of exercises (adapted from the Home-GRASP program) daily and wearing an activity monitor on their affected wrist during waking hours for the duration of the intervention. Participants will be asked to meet daily movement count goals based on information from the monitor. Participants will have 6 virtual sessions with a therapist who will teach and monitor exercises thru an online platform (Zoom Video Communications), work with participants to generate and progress daily movement goals and discuss barriers and potential solutions to exercise adherence and/or meeting movement goals.

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

入选标准

  • 19 years or older
  • < 1 year since the stroke occurred
  • Living in the community
  • Have unilateral upper limb impairment
  • Have some ability to move their arm and hand (> 30° shoulder flexion or abduction and Fugl Meyer finger extension score > 0)
  • Are using their affected upper limb in a different way than prior to their stroke (REACH score < 4)
  • Completed formal physical and occupational therapy rehabilitation for the upper limb
  • Have access to a tablet, computer, laptop or phone with internet and email access.
  • NOTE: If participant have a caregiver, we would like to invite him/her to assist in this study; however, a caregiver is not a must for participating in this study.

排除标准

  • musculoskeletal/other neurological conditions that limit movement in their arm
  • unable to provide informed consent
  • have another medical condition that would affect their ability to participate in the treatment protocol
  • have persistent pain in their affected upper limb that affects their ability to use the limb
  • Unable to speak, understand, or read English (unless another person, [i.e., family member, care taker or friend] can be present and translate during measurement/treatment sessions, and home activities related to the study

结局指标

主要结局

Hand counts captured using an activity monitor

时间窗: Post intervention (immediately following 3 weeks of intervention)

Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days

次要结局

  • ArmCAM (Arm Capacity and Movement Test)(Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention))
  • Stroke Impact Scale - hand and strength scales(Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention))
  • Hand count measured during the intervention sessions(Daily counts within 3 week intervention)
  • REACH Scale(Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention))
  • Hand counts captured using an activity monitor(Follow up (two months after completion of intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Janice Eng

Principal Investigator

University of British Columbia

研究点 (14)

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