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临床试验/NCT04363944
NCT04363944已完成不适用

A Functional Upper Limb Training and Assessment Tool to Enhance Efficacy and Scalability of Rehabilitation in Ecological Environments

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年2月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Repetitions Completed for Each Activity in the mRehab Home Program

研究概览

简要总结

Interventions promoting optimum motor performance across the lifespan are a priority after a neurological insult such as stroke. The proposed research incorporates smart devices and 3D printing to create a patient-centered rehabilitation device, mRehab. This innovative blend of technology and principles of neuroplasticity can advance standards of practice in healthcare. In this feasibility study, it is hypothesized that individuals with chronic stroke can successfully use the portable rehabilitation unit, mRehab, at home with minimal oversight from the research team. Use of mRehab in a home based setting and functional changes in upper limb movement will be assessed.

详细描述

Impairments following stroke make it one of the leading causes of disability. Many individuals with stroke do not recover complete function of the upper limb at time of discharge from clinical services. Moreover, early stage improvements may wane following the cessation of formal therapies. Regaining as much upper limb function as possible is important, as even mild impairments are associated with limitations in daily function and lower health-related quality of life. The overarching purpose of this project is to use portable technology, affordable for home use, to provide objective feedback on performance of upper limb motor tasks to individuals with residual deficits following chronic conditions such as stroke. Objective feedback serves to better inform the participant of their progress and actively engage them in their rehabilitation, thus encouraging self-management of rehabilitation. Results from a recent survey shows therapists predominantly provide patients with stroke written home exercise programs at time of discharge from therapies. With this static approach, patients have a limited capacity to evaluate their motor performance and no encouragement to refine their movement. Smartphones were coupled with three-dimensional (3D) printed objects to create a home rehabilitation system, mRehab. The built-in sensors in smartphones and a custom app can quantify characteristics of movement and provide actionable feedback to users during in-home rehabilitation. It was hypothesized that 1) participants with stroke could use mRehab in a home program with minimal oversight and 2) use of mRehab would result in changes in functional movement.

Methodology: A single-subject experimental design with multiple baselines was used. A strength of the single-subject study design is that participants serve as their own control. Each participant had a varying length of the baseline and follow-up periods to establish that the intervention, rather than time, was the primary reason for any observed change in performance. Participants completed baseline measurements, a six-week mRehab home program, and follow-up measurements. Baseline measurements consisted of both in-lab and in-home measurements. Participants attended two lab visits prior to starting the home program to establish baselines on clinical assessments and to learn how to use mRehab. MRehab collected limited preliminary performance data without providing feedback during baseline. Participants then used mRehab in a six week home program receiving feedback on their performance each time they completed practice of an activity. At the completion of the home program participants completed follow up assessments that were similar to the baseline measurements. In addition, usability of mRehab was assessed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Individuals in the intervention all had a history of stroke.
  • •Inclusion Criteria for feasibility study:
  • •at least 18 years of age and living in the community
  • •had a history of one stroke six or more months previous
  • •had a minimum score of 124 on the Mattis Dementia Rating Scale (MDRS).

排除标准

  • •for feasibility study:
  • •acute or chronic pain that would interfere with participation
  • •severely limited range of motion or contractures of shoulder, elbow, wrist or hand,
  • •absent or severely impaired proprioception of the upper limb
  • •musculoskeletal or circulatory conditions affecting the upper limb such as vascular disease, tendonitis, cellulitis, Raynaud's syndrome, or severe osteoarthritis or rheumatoid arthritis
  • •spasticity graded as 3 or greater for upper extremity movement on the Modified Ashworth Scale (MAS)
  • •botulinum toxin injections for spasticity management within three months of starting the study

研究组 & 干预措施

mRehab

Experimental

Use of mRehab in a home program completing unilateral and bilateral activities. Participants are able to complete unilateral activities with their paretic arm/hand

干预措施: mRehab (Device)

mRehab completing all activities bilaterally

Experimental

Use of mRehab in a home program completing unilateral and bilateral activities. Participantsare can only complete intended unilateral activities using both hands

干预措施: mRehab (Device)

结局指标

主要结局

Repetitions Completed for Each Activity in the mRehab Home Program

时间窗: 6 week in-home program

The total number of repetitions each participant completed for each activity in mRehab during the 6 week home program was recorded. The average total number of repetitions completed for each activity is reported.

Time to Complete Activity in the mRehab Home Program

时间窗: last day of the 6 week in home program

average time to complete an activity in the mRehab home program

Average Smoothness Per Activity in the mRehab Home Program

时间窗: last day of the 6 week in-home program

The average smoothness per activity in mRehab on the first day of the 6 week home program. Using the acceleration readings from the inertial measurement unit embedded in the smartphone, a normalized jerk score which is dimensionless, allowing comparisons of movements that vary in duration and/or amplitude, can be computed. There are no set upper bounds for the score, as it is dependent on the smoothness. The minimum score is 0, which would indicate no jerk, or perfectly smooth movement. This measurement provides relative information for each movement as a normal range has not been established for each of the movements in this study. Overall, a lower score indicates smoother movement.

次要结局

  • Wolf Motor Function Test(within 1 week of the completion of the in-home program)
  • mRehab Acceptance Questionnaire(within 1-3 weeks of completion of the 6 week in-home program)
  • Systems Usability Scale (SUS)(within 1-3 weeks of completion of home program)
  • Nine Hole Peg Test(within 1 week of the end of the in-home program)
  • Difficulty Rating Scale(within 1 - 3 weeks of the end of the program)

研究者

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

Jeanne Langan

Principal Investigator

State University of New York at Buffalo

研究点 (1)

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