Feasibility Evaluation of WEAR-IT (Wearable Assistive and Rehabilitation Robot Facilitating Intensive Telerehabilitation) for Hand Therapy After Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Primary Outcome measure 1: Adherence to prescribed therapy dose
研究概览
简要总结
The goal of this clinical trial is to understand whether a program of using a hand robot at home, supported by telerehabilitation, is feasible for people living with stroke. The study aims to answer the following questions:
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What is the extent that people living with stroke complete the prescribed therapy program? (adherence)
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Do people living with stroke continue to participate in the therapy program until follow-up? (retention)
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How acceptable and helpful is the hand robot to be use at the outpatient rehabilitation clinic and home via telerehabilitation for people living with stroke?
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How reliable and safe is the hand robot when used in clinical and home settings?
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What are the costs of delivering the hand robot program compared to providing the same amount of standard therapy without the hand robot? Researchers will also compare rehabilitation using the hand robot program to a dose-matched therapy program that does not use the robot.
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Intervention group: Participants will use the hand robot for 12 weeks, with follow-up intervention and assessments at 6 months.
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Control (comparator) group: Participants will receive the same amount of therapy over 12 weeks, but without the hand robot, followed by 6-month follow-up.
For both groups, researchers will record information about each participant's clinical recovery, their experience with the therapy process and the cost of care.
详细描述
The objective of this study is to examine the clinical, technical, and economic feasibility of the WEAR-IT program, a robotic glove-based telerehabilitation intervention, when delivered in outpatient rehabilitation clinics and home settings for individuals living with chronic hand function limitations following a stroke. This pilot, multi-site, single-blind (masked) feasibility study includes an embedded feasibility randomized controlled trial conducted at Sunnybrook - St. John's Rehab in Toronto and the Glenrose Rehabilitation Hospital in Edmonton, with a total sample of 44 persons with stroke and 44 caregivers. Participants will be randomized to either the intervention group, receiving 12 weeks of intensive hand therapy using the robotic glove and gaming interface (7 days per week, 2 hours per day) followed by a 6-month unsupervised home-based phase, or the control (comparator) group, receiving a dose-matched therapy program without the robotic glove over the same timeline. Feasibility will be evaluated through clinical study measures (recruitment and enrollment rates, adherence, retention, intervention delivery fidelity, workflow/process), clinical measures (M-TEI, FMA-UE, ARAT, COPM), technical indicators of reliability, safety, personalization, and maintenance needs, and economic measures related to personnel, space, equipment, and participant time and expenses. Assessments will be completed at baseline, weeks 4, 8, and 12, and at 2- and 6-month post-therapy follow-up points. Quantitative analysis will follow an intention-to-treat approach using repeated-measures ANOVA and descriptive costing, while qualitative data will undergo inductive thematic analysis to capture participant and therapist experiences and identify considerations for refining and scaling the intervention in a future large-scale trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
We will also mask the student researchers conducting data analysis, along with two of the four investigators (one at the Toronto site and one at the Edmonton site). Since the intervention involves technology, participants, caregivers, and care providers and research coordinators cannot be masked. The investigator who will oversees the study and randomization and the investigator responsible for providing technology training will also be unmasked.
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
- •Each participant must meet all of the following inclusion criteria to participate in this study:
- •A) Persons with chronic stroke:
- •Be able to attend one rehabilitation site (Toronto or Edmonton),
- •Be 18 years of age or older,
- •Be able to provide informed consent,
- •Has English language proficiency,
- •Be in the chronic stage of recovery (e.g., > 6 months post-stroke),
- •Have hand recovery at Stage 1 (flaccid paralysis) to Stage 4 (inability to make a fist and then extend the fingers fully) on the Chedoke-McMaster Stroke Assessment (CMSA)
- •Have a pain rating between 0/10 (no pain) and 4/10 (moderate pain) at rest and with assisted hand movement
- •Demonstrate the ability to understand and participate in a 3-month study program,
- •Live with someone or have someone consistently available (caregiver participant) who can help with setting up telerehabilitation equipment and assist with putting on/removing the Glove (as needed), and
- •Have access to a computer or tablet with a camera and a reliable internet connection for telerehabilitation sessions.
- •B) Caregiver participants who are willing to assist people living with stroke can be included if they meet the following criteria:
- •Be 18 years of age or older,
- •Be able to provide informed consent , and
- •Be able to support glove donning/doffing, set-up, and therapy for people living with stroke at home.
排除标准
- •All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
- •A) Persons with chronic stroke:
- •Have no limitations in fully extending fingers or making a fist,
- •Are experiencing pain or cognitive impairments that prevent active participation in therapy,
- •Be unable to communicate with therapists independently,
- •Have had any musculoskeletal or other neurological conditions that would impact their participation in a hand rehabilitation program, or
- •Are currently involved in another rehabilitation program aimed at improving upper limb movement.
研究组 & 干预措施
Intervention arm
The intervention arm will receive the hand-robot therapy program.
干预措施: Wearable Assistive and Rehabilitation robot facilitating Intensive Telerehabilitation Program (Device)
Comparator arm
The comparator arm will receive the non-hand robot therapy program.
干预措施: Dose-Matched Therapy Program (Other)
结局指标
主要结局
Primary Outcome measure 1: Adherence to prescribed therapy dose
时间窗: Week 1, week 4, 8, 12, 20, 36
Adherence will assess feasibility of the program by quantifying the extent to which participants complete the prescribed therapy dose (device usage log and therapist records) during the intervention period. Unit of Measure: Adherence (%) = 100 × (number of completed sessions ÷ prescribed sessions). Higher values indicate better program feasibility and implementation.
Primary Outcome Measure 2: Retention
时间窗: Week 1, week 4, 8, 12, 20, 36
Retention will assess feasibility by quantifying the proportion of participants who continue participation through scheduled sessions over follow-up. Unit of Measure: Retention (%) = 100 × (participants remaining in study/ participants enrolled). Higher values indicate greater feasibility and sustained engagement with the intervention.
次要结局
- Secondary Outcome Measure 1: Fugl-Meyer Assessment - Upper Extremity (FMA-UE) score(Week 0, week 4, 8, 12, 20, 36)
- Secondary Outcome Measure 2: Action Research Arm Test (ARAT) score(Week 0, week 4, 8, 12, 20, 36)
- Secondary Outcome Measure 3: Canadian Occupational Performance Measure (COPM) performance score(Week 0, week 4, 8, 12, 20, 36)
- Secondary Outcome Measure 4: Canadian Occupational Performance Measure (COPM) satisfaction score(Week 0, week 4, 8, 12, 20, 36)
- Secondary Outcome Measure 5: Intervention acceptability score(Week 1, week 4, 8, 12, 20, 36)
- Secondary Outcome Measure 6: Intervention delivery fidelity(Week 1, 4, 8, 12, 20, 36)
- Secondary Outcome Measure 7: Study feasibility-recruitment rate(Recruitment period)
- Secondary Outcome Measure 8: Study feasibility-enrollment rate(Screening to enrollment period)
- Secondary Outcome Measure 9: Study feasibility- process management(Week 1, 4, 8, 12, 20, 36)
- Secondary Outcome Measure 10: Technical feasibility-safety and adverse events(Week 1, 4, 8, 12, 20, 36)
- Secondary Outcome Measure 11: Technical feasibility-ongoing risk management(Week 1, 4, 8, 12, 20, 36)
- Secondary Outcome Measure12: Technical feasibility- Personalization requirements(Week 1, 4, 8, 12, 20, 36)
- Secondary Outcome Measure 13: Technical feasibility- design feedback and recommendations(Week 1, 4, 8, 12, 20, 36)
- Secondary Outcome Measure 14: Technical feasibility- data utility(Week 1, 4, 8, 12, 20, 36)
- Secondary Outcome Measure 15: Technology feasibility-maintenance(Week 1, 4, 8, 12, 20, 36)
- Secondary Outcome Measure 16: Economic feasibility-administrative cost(From enrollment to end of follow-up at week 36)
- Secondary Outcome Measure 17: Economic feasibility-therapeutic staff cost(Week 1, 4, 8, 12, 20, 36)
- Secondary Outcome Measure 18: Economic feasibility- participant cost(Week 1, 4, 8, 12, 20, 36)
研究者
Dr. Rosalie Wang
Affiliate Scientist
Sunnybrook Health Sciences Centre