Usability Study of ArmAssist 2.0. Robot: Homecare Arm Rehabilitation in Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study is to validate the usability of ArmAssist medical device, a robotic system for the rehabilitation of upper limbs in stroke patients (based on serious games). This study evaluate the usability of the system in a home environment, taking into account the ease-to-use, consistency and others; and will pretend demonstrate the feasibility of including or no, robotic therapy in home like complement of daily rehabilitation program. Finally this study investigate the acceptance from patients and therapists.

Official Title
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Usability Study of ArmAssist 2.0. Robot: Homecare Arm Rehabilitation in Acute, Subacute and Chronic Stroke Patients

Conditions
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Stroke, Rehabilitation, Upper Limb Rehabilitation, Telerehabilitation, Robot-assisted Therapy

Intervention / Treatment
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* Device: ArmAssist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects over 18, Upper limb hemiparesis after stroke, Unilateral paresis and cognitive ability to understand, Accept and actively participate in the usability study. Exclusion Criteria: Bilateral motor deficit, Severe spasticity, Psychiatric illness, and/or cognitive impairment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ArmAssist group<br>The post-stroke patients who participate in the study, are classified in differents stages (3 patients in each stage). Group 1: subacute, between 2 - 6 months Group 2: chronic of short evolution, between 6 - 12 months Group 3: long-term chronic, more than 12 months. The system is tested in a clinical (training) and patients' home setting. The ArmAssist system includes the ArmAsist 2.0 device (without motors), the tele rehabilitation platform based on serious games and Antari's HomeCare tele-care platform for the clinicians. | Device: ArmAssist<br>* The usability study protocol include 3 ArmAssist systems (2 designed for the left hand and one for the right hand) that could not be used in parallel because the aim of the study was to bring the systems to the home environment during part of the evaluation. The usability study is carried out in two phases: First phase: 5 weeks. Second phase: 3 weeks. Each phase included a week of training at the Hospital or IMIBIC facilities with a physiotherapist, and then 2 weeks at the patient's home, being the first one with the physiotherapist supervision and the second one by their own with the possibility of physiotherapist remote support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale | The purpose of this scale is to evaluate how satisfied the patient are with the assistive device and the related services they experienced. It consists of twelve questions, eight related to the device and four related to services of 12 satisfaction items with answers from 1 'Not satisfied at all' to 5 'Very satisfied' | Through study completion, an average of 3 weeks | 
| System Usability Scale: SUS | This scale provides a quick, reliable tool for measuring the usability. It consists of 10 item questionnaire and answers from 1 'strongly agree' to 5 'strongly disagree'. Scores are ranging to 0-100 %, where a high score means better usability with a higher score meaning better usability | Through study completion, an average of 3 weeks | 
| Intrinsic Motivation Inventory: IMI | This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'. | Through study completion, an average of 3 weeks | 
| Usability questionnaire specifically designed for the use of ArmAssist 2.0 | It consists of a 19 item questionnaire with seven response options (Likert sacle) for respondents; from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients and therapist with the system and the therapy. | Through study completion, an average of 3 weeks | 
| Structured interviews: Willingness-to-pay questionnaire | This interview consists in two short questions to ask to participants about the willingness-to-pay for ArmAssist 2.0. system as therapy. | Through study completion, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (FMA) scale | It is an index to assess the sensorimotor impairment in individuals who have had stroke. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximun score is 66 points | Baseline, 3 weeks | 
| Modified Asworth Scale (MAS) | This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension. | Baseline, 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic, Stroke, Cerebrovascular Disorders