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Clinical Trials/NCT04405609
NCT04405609
Completed
Not Applicable

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

Maimónides Biomedical Research Institute of Córdoba1 site in 1 country9 target enrollmentOctober 28, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Enrollment
9
Locations
1
Primary Endpoint
Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 28, 2019
End Date
December 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Maimónides Biomedical Research Institute of Córdoba
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale

Time Frame: Through study completion, an average of 3 weeks

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'

System Usability Scale: SUS

Time Frame: Through study completion, an average of 3 weeks

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

Usability questionnaire specifically designed for the use of ArmAssist 2.0

Time Frame: Through study completion, an average of 3 weeks

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.

Intrinsic Motivation Inventory: IMI

Time Frame: Through study completion, an average of 3 weeks

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'.

Structured interviews: Willingness-to-pay questionnaire

Time Frame: Through study completion, an average of 3 weeks

This interview consists in two short questions to ask to participants about the willingness-to-pay for ArmAssist 2.0. system as therapy.

Secondary Outcomes

  • Modified Asworth Scale (MAS)(Baseline, 3 weeks)
  • Fugl-Meyer Assessment (FMA) scale(Baseline, 3 weeks)

Study Sites (1)

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