Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Stroke Patients (PUAA)

June 1, 2020 updated by: Maimónides Biomedical Research Institute of Córdoba

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofía de Córdoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ArmAssist group

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

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:

  1. First phase: 5 weeks.
  2. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'
Through study completion, an average of 3 weeks
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
Through study completion, an average of 3 weeks
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'.
Through study completion, an average of 3 weeks
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.
Through study completion, an average of 3 weeks
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.
Through study completion, an average of 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment (FMA) scale
Time Frame: Baseline, 3 weeks
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)
Time Frame: Baseline, 3 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Collaborators

TECNALIA Research & Innovation
GMV Innovating Solutions

Investigators

  • Principal Investigator: Fernando Jesus Mayordomo Riera, MD, Hospital Universitario Reina Sofía de Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ArmAssist 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All the collected information will be available for other researchers upon request.

IPD Sharing Time Frame

Up to 12 months after trials publication.

IPD Sharing Access Criteria

Request by e-mail to uicec@imibic.org

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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