Skip to main content
OpenTrials
Completed

NCT Number: NCT04405609

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Rehabilitation Robot-assisted Therapy Telerehabilitation Upper Limb Rehabilitation Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Reina Sofía de Córdoba

Córdoba, 14004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ArmAssist

Device

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.

Primary outcomes

  1. 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'

  2. 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

  3. 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'.

  4. 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.

  5. 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

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Collaborators

  • GMV Innovating Solutions
  • TECNALIA Research & Innovation

Registry information

Official study title

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

Acronym: PUAA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 28, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.