NCT04405609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

May 19, 2020

Last Update Submit

June 1, 2020

Conditions

StrokeRehabilitationUpper Limb RehabilitationTelerehabilitationRobot-assisted Therapy

Keywords

StrokeCerebrovascular DisordersRobotic

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Fugl-Meyer Assessment (FMA) scale

    Baseline, 3 weeks

  • Modified Asworth Scale (MAS)

    Baseline, 3 weeks

Study Arms (1)

ArmAssist group

EXPERIMENTAL

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

Interventions

ArmAssistDEVICE

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.

ArmAssist group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects over 18,
  • Upper limb hemiparesis after stroke,
  • Unilateral paresis and cognitive ability to understand,
  • Accept and actively participate in the usability study.

You may not qualify if:

  • Bilateral motor deficit,
  • Severe spasticity,
  • Psychiatric illness,
  • and/or cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Reina Sofía de Córdoba

Córdoba, 14004, Spain

Location

Related Publications (1)

  • Guillen-Climent S, Garzo A, Munoz-Alcaraz MN, Casado-Adam P, Arcas-Ruiz-Ruano J, Mejias-Ruiz M, Mayordomo-Riera FJ. A usability study in patients with stroke using MERLIN, a robotic system based on serious games for upper limb rehabilitation in the home setting. J Neuroeng Rehabil. 2021 Feb 23;18(1):41. doi: 10.1186/s12984-021-00837-z.

    PMID: 33622344DERIVED

MeSH Terms

Conditions

StrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Fernando Jesus Mayordomo Riera, MD

    Hospital Universitario Reina Sofia de Córdoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 28, 2020

Study Start

October 28, 2019

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Up to 12 months after trials publication.
Access Criteria
Request by e-mail to uicec@imibic.org

Locations

ES(1)