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

Stroke Clinical Trial

— PUAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405609
• Other study ID #: ArmAssist 2.0
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2020
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rehabilitation
• Robot-assisted Therapy
• Stroke
• Telerehabilitation
• Upper Limb Rehabilitation

Intervention

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: 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía de Córdoba	Córdoba

Sponsors (3)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	GMV Innovating Solutions, TECNALIA Research & Innovation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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