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

Not Applicable

Completed

• Conditions: Rehabilitation; Telerehabilitation; Stroke; Robot-assisted Therapy; Upper Limb Rehabilitation
• Interventions: Device: ArmAssist

• Registration Number: NCT04405609
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-28
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-28
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ArmAssist group	ArmAssist	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.

Primary Outcome Measures

Name	Time	Method
Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale	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	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	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	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	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 Outcome Measures

Name	Time	Method
Modified Asworth Scale (MAS)	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.
Fugl-Meyer Assessment (FMA) scale	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

Trial Locations

Locations (1)

Hospital Universitario Reina Sofía de Córdoba; 🇪🇸 Córdoba, Spain