An interventional study of ArmAssist in Stroke, Rehabilitation and Upper Limb Rehabilitation, sponsored by Maimónides Biomedical Research Institute of Córdoba. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Maimónides Biomedical Research Institute of Córdoba · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
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.
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'
Time frame: 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
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 3 weeks
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
Time frame: Baseline, 3 weeks
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.
Time frame: Baseline, 3 weeks
Plan to share: Yes — All the collected information will be available for other researchers upon request.
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Maimónides Biomedical Research Institute of Córdoba