StrokePUAANCT04405609
Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Stroke Patients
A study testing ArmAssist in people with Stroke and Rehabilitation, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Rehabilitation, Upper Limb Rehabilitation
- What is being tested?
- ArmAssist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- 28 Oct 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects over 18,
- Upper limb hemiparesis after stroke,
- Unilateral paresis and cognitive ability to understand,
- Accept and actively participate in the usability study.
Who cannot join
- Bilateral motor deficit,
- Severe spasticity,
- Psychiatric illness,
- and/or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Acute, Subacute and Chronic 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.
- Conditions
- Stroke, Rehabilitation, Upper Limb Rehabilitation, Telerehabilitation, Robot-assisted Therapy
- Being tested
- ArmAssist
- Keywords
- Stroke, Cerebrovascular Disorders, Robotic
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ArmAssist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 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
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 3 weeks
Secondary outcomes (2)
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
Measured: 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.
Measured: Baseline, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start28 Oct 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- TECNALIA Research & Innovation, GMV Innovating Solutions
- Responsible party
- Sponsor
- Investigators
- Fernando Jesus Mayordomo Riera, MD, Principal investigator, Hospital Universitario Reina Sofia de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405609
- Sponsor's protocol ID
- ArmAssist 2.0
- Acronym
- PUAA
- Status last verified
- Jun 2020
- First submitted
- 19 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the collected information will be available for other researchers upon request.
Publications
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.
PubMed 33622344
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Acute, Subacute and Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT04405609
- Acronym / sponsor ID
- PUAA / ArmAssist 2.0
- Conditions
- Stroke, Rehabilitation, Upper Limb Rehabilitation, Telerehabilitation, Robot-assisted Therapy
- Keywords
- Stroke, Cerebrovascular Disorders, Robotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- TECNALIA Research & Innovation, GMV Innovating Solutions
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ArmAssist group | Experimental | Device: ArmAssistThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects over 18,
- Upper limb hemiparesis after stroke,
- Unilateral paresis and cognitive ability to understand,
- Accept and actively participate in the usability study.
Key exclusion criteria (4 listed)
- Bilateral motor deficit,
- Severe spasticity,
- Psychiatric illness,
- and/or cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArmAssistThe 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. | Device | ArmAssist group |
Primary outcome
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'
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
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'.
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.
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.
2 secondary outcomes
Fugl-Meyer Assessment (FMA) scale
Time frame: Baseline, 3 weeks
Modified Asworth Scale (MAS)
Time frame: Baseline, 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 33622344Guillen-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.
- Individual participant dataSharing planned: Yes. All the collected information will be available for other researchers upon request.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Jesus Mayordomo Riera, MD principal investigator
Hospital Universitario Reina Sofia de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArmAssist in people with Stroke and Rehabilitation, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale (time frame: Through study completion, an average of 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04405609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.