StrokeNCT02779517
Mobile Service Robot for Task-Oriented Stroke Therapy: User Evaluations
An observational study of Stroke, run by University of Pennsylvania at 1 site in United States.
Trial summary
By developing an affordable mobile service robot for therapeutic activities in a health center environment, this project addresses the issue of both the high cost and man-power required to provide rehabilitation for stroke survivors and other patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Mobile Service Robot Survey and Mobile Service Robot Survey for Patients
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Therapists with neuro-rehab experience. Patients with neural injury.
Who may be able to join
- Certified rehabilitation healthcare professionals
- Participants with upper extremity disabilities
- Participant must be older than 18 years
Who cannot join
- -Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
About this study
By developing an affordable mobile service robot for therapeutic activities in a health center environment, this project addresses the issue of both the high cost and man-power required to provide rehabilitation for stroke survivors and other patients. Our goal is to measure users - clinician and patient - responses to a telepresence robot, VGo, that has been modified with a humanoid torso robot, NAO, to facilitate remote communication between the patient and clinician, and to complete supervisory exercise coaching.
Read the detailed description
This is a short demonstration and survey study. Clinical staff and patients will be gathered together and our idea for the mobile service robot will discussed. A demonstration of the telepresence feature of the robots and the NAO robot greeting and helping them with simple exercises will follow (e.g., pick up and object that is handy and lift their hands over their heads). The approximately 30-minute demonstration part of the study will start with an introduction and explanation about the project and a short speech about the Rehabilitation and Robotics Lab. After the demonstration the oral consent will be read and surveys will be handed out to those study participants who agree to complete them; if necessary, the research team will assist the study participant with the survey. Surveys will then be collected, and the group will be thanked by the research team.
- Conditions
- Stroke
- Being tested
- Mobile Service Robot Survey, Mobile Service Robot Survey for Patients
- Keywords
- upper extremity, stroke, rehabilitation, robotics, telepresence, elderly, aged, Housing for the elderly, retirement, homes for the aged
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Service Robot SurveyOther
The goal is to build a low-cost mobile service robot that will focus on the simple, but key, repetitive, data-driven tasks that robots do well. Rather than attempt to create a robot helper that mimics humans, the goal is to free human caregivers from the time-consuming tasks that robots can accomplish with facility, thereby allowing humans to focus on tasks that humans do best (i.e. human contact).
Mobile Service Robot Survey for PatientsOther
The goal is to build a low-cost mobile service robot that will focus on the simple, but key, repetitive, data-driven tasks that robots do well. Rather than attempt to create a robot helper that mimics humans, the goal is to free human caregivers from the time-consuming tasks that robots can accomplish with facility, thereby allowing humans to focus on tasks that humans do best (i.e. human contact). This survey differs in terms of design questions.
| Study group | Role | What they receive |
|---|---|---|
| Focus groups- Patients | Subjects with or without an upper extremity disability will be asked to observe and interact with the mobile service robot. Receives: Other: Mobile Service Robot Survey for Patients | |
| Focus Groups-clinicians | Clinicians with neuro-rehab experience. Receives: Other: Mobile Service Robot Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of the interaction with the robot
Perception of the robot measured by surveys administered to participants as well as by observation with the robot.
Measured: up to 1 week
Usability of the robot
Portability, ease of set up, cost, and appearance measured by surveys administered to participants as well as by observation with the robot.
Measured: up to 1 week
Sociability with the robot
Sociability of robot measured by surveys administered to participants as well as by observation with the robot.
Measured: up to 1 week
Secondary outcomes (1)
Design requirements
Design requirements measured by surveys administered to participants as well as by observation with the robot.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionDec 2016
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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle J Johnson, PhD, Principal investigator, Penn Medicine Rittenhouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779517
- Sponsor's protocol ID
- 819669
- Status last verified
- Jun 2021
- First submitted
- 31 Mar 2016
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wilk R. and Johnson MJ. 5th IEEE RAS/EMBS International Conference on Biomedical Robotics and Biomechatronics. ; 08/2014. doi:10.1109/BIOROB.2014.6913816
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Service Robot for Task-Oriented Stroke Therapy: User Evaluations
- ClinicalTrials.gov ID
- NCT02779517
- Acronym / sponsor ID
- 819669
- Conditions
- Stroke
- Keywords
- upper extremity, stroke, rehabilitation, robotics, telepresence, elderly, aged, Housing for the elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 May 2016 (estimated)
- 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.
By developing an affordable mobile service robot for therapeutic activities in a health center environment, this project addresses the issue of both the high cost and man-power required to provide rehabilitation for stroke survivors and other patients. Our goal is to measure users - clinician and patient - responses to a telepresence robot, VGo, that has been modified with a humanoid torso robot, NAO, to facilitate remote communication between the patient and clinician, and to complete supervisory exercise coaching.
Detailed description
This is a short demonstration and survey study. Clinical staff and patients will be gathered together and our idea for the mobile service robot will discussed. A demonstration of the telepresence feature of the robots and the NAO robot greeting and helping them with simple exercises will follow (e.g., pick up and object that is handy and lift their hands over their heads). The approximately 30-minute demonstration part of the study will start with an introduction and explanation about the project and a short speech about the Rehabilitation and Robotics Lab. After the demonstration the oral consent will be read and surveys will be handed out to those study participants who agree to complete them; if necessary, the research team will assist the study participant with the survey. Surveys will then be collected, and the group will be thanked by the research team.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus groups- Patients | – | Other: Mobile Service Robot Survey for PatientsSubjects with or without an upper extremity disability will be asked to observe and interact with the mobile service robot. |
| Focus Groups-clinicians | – | Other: Mobile Service Robot SurveyClinicians with neuro-rehab experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Therapists with neuro-rehab experience. Patients with neural injury.
Key inclusion criteria (3 listed)
- Certified rehabilitation healthcare professionals
- Participants with upper extremity disabilities
- Participant must be older than 18 years
Key exclusion criteria (1 listed)
- -Less than 18 years of age
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 |
|---|---|---|
| Mobile Service Robot SurveyThe goal is to build a low-cost mobile service robot that will focus on the simple, but key, repetitive, data-driven tasks that robots do well. Rather than attempt to create a robot helper that mimics humans, the goal is to free human caregivers from the time-consuming tasks that robots can accomplish with facility, thereby allowing humans to focus on tasks that humans do best (i.e. human contact). | Other | Focus Groups-clinicians |
| Mobile Service Robot Survey for PatientsThe goal is to build a low-cost mobile service robot that will focus on the simple, but key, repetitive, data-driven tasks that robots do well. Rather than attempt to create a robot helper that mimics humans, the goal is to free human caregivers from the time-consuming tasks that robots can accomplish with facility, thereby allowing humans to focus on tasks that humans do best (i.e. human contact). This survey differs in terms of design questions. | Other | Focus groups- Patients |
Primary outcome
Perception of the interaction with the robot
Time frame: up to 1 week
Perception of the robot measured by surveys administered to participants as well as by observation with the robot.
Usability of the robot
Time frame: up to 1 week
Portability, ease of set up, cost, and appearance measured by surveys administered to participants as well as by observation with the robot.
Sociability with the robot
Time frame: up to 1 week
Sociability of robot measured by surveys administered to participants as well as by observation with the robot.
1 secondary outcome
Design requirements
Time frame: up to 1 week
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 23 Jun 2021.
- BackgroundWilk R. and Johnson MJ. 5th IEEE RAS/EMBS International Conference on Biomedical Robotics and Biomechatronics. ; 08/2014. doi:10.1109/BIOROB.2014.6913816
- Individual participant dataSharing planned: No
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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.
Michelle J Johnson, PhD principal investigator
Penn Medicine Rittenhouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Pennsylvania at 1 site in United States.
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 3 inclusion and 1 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 23 Jun 2021. 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 United States. 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?
Perception of the interaction with the robot (time frame: up to 1 week). The study lists 3 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 NCT02779517, 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 23 Jun 2021.