Mobile Service Robot for Task-Oriented Stroke Therapy: User Evaluations

June 21, 2021 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Penn Medicine Rittenhouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Therapists with neuro-rehab experience. Patients with neural injury.

Description

Inclusion Criteria:

  • Certified rehabilitation healthcare professionals
  • Participants with upper extremity disabilities
  • Participant must be older than 18 years

Exclusion Criteria:

-Less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Focus groups- Patients
Subjects with or without an upper extremity disability will be asked to observe and interact with the mobile service robot.
Other: Mobile Service Robot Survey for Patients
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.
Focus Groups-clinicians
Clinicians with neuro-rehab experience.
Other: Mobile Service Robot Survey
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 1 week
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.
up to 1 week
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.
up to 1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Design requirements
Time Frame: up to 1 week
Design requirements measured by surveys administered to participants as well as by observation with the robot.
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle J Johnson, PhD, Penn Medicine Rittenhouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 819669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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