StrokeBaxterNCT02806843
Robot-Assisted Stroke Rehabilitation Based on Patient-Therapist Interactions
A study testing Rehab InterCap system and 3D Kinect in people with Stroke and Hemiplegia, run by University of Pennsylvania at 1 site in United States.
Trial summary
Our study goal is to assess natural patient-therapist interactions in order to map such human-human activities to robot-human interactions. Critical to accomplishing this mapping will be determining the feasibility of a humanoid robot interacting with a patient in a more intuitive and flexible way, while concomitantly… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hemiplegia, Healthy
- What is being tested?
- Rehab InterCap system and 3D Kinect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke survivors 18 years of age with hemiplegia and varying levels of impairment
- Healthy subjects greater than 18 years of age with no motor disabilities
Who cannot join
- Under 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
Our study goal is to assess natural patient-therapist interactions in order to map such human-human activities to robot-human interactions. Critical to accomplishing this mapping will be determining the feasibility of a humanoid robot interacting with a patient in a more intuitive and flexible way, while concomitantly investigating the issue of safe contact and release.
Read the detailed description
Stroke survivors with varying levels of motor deficit impairment in their upper extremity (UE) will be assessed using standardized clinical scales for cognition and motor impairment. Following assessment, the patient and therapist will complete a therapy session consisting of activities of daily living (ADL).
During the therapy session, visual 3D motion tracking will be used via Kinect, audio will be recorded, and basic measurements (i.e. the distance between a participants wrist and elbow) will be taken. After the patient-therapist interaction has been mapped, members of the research team will build computer based models of the therapist and patient using the insights gained from the human-human interaction. The models developed in this proposed study will be used as a template for programming safe and intuitive humanoid-patient interactions for future study. The model of the therapist will be implemented on the Robot (w/o a patient involved) and in a simulation environment where it will be tested with a computer-based model of the patient.
- Conditions
- Stroke, Hemiplegia, Healthy
- Being tested
- Rehab InterCap system and 3D Kinect
- Keywords
- stroke, hemiplegia, healthy, robotics, rehabilitation, therapy
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehab InterCap system and 3D KinectDevice
The therapist will conduct a therapy session which will consist of various activities of daily living. During the session, the motion of the therapist and patients will be collected with a custom motion capture system (Rehab InterCap) and 3D visual mapping may take place using the Kinect device, audio will be recorded, and basic measurements of length (i.e. the distance from a participant's shoulder to elbow) will be taken. Patients and therapists will wear the sensors to capture their arm movements. 3D video motion capture may be completed with some subjects. This will involve subjects wearing reflective markers on their upper arms in addition to the intercap sensors.
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors and healthy subjects | Experimental | Stroke survivors greater than 18 years of age with hemiplegia and varying levels of impairment as well as healthy subjects greater than 18 years old with no motor disabilities will be asked to interact with a therapist. The Patient-Therapist interactions will be recorded using the Rehab Intercap System and 3D Kinect Device. Receives: Device: Rehab InterCap system and 3D Kinect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Therapist Interaction Mapping
Using the data collected during the subject's visit to the Rehabilitation Robotics Lab, computer-based models of the therapist and the patient will be devised.
These models may be used in future studies with a robot Video collection of patient-therapists in real settings.
Measured: 1 session, about 2 hours in length
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Study stopped due resource interruption.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
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
- NCT02806843
- Sponsor's protocol ID
- 820068
- Acronym
- Baxter
- Status last verified
- Jan 2024
- First submitted
- 16 Jun 2016
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Stroke Rehabilitation Based on Patient-Therapist Interactions
- ClinicalTrials.gov ID
- NCT02806843
- Acronym / sponsor ID
- Baxter / 820068
- Conditions
- Stroke, Hemiplegia, Healthy
- Keywords
- stroke, hemiplegia, healthy, robotics, rehabilitation, therapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study stopped due resource interruption.
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jun 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.
Our study goal is to assess natural patient-therapist interactions in order to map such human-human activities to robot-human interactions. Critical to accomplishing this mapping will be determining the feasibility of a humanoid robot interacting with a patient in a more intuitive and flexible way, while concomitantly investigating the issue of safe contact and release.
Detailed description
Stroke survivors with varying levels of motor deficit impairment in their upper extremity (UE) will be assessed using standardized clinical scales for cognition and motor impairment. Following assessment, the patient and therapist will complete a therapy session consisting of activities of daily living (ADL).
During the therapy session, visual 3D motion tracking will be used via Kinect, audio will be recorded, and basic measurements (i.e. the distance between a participants wrist and elbow) will be taken. After the patient-therapist interaction has been mapped, members of the research team will build computer based models of the therapist and patient using the insights gained from the human-human interaction. The models developed in this proposed study will be used as a template for programming safe and intuitive humanoid-patient interactions for future study. The model of the therapist will be implemented on the Robot (w/o a patient involved) and in a simulation environment where it will be tested with a computer-based model of the patient.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke survivors and healthy subjects | Experimental | Device: Rehab InterCap system and 3D KinectStroke survivors greater than 18 years of age with hemiplegia and varying levels of impairment as well as healthy subjects greater than 18 years old with no motor disabilities will be asked to interact with a therapist. The Patient-Therapist interactions will be recorded using the Rehab Intercap System and 3D Kinect Device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke survivors 18 years of age with hemiplegia and varying levels of impairment
- Healthy subjects greater than 18 years of age with no motor disabilities
Key exclusion criteria (1 listed)
- Under 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 |
|---|---|---|
| Rehab InterCap system and 3D KinectThe therapist will conduct a therapy session which will consist of various activities of daily living. During the session, the motion of the therapist and patients will be collected with a custom motion capture system (Rehab InterCap) and 3D visual mapping may take place using the Kinect device, audio will be recorded, and basic measurements of length (i.e. the distance from a participant's shoulder to elbow) will be taken. Patients and therapists will wear the sensors to capture their arm movements. 3D video motion capture may be completed with some subjects. This will involve subjects wearing reflective markers on their upper arms in addition to the intercap sensors. | Device | Stroke survivors and healthy subjects |
Primary outcome
Patient-Therapist Interaction Mapping
Time frame: 1 session, about 2 hours in length
Using the data collected during the subject's visit to the Rehabilitation Robotics Lab, computer-based models of the therapist and the patient will be devised. These models may be used in future studies with a robot Video collection of patient-therapists in real settings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- 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?
A study testing Rehab InterCap system and 3D Kinect in people with Stroke and Hemiplegia, 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 2 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: paused, as of the sponsor's last update on 1 Feb 2024. 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?
Results are not available in the source record.
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?
Patient-Therapist Interaction Mapping (time frame: 1 session, about 2 hours in length). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2024.