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Robot-Assisted Stroke Rehabilitation Based on Patient-Therapist Interactions (Baxter)

Primary Purpose

Stroke, Hemiplegia, Healthy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rehab InterCap system and 3D Kinect
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring stroke, hemiplegia, healthy, robotics, rehabilitation, therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Under 18 years of age

Sites / Locations

  • Penn Medicine Rittenhouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stroke survivors and healthy subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2016
Last Updated
July 26, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02806843
Brief Title
Robot-Assisted Stroke Rehabilitation Based on Patient-Therapist Interactions
Acronym
Baxter
Official Title
Robot-Assisted Stroke Rehabilitation Based on Patient-Therapist Interactions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia, Healthy
Keywords
stroke, hemiplegia, healthy, robotics, rehabilitation, therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke survivors and healthy subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Rehab InterCap system and 3D Kinect
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient-Therapist Interaction Mapping
Description
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.
Time Frame
1 session, about 2 hours in length

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Under 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle J Johnson, PhD
Organizational Affiliation
Penn Medicine Rittenhouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine Rittenhouse
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Robot-Assisted Stroke Rehabilitation Based on Patient-Therapist Interactions

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