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

January 30, 2024 updated by: University of Pennsylvania
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke survivors and healthy subjects
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.
Device: Rehab InterCap system and 3D Kinect
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 session, about 2 hours in length

Collaborators and Investigators

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

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Michelle J Johnson, PhD, Penn Medicine Rittenhouse

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

May 1, 2014

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimated)

June 21, 2016

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 820068

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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