NCT02806843

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

10.6 years

First QC Date

June 16, 2016

Last Update Submit

January 30, 2024

Conditions

Keywords

strokehemiplegiahealthyroboticsrehabilitationtherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 session, about 2 hours in length

Study Arms (1)

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.

Device: Rehab InterCap system and 3D Kinect

Interventions

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.

Stroke survivors and healthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michelle J Johnson, PhD

    Penn Medicine Rittenhouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 21, 2016

Study Start

May 1, 2014

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations