Transforming Robot-mediated Telerehabilitation: Citizen Science for Rehabilitation

Feasibility of a Kinect-Based Citizen Science Telerehabilitation Platform

The purpose of this study is to advance upper limb robot-mediated tele-rehabilitation for patients recovering from stroke by empowering them through active science participation. By varying the tasks' features and affordances of a platform that combines a low-cost haptic device on one hand, and an online citizen science platform on the other, investigators will evaluate different strategies for social telerehabilitation. the two fundamental modes of social interaction - competition and cooperation - in addition to a control condition. Specifically, citizen science activities will be performed by competing, cooperating, or isolated users, and their rehabilitation effectiveness examined. Such effectiveness will be measured by (i) participants' rehabilitation performance (inferred from sensorimotor data acquired through the platform and directly quantified by a supervising therapist); (ii) participants' motivations to contribute (measured through surveys administered online); and (iii) participants' emotional well-being and sense of self-esteem (measured through online surveys).

Study Overview

• Status: Recruiting
• Conditions: Stroke; Hemiparesis
• Intervention / Treatment: Behavioral: Output-Focus Condition; Behavioral: Input-Focus Condition

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Bird, MA; Phone Number: 410-955-1381; Email: mbird6@jhmi.edu
• Study Contact Backup: Name: Matthew Bird, MA; Phone Number: 410-955-1347; Email: mbird6@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Recruiting
      • Matthew Bird
      • Contact: Matthew Bird, MA; Phone Number: 410-955-1381; Email: mbird6@jhmi.edu
      • Contact: Matthew Bird, MD; Phone Number: 410-955-1347; Email: mbird6@jhmi.edu
      • Principal Investigator: Preeti Raghavan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For treatment group:

• post-stroke hemiparesis >3 months
• ability to stand or sit independently
• sufficient cognitive skills to perform the exercises as demonstrated
• full passive range of motion in the affected arm but limited active movement as determined by a upper extremity Fugl-Meyer score of <50/66
• technical savvy and interest to use an internet platform

For control group:

(ii) no history of learning disabilities (iii) technical savvy and interest to use an internet platform

Exclusion Criteria:

For treatment group:

• visual deficit such as deficit in visual acuity, eye movements, visual field cut, or neglect
• medical comorbidity such as other neurological conditions (e.g. Parkinson's disease, brain tumor, epilepsy), or previous injury to the upper limb
• pain in the upper limbs that prevents full passive range of motion to perform the exercises.

For control group:

• visual deficit such as deficit in visual acuity, eye movements, visual field cut, or neglect
• any previous injury or medical condition that prevents full passive range of motion to perform the exercises.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Controls	Behavioral: Output-Focus Condition; Users are asked to tag more, and force feedback is exerted the more points the user has; Behavioral: Input-Focus Condition; Users are asked to tag more and force feedback is exerted based on the number of images the user has analyzed.
Experimental: Stroke Patients	Behavioral: Output-Focus Condition; Users are asked to tag more, and force feedback is exerted the more points the user has; Behavioral: Input-Focus Condition; Users are asked to tag more and force feedback is exerted based on the number of images the user has analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer scale	Stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.	1 Month
Video-based motion analysis	Passive and active range-of-motion measurements of the affected and unaffected arm using video-based motion analysis	1 Month
assessment of tone using Ashworth scale	this scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.	1 Month

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Preeti Raghavan, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Hemiparesis; cognitive skills; internet platform; technical
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: IRB00225650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No