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Transforming Robot-mediated Telerehabilitation: Citizen Science for Rehabilitation

Primary Purpose

Hemiparesis, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Output-Focus Condition
Input-Focus Condition
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemiparesis focused on measuring cognitive skills, technical, internet platform, Stroke, Hemiparesis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Matthew BirdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stroke Patients

Healthy Controls

Arm Description

Outcomes

Primary Outcome Measures

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.
Video-based motion analysis
Passive and active range-of-motion measurements of the affected and unaffected arm using video-based motion analysis
assessment of tone using Ashworth scale
this scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2017
Last Updated
January 23, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03096262
Brief Title
Transforming Robot-mediated Telerehabilitation: Citizen Science for Rehabilitation
Official Title
Feasibility of a Kinect-Based Citizen Science Telerehabilitation Platform
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Stroke
Keywords
cognitive skills, technical, internet platform, Stroke, Hemiparesis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke Patients
Arm Type
Experimental
Arm Title
Healthy Controls
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Output-Focus Condition
Intervention Description
Users are asked to tag more, and force feedback is exerted the more points the user has
Intervention Type
Behavioral
Intervention Name(s)
Input-Focus Condition
Intervention Description
Users are asked to tag more and force feedback is exerted based on the number of images the user has analyzed.
Primary Outcome Measure Information:
Title
Fugl-Meyer scale
Description
Stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Time Frame
1 Month
Title
Video-based motion analysis
Description
Passive and active range-of-motion measurements of the affected and unaffected arm using video-based motion analysis
Time Frame
1 Month
Title
assessment of tone using Ashworth scale
Description
this scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Bird, MA
Phone
410-955-1347
Email
mbird6@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Bird, MA
Phone
410-955-1381
Email
mbird6@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preeti Raghavan, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matthew Bird
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Bird, MD
Phone
410-955-1347
Email
mbird6@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Matthew Bird, MA
Phone
410-955-1381
Email
mbird6@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Preeti Raghavan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Transforming Robot-mediated Telerehabilitation: Citizen Science for Rehabilitation

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