Transforming Robot-mediated Telerehabilitation: Citizen Science for Rehabilitation

Stroke Clinical Trial

Official title:

Feasibility of a Kinect-Based Citizen Science Telerehabilitation Platform

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096262
• Other study ID #: IRB00225650
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Matthew Bird, MA
• Phone: 410-955-1347
• Email: mbird6[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Behavioral:
• Output-Focus Condition
Users are asked to tag more, and force feedback is exerted the more points the user has
• Input-Focus Condition
Users are asked to tag more and force feedback is exerted based on the number of images the user has analyzed.

Locations

Country	Name	City	State
United States	Matthew Bird	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Video-based motion analysis	Passive and active range-of-motion measurements of the affected and unaffected arm using video-based motion analysis	1 Month
Primary	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