Transforming Robot-mediated Telerehabilitation: Citizen Science for Rehabilitation

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03096262

Collaborator

(none)

Enrollment

Location

Arms

20.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hemiparesis Stroke	Behavioral: Output-Focus Condition Behavioral: Input-Focus Condition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Feasibility of a Kinect-Based Citizen Science Telerehabilitation Platform

Actual Study Start Date :

Apr 27, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Fugl-Meyer scale [1 Month]
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 [1 Month]
Passive and active range-of-motion measurements of the affected and unaffected arm using video-based motion analysis
assessment of tone using Ashworth scale [1 Month]
this scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.