NCT03096262

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
4.1 years until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

4.1 years

First QC Date

March 24, 2017

Last Update Submit

July 7, 2025

Conditions

HemiparesisStroke

Keywords

cognitive skillstechnicalinternet platformStrokeHemiparesis

Outcome Measures

Primary Outcomes (3)

  • Feasibility of the kinect motion capture platform to capture movement assessed by range of motion

    Range-of-motion measurements of the affected and unaffected arm using the kinect motion capture platform.

    1 day

  • Feasibility of the kinect motion capture platform to capture workload assessed by NASA Task Load Index

    Assesses work load on five 7-point scales. A series of measures that capture workload. Each scale employs a visual analog scale that measures each of the domains. The domains are Mental Domain, Physical Demand, Temporal Demand, Performance, Effort and Frustration Level. Each scale domain and the Composite has a range from 0 to 100 with 100 being the highest indicator of workload.

    1 day

  • Feasibility of the kinect motion capture platform usability assessed by the System usability scale

    Using a 10 item scale to assess the usability of the technology platform with stroke patients. The measure is scored on a 0-100 scale, a higher score means a better outcome.

    1 day

Study Arms (1)

Stroke Patients

EXPERIMENTAL
Device: Citizen Science intervention using kinect

Interventions

Citizen Science intervention using kinectDEVICE

Users are asked to tag objects on a screen

Stroke Patients

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matthew Bird

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

ParesisStroke

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Preeti Raghavan, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 24, 2017

First Posted

March 30, 2017

Study Start

April 27, 2021

Primary Completion

May 21, 2025

Study Completion

May 21, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)