HemiparesisNCT03096262
Transforming Robot-mediated Telerehabilitation: Citizen Science for Rehabilitation
A study testing Citizen Science intervention using kinect in people with Hemiparesis and Stroke, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiparesis, Stroke
- What is being tested?
- Citizen Science intervention using kinect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 21 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- no history of learning disabilities (iii) technical savvy and interest to use an internet platform
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Hemiparesis, Stroke
- Being tested
- Citizen Science intervention using kinect
- Keywords
- cognitive skills, technical, internet platform, Stroke, Hemiparesis
- Medical subject headings
- Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citizen Science intervention using kinectDevice
Users are asked to tag objects on a screen
| Study group | Role | What they receive |
|---|---|---|
| Stroke Patients | Experimental | Not described Receives: Device: Citizen Science intervention using kinect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start27 Apr 2021
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Foundation, Foundation for Physical Medicine and Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Preeti Raghavan, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096262
- Sponsor's protocol ID
- IRB00225650
- Status last verified
- Jul 2025
- First submitted
- 24 Mar 2017
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Kinect-Based Citizen Science Telerehabilitation Platform
- ClinicalTrials.gov ID
- NCT03096262
- Acronym / sponsor ID
- IRB00225650
- Conditions
- Hemiparesis, Stroke
- Keywords
- cognitive skills, technical, internet platform, Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Science Foundation, Foundation for Physical Medicine and Rehabilitation
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Patients | Experimental | Device: Citizen Science intervention using kinect |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citizen Science intervention using kinectUsers are asked to tag objects on a screen | Device | Stroke Patients |
Primary outcome
Feasibility of the kinect motion capture platform to capture movement assessed by range of motion
Time frame: 1 day
Range-of-motion measurements of the affected and unaffected arm using the kinect motion capture platform.
Feasibility of the kinect motion capture platform to capture workload assessed by NASA Task Load Index
Time frame: 1 day
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.
Feasibility of the kinect motion capture platform usability assessed by the System usability scale
Time frame: 1 day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Hemiparesis
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Telerehabilitation for Post-Stroke Hand Function
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Kinematic Analysis of Manual Dexterity
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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preeti Raghavan, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citizen Science intervention using kinect in people with Hemiparesis and Stroke, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the kinect motion capture platform to capture movement assessed by range of motion (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.