Surveying Patient's Interest in Robotic Rehabilitation Device

March 20, 2025 updated by: Amit Kandel, MD, MBA, State University of New York at Buffalo
This is a survey study to understand the stroke survivor's interest in robotic training. Investigators will use a questionnaire and show a video of robotic therapy to ask questions on their interest.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The purpose of this research is to investigate the interest of individuals with recent stroke in robotic therapy. Investigators will introduce a novel robotic platform to train ADLs of stroke patients. Investigators will examine the usability of this device as a home trainer for training rotational hand manipulation tasks such as opening a pickle jar, turning a key, missing a pot with a ladle, etc. The device will especially target stroke patients with ischemic stroke to enhance the performance of ADL. Also, investigators will examine the frequency and dosage of the current occupational therapy, followed by the satisfaction of the current therapy. Participant's participation will contribute to the development of a new therapy method using a robotic device for home-based training.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Buffalo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stroke patients

Description

Inclusion Criteria:

  • Adults with stroke
  • Adults with no cognitive difficulties

Exclusion Criteria:

  • Adults with pregnancy,
  • Adults with other neurological disorders than stroke
  • Adults with hemorrhagic stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Stroke with acute stroke

Inclusion criteria

  • Episode of single stroke within the past twelve weeks
  • Individuals' age over 18 years old.

Exclusion criteria

  • Pregnant women , neurological disorders other than stroke (i.e. Parkinson's), non-ischemic stroke
  • Individuals with severe cognitive impairments (demonstrating difficulty to understand, read, and answer the questions in writing)
  • Individuals with difficulties to listen the instruction and video of the robotic device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Current Therapy question - 1
Time Frame: through study completion, an average of 1 year
How many hours are you receiving occupational therapy for each session?
through study completion, an average of 1 year
Current Therapy question - 2
Time Frame: through study completion, an average of 1 year
How frequent are you receiving therapy (ex.: 2/week: two times per week)?
through study completion, an average of 1 year
Current Therapy question - 3
Time Frame: through study completion, an average of 1 year
When did you start your therapy (how many days after stroke)?
through study completion, an average of 1 year
Current Therapy question - 4
Time Frame: through study completion, an average of 1 year
What kind of therapy are you receiving now?
through study completion, an average of 1 year
Current Therapy question - 5
Time Frame: through study completion, an average of 1 year
Do you think that the therapy you are receiving is helpful to restore your arm function and help you participate in activities during daily living (example: drinking, feeding, moving objects)?
through study completion, an average of 1 year
Current Therapy question - 6
Time Frame: through study completion, an average of 1 year
Do you think that you are receiving enough occupational therapy to help you participate in activities during daily living (example: drinking, feeding, moving objects)?
through study completion, an average of 1 year
Interest in Robotic Rehabilitation question - 1
Time Frame: through study completion, an average of 1 year
Do you think that this device can be helpful to improve your arm function from stroke?
through study completion, an average of 1 year
Interest in Robotic Rehabilitation question - 2
Time Frame: through study completion, an average of 1 year
Do you think that you will use the device for home training when it is provided?
through study completion, an average of 1 year
Interest in Robotic Rehabilitation question - 3
Time Frame: through study completion, an average of 1 year
Do you think that the device is helpful to help you participate in activities during daily living (example: drinking, feeding, moving objects)?
through study completion, an average of 1 year
Interest in Robotic Rehabilitation question - 4
Time Frame: through study completion, an average of 1 year
If you have the device at home, how long would you like to exercise with the device?
through study completion, an average of 1 year
Interest in Robotic Rehabilitation question - 5
Time Frame: through study completion, an average of 1 year
If you have the device at home, how frequent would like to use this device?
through study completion, an average of 1 year
Interest in Robotic Rehabilitation question - 6
Time Frame: through study completion, an average of 1 year
Do you think that the training can be more effective by adding virtual reality?
through study completion, an average of 1 year
Interest in Robotic Rehabilitation question - 7
Time Frame: through study completion, an average of 1 year
If the device can apply therapeutic force, which type of force do you prefer for home-training?
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiyeon Kang, University at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified data will be shared upon request to PI.

IPD Sharing Time Frame

After the study is completed

IPD Sharing Access Criteria

The personnel who is requesting the data needs to explain how the data will be used in their research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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