Surveying Patient's Interest in Robotic Rehabilitation Device

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: Active, not recruiting
• Conditions: Stroke, Acute

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: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

Outcome Measure	Measure Description	Time Frame
Current Therapy question - 1	How many hours are you receiving occupational therapy for each session?	through study completion, an average of 1 year
Current Therapy question - 2	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	When did you start your therapy (how many days after stroke)?	through study completion, an average of 1 year
Current Therapy question - 4	What kind of therapy are you receiving now?	through study completion, an average of 1 year
Current Therapy question - 5	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	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	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	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	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	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	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	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	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

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Jiyeon Kang, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Estimated): December 7, 2024
• Study Completion (Estimated): December 7, 2024

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID 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