NCT05417802

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress88%
Dec 2021Dec 2026

Study Start

First participant enrolled

December 8, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2026

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

June 5, 2022

Last Update Submit

March 20, 2025

Conditions

Outcome Measures

Primary Outcomes (13)

  • 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

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients

You may qualify if:

  • Adults with stroke
  • Adults with no cognitive difficulties

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jiyeon Kang

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2022

First Posted

June 14, 2022

Study Start

December 8, 2021

Primary Completion (Estimated)

December 7, 2026

Study Completion (Estimated)

December 7, 2026

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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

Time Frame
After the study is completed
Access Criteria
The personnel who is requesting the data needs to explain how the data will be used in their research.

Locations