Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy

December 30, 2024 updated by: Kim, Jung Hwan, National Rehabilitation Center, Seoul, Korea

Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy Among Patients with Stroke

Reliability and validity of Pittsburgh Rehabilitation Participation Scale during robot therapy among patients with stroke

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
46

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 01022
        • National Rehabilitation Center
      • Seoul, Korea, Republic of, 142884
        • Jung Hwan Kim

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Those who participated the tethered-robot assisted gait training, had the history of brain lesion and adimitted in the rehabilitation center.

Those who gave the informed consent about this study.

Description

Inclusion Criteria:

  • patients with stroke or traumatic brain injury
  • inpatient in rehabilitation center

Exclusion Criteria:

  • brain tumor
  • spinal cord injury

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

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
Pittsburgh Rehabilitation Participation Scale
Time Frame: through study completion, an average of 3 year

Pittsburgh Rehabilitation Participation Scale could be 1 (none), 2, 3, 4, 5, or 6 (excellent).

Excellent (6): If the patient participated in all exercises or activities with maximal effort, finished all exercises or activities, and actively took interest in exercises or activities and/or future therapy sessions.

None (1): patient refused entire session, or did not participate in any exercises or activities in session.

In this study, a participant typically gets 12 sessions of robot assisted gait training. Just after the each session, Pittsburgh Rehabilitation Participation Scale is assigned as 1 to 6.

For example, in a virtual case, the participant gets the score of 1, 1, 2, 2, 3, 3, 4, 4, 5, 5, 6, and 6 (median =3.5). the participant gets 12 numbers of outcome score and median of Pittsburgh Rehabilitation Participation Scale.
through study completion, an average of 3 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
modified Barthel Index
Time Frame: baseline and 4 weeks from baseline
Modified Barthel Index measures basic activities of daily life. Lowest score is zero and means no function. Highiest score is 100, best function.
baseline and 4 weeks from baseline
10m walk
Time Frame: baseline and 4 weeks from baseline
baseline and 4 weeks from baseline
Borg scale
Time Frame: baseline and 4 weeks from baseline
Borg scale measures perceived exertion during the test. It ranges 13 to 20. 13 means easy. 20 means hardest.
baseline and 4 weeks from baseline
6 min walk
Time Frame: baseline and 4 weeks from baseline
baseline and 4 weeks from baseline
motricity index
Time Frame: baseline and 4 weeks from baseline
baseline and 4 weeks from baseline
Berg balance scale
Time Frame: baseline and 4 weeks from baseline

Berg balance scale is the combination of 16 5-point-Likert-scale-like ordinal scale of 0 to 4.

O means no balance. 56 means the maximal balance as the criteria.
baseline and 4 weeks from baseline
Trunk impairment scale
Time Frame: baseline and 4 weeks from baseline
Scores range from a minimum of 0 to a maximum of 23. Zero means no balance. 23 means maximal balance and trunk function.
baseline and 4 weeks from baseline
Function in sitting test
Time Frame: baseline and 4 weeks from baseline
baseline and 4 weeks from baseline
Modified Rankin Scale for Neurologic Disability
Time Frame: baseline and 4 weeks from baseline

Modified Rankin Scale for Neurologic Disability could be 0, 1, 2, 3, 4, 5, or 6.

Zero (0) means no negative symptoms et al as the criteria. 6 means means dead condition (death) as the criteria.
baseline and 4 weeks from baseline
Functional Ambulatory Category
Time Frame: baseline and 4 weeks from baseline
baseline and 4 weeks from baseline
Timed Timed Up and Go test
Time Frame: baseline and 4 weeks from baseline
baseline and 4 weeks from baseline
Manual Muscle Testing
Time Frame: baseline and 4 weeks from baseline
baseline and 4 weeks from baseline
modified Ashworth scale
Time Frame: baseline and 4 weeks from baseline
Modified Ashworth scale could be 0, 1, 1+, 2, 3, or 4. Zero (0) means no spasticity as the criteria. 4 means means maximal spasticity as the criteria.
baseline and 4 weeks from baseline
National Institutes of Health Stroke Scale
Time Frame: baseline and 4 weeks from baseline
0 to 24 points. Zero (0) means no deficits as the criteria. 24 means means maximal deficits as the criteria.
baseline and 4 weeks from baseline

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.
National Rehabilitation Center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
September 1, 2017

Primary Completion (Actual)

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.
October 31, 2021

Study Completion (Actual)

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.
October 31, 2021

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).
November 10, 2024

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.
December 30, 2024

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.
March 25, 2025

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.
December 30, 2024

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.
December 1, 2024

More Information

Terms related to this study

Keywords

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.
  • NRC-2017-04-037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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Conditions

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Locations

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