- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06756958
Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy
Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy Among Patients with Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 01022
- National Rehabilitation Center
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Seoul, Korea, Republic of, 142884
- Jung Hwan Kim
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
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
|
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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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRC-2017-04-037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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