StrokeNCT06756958
Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy
An observational study of Stroke, run by National Rehabilitation Center, Seoul, Korea at 2 sites in South Korea.
Trial summary
Reliability and validity of Pittsburgh Rehabilitation Participation Scale during robot therapy among patients with stroke Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 46 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Sep 2017to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with stroke or traumatic brain injury
- inpatient in rehabilitation center
Who cannot join
- brain tumor
- spinal cord injury
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
National Rehabilitation Center
Seoul, 01022
Jung Hwan Kim
Seoul, 142884
About this study
Official title: 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
- Conditions
- Stroke
- Being tested
- No intervention (observational study)
- Keywords
- participation, robot, scale, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study: The study participants were inpatient and were given robot-assisted gait training routinely.)
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Rehabilitation Participation Scale
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.
Measured: through study completion, an average of 3 year
Secondary outcomes (14)
modified Barthel Index
Modified Barthel Index measures basic activities of daily life. Lowest score is zero and means no function. Highiest score is 100, best function.
Measured: baseline and 4 weeks from baseline
10m walk
Measured: baseline and 4 weeks from baseline
Borg scale
Borg scale measures perceived exertion during the test. It ranges 13 to 20. 13 means easy. 20 means hardest.
Measured: baseline and 4 weeks from baseline
6 min walk
Measured: baseline and 4 weeks from baseline
motricity index
Measured: baseline and 4 weeks from baseline
Berg balance scale
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.
Measured: baseline and 4 weeks from baseline
Trunk impairment scale
Scores range from a minimum of 0 to a maximum of 23. Zero means no balance. 23 means maximal balance and trunk function.
Measured: baseline and 4 weeks from baseline
Function in sitting test
Measured: baseline and 4 weeks from baseline
Modified Rankin Scale for Neurologic Disability
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.
Measured: baseline and 4 weeks from baseline
Functional Ambulatory Category
Measured: baseline and 4 weeks from baseline
Timed Timed Up and Go test
Measured: baseline and 4 weeks from baseline
Manual Muscle Testing
Measured: baseline and 4 weeks from baseline
modified Ashworth scale
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.
Measured: baseline and 4 weeks from baseline
National Institutes of Health Stroke Scale
0 to 24 points. Zero (0) means no deficits as the criteria. 24 means means maximal deficits as the criteria.
Measured: baseline and 4 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Sep 2017
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Why it stopped: The researcher, who recruit, resigned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kim, Jung Hwan, National Rehabilitation Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756958
- Sponsor's protocol ID
- NRC-2017-04-037
- Status last verified
- Dec 2024
- First submitted
- 10 Nov 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy Among Patients with Stroke
- ClinicalTrials.gov ID
- NCT06756958
- Acronym / sponsor ID
- NRC-2017-04-037
- Conditions
- Stroke
- Keywords
- participation, robot, scale, rehabilitation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The researcher, who recruit, resigned.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reliability and validity of Pittsburgh Rehabilitation Participation Scale during robot therapy among patients with stroke
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients with stroke or traumatic brain injury
- inpatient in rehabilitation center
Key exclusion criteria (2 listed)
- brain tumor
- spinal cord injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)No intervention (observational study: The study participants were inpatient and were given robot-assisted gait training routinely.) | Other | – |
Primary outcome
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.
14 secondary outcomes
modified Barthel Index
Time frame: baseline and 4 weeks from baseline
10m walk
Time frame: baseline and 4 weeks from baseline
Borg scale
Time frame: baseline and 4 weeks from baseline
6 min walk
Time frame: baseline and 4 weeks from baseline
motricity index
Time frame: baseline and 4 weeks from baseline
Berg balance scale
Time frame: baseline and 4 weeks from baseline
Trunk impairment scale
Time frame: baseline and 4 weeks from baseline
Function in sitting test
Time frame: baseline and 4 weeks from baseline
Modified Rankin Scale for Neurologic Disability
Time frame: baseline and 4 weeks from baseline
Functional Ambulatory Category
Time frame: baseline and 4 weeks from baseline
Timed Timed Up and Go test
Time frame: baseline and 4 weeks from baseline
Manual Muscle Testing
Time frame: baseline and 4 weeks from baseline
modified Ashworth scale
Time frame: baseline and 4 weeks from baseline
National Institutes of Health Stroke Scale
Time frame: baseline and 4 weeks from baseline
Results and safety
The study was stopped early (reason given: The researcher, who recruit, resigned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Description site of the present studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by National Rehabilitation Center, Seoul, Korea at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The researcher, who recruit, resigned.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Rehabilitation Participation Scale (time frame: through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.