NCT06756958

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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 Start

First participant enrolled

September 1, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

4.2 years

First QC Date

November 10, 2024

Last Update Submit

December 30, 2024

Conditions

Keywords

participationrobotscalerehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 3 year

Secondary Outcomes (14)

  • modified Barthel Index

    baseline and 4 weeks from baseline

  • 10m walk

    baseline and 4 weeks from baseline

  • Borg scale

    baseline and 4 weeks from baseline

  • 6 min walk

    baseline and 4 weeks from baseline

  • motricity index

    baseline and 4 weeks from baseline

  • +9 more secondary outcomes

Interventions

No intervention (observational study: The study participants were inpatient and were given robot-assisted gait training routinely.)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • brain tumor
  • spinal cord injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Rehabilitation Center

Seoul, 01022, South Korea

Location

Jung Hwan Kim

Seoul, 142884, South Korea

Location

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager

Study Record Dates

First Submitted

November 10, 2024

First Posted

January 3, 2025

Study Start

September 1, 2017

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations