NCT07359001

Brief Summary

The purpose of this study is to develop and validate a novel video-based postural evaluation tool designed to objectively measure the quality and dynamics of the Sit-to-Stand (STS) motion in stroke patients, specifically allowing physical therapists to monitor patient progress remotely via tele-evaluation. Since stroke survivors often face difficulties attending regular in-clinic assessments, this tool addresses a critical unmet need. The core question this study aims to answer is whether this new video-based measurement can accurately and consistently assess standing ability when compared against established standards. To confirm the tool's trustworthiness, we will first test its reliability by assessing if different experts achieve the same results (Inter-rater reliability) and if the same expert achieves the same results across multiple trials (Intra-rater reliability). We will then confirm the tool's accuracy (validity) by examining if its derived scores correlate strongly with established clinical measures (e.g., Trunk Impairment Scale, TIS) and patient-reported outcome measures. Finally, we will verify its scientific precision by comparing the tool's detailed kinematic measurements (including total STS time and joint angles) against the gold-standard data derived from the Kinovea motion analysis software.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 27, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

StrokeTelerehabilitationScaleReproducibility of ResultsCorrelation of DataBiomechanical PhenomenaRange of Motion, ArticularVideo RecordingPosture

Outcome Measures

Primary Outcomes (2)

  • Inter-rater Reliability of the Video-Based Sit-to-Stand (STS) Assessment Tool as Assessed by the Intraclass Correlation Coefficient (ICC 2,1)

    The inter-rater reliability assesses the degree of agreement among 28 different physical therapists evaluating the same patient videos. The video-based STS assessment tool consists of 29 items across 5 phases (Phase 0: Preparation, Phase 1: Flexion Momentum, Phase 2: Momentum Transfer, Phase 3: Extension, Phase 4: Stabilization). Each item is scored on a 5-point Likert scale ranging from 1 (poor performance/unable) to 5 (perfect performance). The total score is the sum of all items. Reliability is reported using the Intraclass Correlation Coefficient (ICC) model 2,1. An ICC value ≥ 0.90 indicates excellent reliability, 0.75-0.90 good, 0.50-0.75 moderate, and \< 0.50 poor reliability.

    At baseline, during a single assessment session following enrollment

  • Intra-rater Reliability of the Video-Based Sit-to-Stand (STS) Assessment Tool as Assessed by the Intraclass Correlation Coefficient (ICC 3,1)

    The intra-rater reliability assesses the consistency of the same rater's scoring over time. Ten physical therapists evaluated the same patient video recordings at baseline and again after a specific interval. The assessment tool comprises 29 items scored on a 1 to 5 scale, where higher scores indicate better performance. The consistency between the two time points is calculated using the Intraclass Correlation Coefficient (ICC) model 3,1.

    At baseline, during a single assessment session following enrollment

Secondary Outcomes (3)

  • Criterion Validity: Correlation Between the Video-Based STS Assessment Tool Score and the Trunk Impairment Scale (TIS) Score

    At baseline, during a single assessment session following enrollment

  • Criterion Validity: Correlation Between the Video-Based STS Assessment Tool Score and Total Sit-to-Stand Duration

    At baseline, during a single assessment session following enrollment

  • Construct Validity: Correlation Between Video-Based STS Assessment Tool Scores and Kinematic Parameters (Joint Angles and Angular Velocities) Measured by Kinovea Software

    At baseline, during a single assessment session following enrollment

Study Arms (1)

Stroke patients

No interventions are provided. They will be video recorded during their sit-to-stand trials of three

Other: Observation

Interventions

Stroke patients are video recorded during three sit-to-stand trials with 5 minutes rest between the trials.

Stroke patients

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of stroke patients currently admitted to H Hospital located in Namyangju-si, Gyeonggi-do, South Korea.

You may qualify if:

  • Patients diagnosed with stroke resulting in motor impairment.
  • Patients in the chronic phase, defined as being more than one year post-diagnosis.
  • Patients capable of performing the Sit-to-Stand (STS) movement independently without the use of walking aids or physical assistance.
  • Patients who fully understand the study purpose and procedures and have voluntarily provided written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahmyook University, Science Hall 3

Seoul, Seoul, 01795, South Korea

Location

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
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

November 27, 2025

First Posted

January 22, 2026

Study Start

April 1, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

January 22, 2026

Record last verified: 2025-11

Locations