StrokeNCT07359001
Video-based Sit-to-stand Evaluation for Stroke Patients
An observational study of Stroke and Stroke Rehabilitation, run by Sahmyook University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Stroke Rehabilitation
- What is being tested?
- Observation
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2023to 31 May 2023
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of stroke patients currently admitted to H Hospital located in Namyangju-si, Gyeonggi-do, South Korea.
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria included individuals with visual, auditory, or vestibular impairments, cognitive dysfunction, more than two episodes of stroke, or other neurological impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Video-based Sit-to-stand Evaluation Tool for Stroke Patients
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.
Read the detailed description
- Rationale and Context
- Stroke remains a leading global cause of long-term functional disability. While early functional recovery is rapid, many patients require sustained long-term rehabilitation. Access to adequate rehabilitation is often compromised by geographical and institutional barriers, highlighting a critical unmet need in clinical practice. Tele-rehabilitation, utilizing Information and Communications Technology (ICT) via devices such as smartphones and tablets, is presented as a vital alternative to enhance accessibility and provide continuous, systematic care without the need for physical travel. The success of tele-rehabilitation fundamentally depends on the availability of assessment tools that can objectively and reliably measure functional changes from a distance.
- Scientific Focus: Sit-to-Stand (STS) Movement
- The Sit-to-Stand (STS) task is a foundational activity of daily living, demanding complex coordination of lower extremity strength, balance, posture control, and weight shifting. Post-stroke, patients exhibit significant limitations in STS due to asymmetric weight-bearing, decreased strength, and impaired postural control, which increases the risk of falls. Therefore, the assessment of STS must extend beyond simple quantitative measures (e.g., time or repetition counts, such as FTSTS or TUG) to capture the qualitative characteristics (e.g., symmetry, compensatory strategies) essential for guiding therapeutic intervention. This study addresses the current limitation of existing qualitative tools that require direct, in-person observation by developing a tool suitable for non-face-to-face video analysis.
- Assessment Tool Development Methodology
- The study utilized a multi-stage process for tool construction, ensuring both clinical relevance and theoretical soundness:
- Initial Item Generation: The preliminary tool items were compiled based on a comprehensive literature review and clinical books related to stroke patient posture and balance assessment, with a specific focus on alignment and movement analysis during STS. The tool ultimately adopted concepts from Raine et al.'s Bobath concept theory.
- Item Structuring: The STS movement was segmented into five functional phases (including a preparation phase added later). The items, totaling 29 items, are structured for observation from both the frontal and sagittal (affected side) planes, and scored on a 5-point Likert scale for most items.
- Validation Procedures (Content/Face Validity): The preliminary tool underwent rigorous validation. Face validity was assessed by a panel of expert physical therapists. Content validity was verified by 10 neurological rehabilitation therapists with over 10 years of experience, following established procedures. This iterative process led to the deletion, modification, and addition of items, ensuring the tool's clinical relevance and comprehensiveness.
- Video Recording Protocols: To minimize observational bias and establish remote feasibility, the assessment guidelines mandate that the STS movement be recorded from the patient's front (coronal view) and affected side (sagittal view). The videos are then edited to allow simultaneous viewing of both perspectives, ensuring full visibility from head to toe.
- Study Procedures for Reliability
- The final version of the tool was tested using video recordings of STS movements from 10 chronic stroke patients. The assessments were conducted by 10 neurological physical therapists with over three years of experience.
- Inter-Rater Reliability: Measured the consistency of scoring among the 28 different evaluators using the same video recordings. The ICC(2,1) model was applied for this analysis.
- Intra-Rater Reliability: Measured the consistency of individual evaluators by having the same 10 evaluators assess the identical video recordings two times, separated by an interval of approximately 6 months. The ICC(3,1) model was applied for this analysis.
- Statistical Analysis The consistency of measurements (Reliability) was quantified using the Intraclass Correlation Coefficient (ICC). The interpretation of the ICC values followed standard guidelines (e.g., ICC ≥0.90 is considered 'excellent', 0.75-0.90 is 'good', 0.50-0.75 is 'moderate').
- Conditions
- Stroke, Stroke Rehabilitation
- Being tested
- Observation
- Keywords
- Stroke, Telerehabilitation, Scale, Reproducibility of Results, Correlation of Data, Biomechanical Phenomena, Range of Motion, Articular, Video Recording, Posture
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Stroke patients are video recorded during three sit-to-stand trials with 5 minutes rest between the trials.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | No interventions are provided. They will be video recorded during their sit-to-stand trials of three Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
To establish criterion validity, the total score obtained from the newly developed video-based STS assessment tool is correlated with the score from the Trunk Impairment Scale (TIS). The TIS is a validated tool measuring static and dynamic sitting balance and trunk coordination. TIS scores range from 0 to 23, with higher scores indicating better trunk performance. A Pearson or Spearman correlation coefficient will be calculated to determine the strength of the relationship.
Measured: 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
This measure establishes construct validity by analyzing the relationship between the qualitative assessment (video tool score) and the quantitative performance (speed). A correlation coefficient will be calculated between the total score obtained from the video-based assessment tool (range: 29-145, higher scores indicate better movement quality) and the total time (in seconds) required for the patient to complete the Sit-to-Stand task. This tests the hypothesis that better movement quality correlates with more efficient (faster) performance.
Measured: 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
To verify construct validity, the scores from the video-based tool are compared against quantitative motion analysis data obtained using Kinovea software. The specific kinematic parameters analyzed include the range of motion (degrees) and angular velocity (degrees/second) of the hip, knee, and ankle joints during the Sit-to-Stand motion. Correlation coefficients will be calculated to determine how well the video-based tool's qualitative scores reflect the objective kinematic changes measured by the software.
Measured: At baseline, during a single assessment session following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Apr 2023
- Primary completion31 May 2023
- Study completion31 May 2023
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanbin Kim, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359001
- Sponsor's protocol ID
- SYU 2022-10-012-007
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Video-based Sit-to-stand Evaluation Tool for Stroke Patients
- ClinicalTrials.gov ID
- NCT07359001
- Acronym / sponsor ID
- SYU 2022-10-012-007
- Conditions
- Stroke, Stroke Rehabilitation
- Keywords
- Stroke, Telerehabilitation, Scale, Reproducibility of Results, Correlation of Data, Biomechanical Phenomena, Range of Motion, Articular, Video Recording
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 22 Jan 2026 (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.
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.
Detailed description
- Rationale and Context
- Stroke remains a leading global cause of long-term functional disability. While early functional recovery is rapid, many patients require sustained long-term rehabilitation. Access to adequate rehabilitation is often compromised by geographical and institutional barriers, highlighting a critical unmet need in clinical practice. Tele-rehabilitation, utilizing Information and Communications Technology (ICT) via devices such as smartphones and tablets, is presented as a vital alternative to enhance accessibility and provide continuous, systematic care without the need for physical travel. The success of tele-rehabilitation fundamentally depends on the availability of assessment tools that can objectively and reliably measure functional changes from a distance.
- Scientific Focus: Sit-to-Stand (STS) Movement
- The Sit-to-Stand (STS) task is a foundational activity of daily living, demanding complex coordination of lower extremity strength, balance, posture control, and weight shifting. Post-stroke, patients exhibit significant limitations in STS due to asymmetric weight-bearing, decreased strength, and impaired postural control, which increases the risk of falls. Therefore, the assessment of STS must extend beyond simple quantitative measures (e.g., time or repetition counts, such as FTSTS or TUG) to capture the qualitative characteristics (e.g., symmetry, compensatory strategies) essential for guiding therapeutic intervention. This study addresses the current limitation of existing qualitative tools that require direct, in-person observation by developing a tool suitable for non-face-to-face video analysis.
- Assessment Tool Development Methodology
- The study utilized a multi-stage process for tool construction, ensuring both clinical relevance and theoretical soundness:
- Initial Item Generation: The preliminary tool items were compiled based on a comprehensive literature review and clinical books related to stroke patient posture and balance assessment, with a specific focus on alignment and movement analysis during STS. The tool ultimately adopted concepts from Raine et al.'s Bobath concept theory.
- Item Structuring: The STS movement was segmented into five functional phases (including a preparation phase added later). The items, totaling 29 items, are structured for observation from both the frontal and sagittal (affected side) planes, and scored on a 5-point Likert scale for most items.
- Validation Procedures (Content/Face Validity): The preliminary tool underwent rigorous validation. Face validity was assessed by a panel of expert physical therapists. Content validity was verified by 10 neurological rehabilitation therapists with over 10 years of experience, following established procedures. This iterative process led to the deletion, modification, and addition of items, ensuring the tool's clinical relevance and comprehensiveness.
- Video Recording Protocols: To minimize observational bias and establish remote feasibility, the assessment guidelines mandate that the STS movement be recorded from the patient's front (coronal view) and affected side (sagittal view). The videos are then edited to allow simultaneous viewing of both perspectives, ensuring full visibility from head to toe.
- Study Procedures for Reliability
- The final version of the tool was tested using video recordings of STS movements from 10 chronic stroke patients. The assessments were conducted by 10 neurological physical therapists with over three years of experience.
- Inter-Rater Reliability: Measured the consistency of scoring among the 28 different evaluators using the same video recordings. The ICC(2,1) model was applied for this analysis.
- Intra-Rater Reliability: Measured the consistency of individual evaluators by having the same 10 evaluators assess the identical video recordings two times, separated by an interval of approximately 6 months. The ICC(3,1) model was applied for this analysis.
- Statistical Analysis The consistency of measurements (Reliability) was quantified using the Intraclass Correlation Coefficient (ICC). The interpretation of the ICC values followed standard guidelines (e.g., ICC ≥0.90 is considered 'excellent', 0.75-0.90 is 'good', 0.50-0.75 is 'moderate').
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: ObservationNo interventions are provided. They will be video recorded during their sit-to-stand trials of three |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of stroke patients currently admitted to H Hospital located in Namyangju-si, Gyeonggi-do, South Korea.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria included individuals with visual, auditory, or vestibular impairments, cognitive dysfunction, more than two episodes of stroke, or other neurological impairments.
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 |
|---|---|---|
| ObservationStroke patients are video recorded during three sit-to-stand trials with 5 minutes rest between the trials. | Other | Stroke patients |
Primary outcome
Inter-rater Reliability of the Video-Based Sit-to-Stand (STS) Assessment Tool as Assessed by the Intraclass Correlation Coefficient (ICC 2,1)
Time frame: At baseline, during a single assessment session following enrollment
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.
Intra-rater Reliability of the Video-Based Sit-to-Stand (STS) Assessment Tool as Assessed by the Intraclass Correlation Coefficient (ICC 3,1)
Time frame: At baseline, during a single assessment session following enrollment
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.
3 secondary outcomes
Criterion Validity: Correlation Between the Video-Based STS Assessment Tool Score and the Trunk Impairment Scale (TIS) Score
Time frame: 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
Time frame: 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
Time frame: At baseline, during a single assessment session following enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke Rehabilitation, run by Sahmyook University at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inter-rater Reliability of the Video-Based Sit-to-Stand (STS) Assessment Tool as Assessed by the Intraclass Correlation Coefficient (ICC 2,1) (time frame: At baseline, during a single assessment session following enrollment). The study lists 2 primary outcomes in all. 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 22 Jan 2026.