- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359001
Video-based Sit-to-stand Evaluation for Stroke Patients
Development of Video-based Sit-to-stand Evaluation Tool for Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Seoul
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Seoul, Seoul, South Korea, 01795
- Sahmyook University, Science Hall 3
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Exclusion criteria included individuals with visual, auditory, or vestibular impairments, cognitive dysfunction, more than two episodes of stroke, or other neurological impairments.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Stroke patients
No interventions are provided.
They will be video recorded during their sit-to-stand trials of three
|
Stroke patients are video recorded during three sit-to-stand trials with 5 minutes rest between the trials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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.
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At baseline, during a single assessment session following enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
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At baseline, during a single assessment session following enrollment
|
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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
|
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.
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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
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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.
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At baseline, during a single assessment session following enrollment
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Collaborators and Investigators
Sponsor
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
- SYU 2022-10-012-007
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
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