ClinicalTrials.gg
RecruitingNCT07901985Updated Oct 28, 2026

A Rehabilitation Data Collection Study in Patients With Spinal Cord Injury

An observational study in Spinal Cord Injuries (SCI), sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Seoul National University Hospital · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
Updated Oct 28, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Sex
All
01

Study summary

The goal of this observational study is to build a rehabilitation registry for people with spinal cord injury (SCI) in Korea and to create foundational data for predicting patients' long-term function. The main question it aims to answer is:

- Can a person's long-term level of disability and functional status after SCI be predicted by collecting medical and socioeconomic information together?

Participants receiving inpatient rehabilitation after a spinal cord injury will:

  • Complete a first (baseline) survey and standard assessments of daily functioning, walking ability, quality of life, and disability at the time of admission
  • Complete the same assessments again about 6 months and 12 months after discharge
  • Provide information on their health, use of medical services, employment, income, and social participation during follow-up
Read the detailed description

This is a prospective, single-center observational registry study conducted at the National Traffic Injury Rehabilitation Hospital in Korea. It forms the first stage of a multi-year initiative (2024-2026, funded by the National Rehabilitation Center) intended to design and establish a comprehensive rehabilitation registry for patients with spinal cord injury (SCI) and to generate foundational data for predicting patients' long-term functional status.

Eligible patients are enrolled during inpatient rehabilitation using a systematic selection approach, after the purpose and procedures of the study-including the follow-up surveys-are explained and written informed consent is obtained. Recruitment continues from study initiation in 2024 until the target enrollment is reached or the study ends in 2026. Data are collected in three waves: a baseline survey at the time of admission, administered by an internal researcher by telephone or in person; and two follow-up surveys, conducted at approximately 6 and 12 months after discharge through interviews performed by a professional research organization. Across these waves, the registry captures demographic and injury-related characteristics, use of health services, health and functional status, and clinical information; the follow-up waves additionally capture post-discharge health, healthcare utilization, employment, household income, and social participation. Data are drawn from a combination of patient-reported responses, physician-collected information, and abstraction from medical records. (Eligibility criteria and specific outcome measures are provided in the corresponding sections and are not repeated here.)

Registry procedures and quality factors:

  • Documentation and data dictionary: The full data-collection process is documented in advance, including the protocol, operations and management policies, procedures, data-collection instruments, a complete list of data elements with their definitions, the screening process, the method for generating unique patient registration numbers to prevent duplicate enrollment, and training for data collectors.
  • Roles and responsibilities: Personnel involved in data collection and their specific responsibilities are defined, with clear role assignment.
  • Data validation and quality assurance: Completed questionnaires are reviewed immediately for missing responses or errors, with re-confirmation from the participant when needed, and data are captured using double data entry to ensure accuracy.
  • Data checks: A data management manual is used to review missing values, incorrectly entered values, out-of-range values, and logically impossible values.
  • Source data: Each data element is characterized by whether it derives from a primary or secondary source and whether it is patient-reported, physician-collected, or extracted from medical records.
  • Data storage and security: Identifiable information (e.g., name, resident registration number, patient number) is anonymized and replaced with randomly generated codes, and only coded files are used for analysis. Original data are stored with two-level encryption (file- and sheet-level) on encrypted media kept on a password-protected computer in a locked room, with documented deletion/modification history, a backup plan, and a security plan.
  • Sample size: The planned sample size is 250 participants. A power analysis (G*Power; medium effect size 0.60, two-sided α = 5%, power ≥ 95%) established a required minimum of approximately 100 evaluable participants; enrollment is set at 250 to account for an estimated 20% attrition and to preserve data quality by offsetting loss from missing data.
  • Missing data: Missing, out-of-range, and inconsistent values are addressed through the data management manual, and the planned enrollment of 250 participants helps limit reductions in the analyzable sample due to attrition and missing data.
  • Statistical analysis: Collected data are summarized using descriptive statistics. Comparative analyses (t-tests, analysis of variance, and chi-square tests) examine differences by characteristics such as sex, age group, and injury type-for example, in rehabilitation service utilization and timing of home return at baseline, and in post-discharge healthcare utilization and health outcomes at follow-up.
02

Conditions studied

  • Spinal Cord Injuries (SCI)

Keywords

  • Spinal cord injury
  • Rehabilitation
  • Registry
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's planned enrollment of 250 is above the median of 60 across 332 observational studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with spinal cord injury (SCI), Demographic, injury-related, healthcare utilization, health and functional, and clinical information are collected from patients with spinal cord injury admitted to the National Traffic Injury Rehabilitation Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

[Phase 1(baseline)]

  • Patients admitted with spinal cord injury to the Department of Rehabilitation Medicine at the National Traffic Injury Rehabilitation Hospital
  • Patients able to understand and respond to the study questionnaire without difficulty

[Phases 2 and 3 (follow-up)]

  • Patients who participated in the survey during Phase 1 (i.e., those who had been admitted with spinal cord injury to the Department of Rehabilitation Medicine at the National Traffic Injury Rehabilitation Hospital)
  • Patients who provided consent at the time of the Phase 1 survey and indicated their willingness to take part in the follow-up surveys at approximately 6 months post-discharge (Phase 2) and approximately 12 months post-discharge (Phase 3)

Exclusion criteria

Exclusion Criteria:

  • Patients with a disability that makes participation difficult during administration of the survey
  • Participants otherwise judged by the investigator to be unsuitable for the study
  • Patients who participated in the Phase 1 survey but did not consent to the follow-up surveys in Phases 2 and 3
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Patients with spinal cord injury

    Demographic, injury-related, healthcare utilization, health and functional, and clinical information are collected from patients with spinal cord injury admitted to the National Traffic Injury Rehabilitation Hospital.

06

What researchers measure

Primary outcomes

  1. Level of disability (WHODAS 2.0 total score)

    Level of disability is measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The summary score ranges from 0 to 100, with higher scores indicating greater disability (a worse outcome).

    Time frame: Phase1. Baseline survey (at admission) / Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

Other outcomes

  1. Demographic information

    Name, sex, date of birth, resident registration number, nationality, marital status, education level, region of residence, economic activity (employment) status, occupational category

    Time frame: Phase1. Baseline survey (at admission) / Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

  2. Injury-related information

    Age at injury, date of injury, mode of transfer after injury, place of residence at the time of injury

    Time frame: Phase1. Baseline survey (at admission)

  3. Neurological status (ISNCSCI)

    Neurological impairment classified with the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), reported as the ASIA Impairment Scale (AIS) grade (A = complete to E = normal).

    Time frame: Phase1. Baseline survey (at admission)

  4. Pain intensity (0-10 numeric rating scale)

    Pain intensity measured with a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse pain.

    Time frame: Phase1. Baseline survey (at admission) / Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

  5. Spasticity severity (0-10 numeric rating scale)

    Spasticity severity rated on a 0-10 numeric scale, where 0 indicates no spasticity and 10 indicates the most severe spasticity; higher scores indicate worse spasticity.

    Time frame: Phase1. Baseline survey (at admission) /Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

  6. Functional ambulation (FAC)

    Walking ability classified with the Functional Ambulation Category (FAC), ranging from 0 to 5; higher categories indicate more independent walking (better outcome).

    Time frame: Phase1. Baseline survey (at admission)

  7. Hand function (Jebsen-Taylor Hand Function Test)

    Hand function measured with the Jebsen-Taylor Hand Function Test (JHFT), reported as time to complete the tasks in seconds; shorter time indicates better function.

    Time frame: Phase1. Baseline survey (at admission)

  8. Independence in activities of daily living(SCIM III)

    Functional independence measured with the Korean version of the Spinal Cord Independence Measure III (K-SCIM-III). Total score ranges from 0 to 100; higher scores indicate greater independence (better outcome).

    Time frame: Phase1. Baseline survey (at admission)

  9. Depression (PHQ-9)

    Depressive symptoms measured with the Patient Health Questionnaire-9 (PHQ-9). Total score ranges from 0 to 27; higher scores indicate more severe symptoms (worse outcome).

    Time frame: Phase1. Baseline survey (at admission) / Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

  10. Quality of life (EQ-5D)

    Health-related quality of life measured with the EQ-5D, reported as the EQ-5D index value (range -1 to 1; higher values indicate better health).

    Time frame: Phase1. Baseline survey (at admission) / Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

  11. Post-discharge emergency department visits (number of visits)

    Use of emergency department services after discharge, reported as the number of emergency department visits per participant (self-reported in the follow-up surveys).

    Time frame: Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

  12. Post-discharge hospital admissions (number of admissions)

    Use of inpatient services after discharge, reported as the number of hospital admissions per participant (self-reported in the follow-up surveys).

    Time frame: Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

  13. Post-discharge outpatient visits (number of visits)

    Use of outpatient services after discharge, reported as the number of outpatient visits per participant (self-reported in the follow-up surveys).

    Time frame: Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

  14. Social participation

    Participation in social activities (yes/no) and frequency

    Time frame: Phase2. Follow-up survey 1 (approximately 6 months post-discharge) / Phase3. Follow-up survey 2 (approximately 12 months post-discharge)

07

Study locations

1 of 1 sites recruiting
  • National Traffic Injury Rehabilitation Hospital
    Yangpyeong, Gyeonggi-do 12564, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07901985
Collaborators
National Traffic Injury Rehabilitation Hospital, National Rehabilitation Center, Seoul, Korea
Responsible party
Ja-Ho Leigh (Clinical Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
Oct 28, 2026
Start date
Jul 7, 2024
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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