NCT07549217

Brief Summary

Individuals aged 18-65 years who have been clinically diagnosed with spinal cord injury and have developed paraplegia will be included in the study. Demographic and clinical data of the participants, including age, sex, height, weight, etiology of injury, level of injury, duration of injury, and comorbidities, will be recorded. In addition, disease-specific characteristics such as ambulation status, wheelchair use, presence of incontinence, and presence and severity of pain will be assessed. Kinesiophobia levels of the patients will be evaluated using the Tampa Scale for Kinesiophobia (TSK). Functional independence will be assessed using the Spinal Cord Independence Measure-III Self-Report (SCIM-III SR). Fall-related concerns will be evaluated using the Spinal Cord Injury-Falls Concern Scale (SCI-FCS). Pain severity will be assessed using the Visual Analog Scale (VAS), and the presence of neuropathic pain will be evaluated using the DN4 Neuropathic Pain Questionnaire. Symptoms related to anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). All assessments will be conducted through face-to-face interviews. The collected data will be analyzed to investigate the relationship between kinesiophobia and functional independence, fear of falling, pain, and psychological status in individuals with paraplegic spinal cord injury. Validated Turkish versions of all scales used in the study will be employed.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

May 20, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 18, 2026

Last Update Submit

April 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tampa Scale for Kinesiophobia (TSK)

    The TSK is a self-reported questionnaire used to assess fear of movement/re-injury. It consists of 17 items scored on a 4-point Likert scale, with total scores ranging from 17 to 68. Higher scores indicate greater kinesiophobia.

    Baseline

Secondary Outcomes (6)

  • Spinal Cord Independence Measure-III Self-Report (SCIM-III SR)

    Baseline

  • Spinal Cord Injury-Falls Concern Scale (SCI-FCS)

    Baseline

  • Visual Analog Scale (VAS)

    Baseline

  • DN4 Neuropathic Pain Questionnaire

    Baseline

  • Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

    Baseline

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Spinal cord injury patients

You may qualify if:

  • Aged between 18 and 65 years
  • Clinically diagnosed with spinal cord injury
  • Presence of paraplegia
  • Injury duration of at least 3 months (to exclude acute phase effects)
  • Medically stable condition
  • Ability to understand and respond to questionnaires
  • Willingness to participate and provide written informed consent

You may not qualify if:

  • Tetraplegia or other neurological conditions affecting motor function
  • Severe cognitive impairment or psychiatric disorders that may interfere with assessments
  • Presence of active infection, malignancy, or severe systemic disease
  • Severe visual or hearing impairment preventing participation in assessments
  • Current participation in another interventional clinical study
  • Recent surgery or acute medical condition within the last 3 months
  • Incomplete clinical data or inability to complete questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2026

First Posted

April 24, 2026

Study Start (Estimated)

May 20, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04