Patient and Clinician Perceptions of Safe Ambulation in Incomplete Spinal Cord Injury

NCT ID: NCT07139652

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-02-01

Brief Summary

This observational cross-sectional study aims to investigate the relationship between patient and therapist perceptions of safe ambulation and objective clinical outcomes in individuals with incomplete spinal cord injury (iSCI). Adults with iSCI at T3 or lower levels (ASIA C or D) admitted to an inpatient rehabilitation program are assessed for walking status using the Walking Index for Spinal Cord Injury II (WISCI II), including patient-rated and therapist-rated levels. Secondary outcomes include lower extremity muscle strength, gait speed, timed up and go, balance, functional independence, quality of life, fall risk, and assistive device preferences. The study seeks to identify the extent to which patient and therapist perceptions align with objective measures and to explore their associations with fall history and functional outcomes, aiming to improve discharge planning and fall prevention strategies.

Detailed Description

This observational, cross-sectional study was conducted to examine the relationship between perceived and actual safe ambulation levels in individuals with incomplete spinal cord injury (iSCI) and their association with key clinical outcomes. Adult participants (≥18 years) with traumatic or non-traumatic iSCI at T3 or lower levels (ASIA C or D) admitted to an inpatient rehabilitation program were included. Exclusion criteria were inability to provide informed consent or severe cognitive impairment (Mini-Mental State Examination score < 25).

The primary outcome was walking status, assessed using the Walking Index for Spinal Cord Injury II (WISCI II). Both patient-rated (P13) and therapist-rated (T5) WISCI II levels were recorded to capture perceived safe ambulation limits. Secondary outcomes included lower extremity muscle strength (LEMS), 10-Meter Walk Test (10MWT), Timed Up and Go (TUG), Berg Balance Scale (BBS), Spinal Cord Independence Measure III (SCIM III), and WHOQOL-BREF-TR for health-related quality of life. Additional questionnaires assessed fall risk perception, assistive device preferences, readiness for discharge, coping strategies, acceptance and action levels, and assistive technology satisfaction.

Gait parameters were measured on a C-Mill® treadmill platform, including step time, stance phase percentage, stride length, step width, cadence, gait speed, and double support time. Falls and near-fall incidents in the past year were self-reported. Data were analyzed to determine correlations between perception-based and performance-based measures and to explore the relationship between discrepancies in patient and therapist ratings with fall frequency and functional independence.

The study aims to provide evidence to guide clinical decision-making in rehabilitation, optimize discharge planning, reduce fall risk, and improve the integration of patient perspectives into therapy planning for individuals with iSCI.

Conditions

Spinal Cord Injuries (SCI)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Individuals with Incomplete Spinal Cord Injury

Adults (≥18 years) with incomplete spinal cord injury (ASIA C or D) at T3 or lower levels, admitted to an inpatient rehabilitation program. All participants undergo standardized clinical and questionnaire-based assessments, including the Walking Index for Spinal Cord Injury II (WISCI II), patient-rated and therapist-rated ambulation levels, lower extremity muscle strength, gait speed, balance, functional independence, and quality of life. Fall history and assistive device preferences are also recorded. No control group is included.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Diagnosis of incomplete spinal cord injury (ASIA C or D) at T3 or lower neurological level

Exclusion Criteria

• Refusal to participate
• Communication impairment severe enough to prevent obtaining information from the participant (e.g., mental problems, confusion, coma)
• Mini-Mental State Examination score < 25

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AnkaraCHBilkent-PMR-MSS-05

Identifier Type: -

Identifier Source: org_study_id