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

NCT07139652 | Completed

• 1 other identifier: AnkaraCHBilkent-PMR-MSS-05
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries (SCI)

Keywords

Spinal Cord Injury; Walking; Rehabilitation; Self Report; Perception

Outcome Measures

Primary Outcomes (1)

• Walking Index in Spinal Cord Injury II

  Walking Index for Spinal Cord Injury II (WISCI II), which assessed walking independence and the need for assistive devices. Scores ranged from 0 to 20 based on the amount of physical assistance, use of braces, and walking aids required to walk 10 meters. In addition to the measured WISCI II score, patient-rated WISCI II (P13) and therapist-rated WISCI II (T5) levels were recorded to reflect the levels at which the individual and the clinician perceived safe ambulation.

  Baseline (single time point, within 24-month recruitment period)

Secondary Outcomes (34)

• ASIA Lower Extremity Muscle Score

  Baseline (single time point, within 24-month recruitment period)

• Ten-Meter Walking Test

  Baseline (single time point, within 24-month recruitment period)

• Timed Up and Go Test

  Baseline (single time point, within 24-month recruitment period)

• Berg Balance Scale

  Baseline (single time point, within 24-month recruitment period)

• Spinal Cord Independence Measure (SCIM III)

  Baseline (single time point, within 24-month recruitment period)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) with incomplete spinal cord injury (ASIA C or D) at T3 or lower neurological level, admitted to a rehabilitation program. Participants present a range of functional ambulation abilities and use various assistive devices. Both male and female patients with traumatic or non-traumatic etiology are included.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Çankaya, Ankara, 066800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

TU (1)