Patient and Clinician Perceptions of Safe Ambulation and Their Association With Clinical Outcomes in Individuals With Incomplete Spinal Cord Injury: An Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Walking Index in Spinal Cord Injury II
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Walking Index in Spinal Cord Injury II
Time Frame: Baseline (single time point, within 24-month recruitment period)
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.
Secondary Outcomes
- 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))
- World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)(Baseline (single time point, within 24-month recruitment period))
- Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)(Baseline (single time point, within 24-month recruitment period))
- Timed Up and Go Test(Baseline (single time point, within 24-month recruitment period))
- 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))
- RHDS/SF(Baseline (single time point, within 24-month recruitment period))
- Acceptance and Action Questionnaire - II (AAQ-II)(Baseline (single time point, within 24-month recruitment period))
- Spinal Cord Lesion-Related Coping Strategies Questionnaire (SCLCSQ)(Baseline (single time point, within 24-month recruitment period))
- P1 - Fear of falling during daily ambulation with preferred assistive device/orthosis (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- P2 - Perceived risk of falling during daily ambulation with preferred assistive device/orthosis (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- P3 - Perceived overall mobility compared to self-perceived maximum potential (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- P4 - Degree of use of the most appropriate assistive device/orthosis during upright daily activities (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- P5 - Comfort when using assistive devices/orthoses for walking or standing (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- P6 - Perceived difficulty when using assistive devices/orthoses for walking or standing (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- P7 - Fatigue after using assistive devices/orthoses for 30-40 minutes in a single session (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- P8 - Proportion of upright daily activities performed with walking aids (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- P9 - Proportion of upright daily activities performed with seating aids (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- P10 - Average daily hours spent standing (self-reported)(Baseline (single time point, within 24-month recruitment period))
- P11 - Average daily hours spent sitting (self-reported)(Baseline (single time point, within 24-month recruitment period))
- P12 - Average daily hours spent lying down (self-reported)(Baseline (single time point, within 24-month recruitment period))
- P14 - Assistive device/orthosis planned for use in indoor ambulation after hospital discharge (Walking Index for Spinal Cord Injury II adapted categorical item)(Baseline (single time point, within 24-month recruitment period))
- P15 - Assistive device/orthosis planned for use in outdoor ambulation after hospital discharge (Walking Index for Spinal Cord Injury II adapted categorical item)(Baseline (single time point, within 24-month recruitment period))
- P16 - Type of assistive device/orthosis used for outdoor ambulation over short distances during therapy (Walking Index for Spinal Cord Injury II adapted categorical item)(Baseline (single time point, within 24-month recruitment period))
- P17 - Number of falls within the past year in therapy and non-therapy settings (self-reported count)(Baseline (single time point, within 24-month recruitment period))
- P18 - Number of near-fall incidents within the past year in therapy and non-therapy settings (self-reported count)(Baseline (single time point, within 24-month recruitment period))
- P19 - Assistive device/orthosis expected to be used in daily life after discharge (Walking Index for Spinal Cord Injury II adapted categorical item)(Baseline (single time point, within 24-month recruitment period))
- T1 - Perceived patient's fall risk during daily ambulation with preferred assistive device/orthosis (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- T2 - Overall mobility compared to the patient's maximum potential (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- T3 - Mobility level compared to a similar person without the injury (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- T4 - Degree of use of the most appropriate assistive device/orthosis during upright daily activities without therapist guidance (Visual Analog Scale)(Baseline (single time point, within 24-month recruitment period))
- T6 - Type of assistive device/orthosis used for outdoor ambulation over short distances during therapy (Walking Index for Spinal Cord Injury II adapted categorical item)(Baseline (single time point, within 24-month recruitment period))
- T7 - Assistive device/orthosis recommended for daily life after discharge (Walking Index for Spinal Cord Injury II adapted categorical item)(Baseline (single time point, within 24-month recruitment period))