Spinal Cord Injuries (SCI)NCT07139652
Patient and Clinician Perceptions of Safe Ambulation in Incomplete Spinal Cord Injury
An observational study of Spinal Cord Injuries (SCI), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years
- Diagnosis of incomplete spinal cord injury (ASIA C or D) at T3 or lower neurological level
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient and Clinician Perceptions of Safe Ambulation and Their Association With Clinical Outcomes in Individuals With Incomplete Spinal Cord Injury: An Observational Study
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.
Read the 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)
- Keywords
- Spinal Cord Injury, Walking, Rehabilitation, Self Report, Perception
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single time point, within 24-month recruitment period)
Secondary outcomes (34)
ASIA Lower Extremity Muscle Score
Assessment of lower extremity muscle strength using the American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
Measured: Baseline (single time point, within 24-month recruitment period)
Ten-Meter Walking Test
Ten-Meter Walking Test for overground walking speed assessment
Measured: Baseline (single time point, within 24-month recruitment period)
Timed Up and Go Test
Timed Up and Go Test overground walking assessment
Measured: Baseline (single time point, within 24-month recruitment period)
Berg Balance Scale
Berg Balance Scale for balance assessment
Measured: Baseline (single time point, within 24-month recruitment period)
Spinal Cord Independence Measure (SCIM III)
Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment
Measured: Baseline (single time point, within 24-month recruitment period)
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment
Measured: Baseline (single time point, within 24-month recruitment period)
Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)
A questionnaire evaluating user satisfaction with assistive devices in terms of performance and service quality.
Measured: Baseline (single time point, within 24-month recruitment period)
RHDS/SF
The RHDS/SF assessed patients' self-perceived readiness for hospital discharge and ability to manage care needs at home, with scores from 0 to 10 where higher scores indicated greater readiness.
Measured: Baseline (single time point, within 24-month recruitment period)
Acceptance and Action Questionnaire - II (AAQ-II)
The AAQ-II measured psychological flexibility and experiential avoidance using nine items rated from 1 (never true) to 7 (always true), with lower scores indicating greater flexibility.
Measured: Baseline (single time point, within 24-month recruitment period)
Spinal Cord Lesion-Related Coping Strategies Questionnaire (SCLCSQ)
The SCLCSQ assessed coping strategies in individuals with spinal cord injury across three domains-acceptance, social confidence, and fighting spirit-using 12 items rated on a 4-point scale.
Measured: Baseline (single time point, within 24-month recruitment period)
P1 - Fear of falling during daily ambulation with preferred assistive device/orthosis (Visual Analog Scale)
P1 assessed the patient's fear of falling during daily ambulation with their preferred assistive device or orthosis on a 0-100 mm visual analog scale.
Measured: 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)
P2 assessed the patient's perceived risk of falling during daily ambulation with their preferred assistive device or orthosis on a 0-100 mm visual analog scale.
Time Frame: Baseline (single time point, within 24-month recruitment period)
Measured: Baseline (single time point, within 24-month recruitment period)
P3 - Perceived overall mobility compared to self-perceived maximum potential (Visual Analog Scale)
P3 assessed perceived overall mobility compared to the patient's self-perceived maximum potential on a 0-100 mm visual analog scale.
Measured: 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)
P4 assessed the degree to which the most appropriate assistive device or orthosis was used during upright daily activities on a 0-100 mm visual analog scale.
Measured: Baseline (single time point, within 24-month recruitment period)
P5 - Comfort when using assistive devices/orthoses for walking or standing (Visual Analog Scale)
P5 assessed comfort when using assistive devices or orthoses for walking or standing on a 0-100 mm visual analog scale.
Measured: Baseline (single time point, within 24-month recruitment period)
P6 - Perceived difficulty when using assistive devices/orthoses for walking or standing (Visual Analog Scale)
P6 assessed perceived difficulty when using assistive devices or orthoses for walking or standing on a 0-100 mm Visual Analog Scale.
Measured: 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)
P7 assessed fatigue experienced after using assistive devices or orthoses for 30-40 minutes in a single session on a 0-100 mm Visual Analog Scale.
Measured: Baseline (single time point, within 24-month recruitment period)
P8 - Proportion of upright daily activities performed with walking aids (Visual Analog Scale)
P8 assessed the proportion of upright daily activities performed with walking aids on a 0-100 mm Visual Analog Scale.
Measured: Baseline (single time point, within 24-month recruitment period)
P9 - Proportion of upright daily activities performed with seating aids (Visual Analog Scale)
P9 assessed the proportion of upright daily activities performed with seating aids such as wheelchairs on a 0-100 mm Visual Analog Scale.
Measured: Baseline (single time point, within 24-month recruitment period)
P10 - Average daily hours spent standing (self-reported)
P10 recorded the average daily hours spent standing as reported by the patient.
Measured: Baseline (single time point, within 24-month recruitment period)
P11 - Average daily hours spent sitting (self-reported)
P11 recorded the average daily hours spent sitting as reported by the patient.
Measured: Baseline (single time point, within 24-month recruitment period)
P12 - Average daily hours spent lying down (self-reported)
P12 recorded the average daily hours spent lying down as reported by the patient.
Measured: 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)
P14 recorded the assistive device or orthosis planned for indoor ambulation after discharge, adapted from Walking Index for Spinal Cord Injury II categories.
Measured: 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)
P15 recorded the assistive device or orthosis planned for outdoor ambulation after discharge, adapted from Walking Index for Spinal Cord Injury II categories.
Measured: 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)
P16 recorded the type of assistive device or orthosis used for outdoor ambulation over short distances during therapy, adapted from Walking Index for Spinal Cord Injury II categories.
Measured: 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)
P17 recorded the number of falls within the past year in therapy and non-therapy settings as self-reported by the patient.
Measured: 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)
P18 recorded the number of near-fall incidents within the past year in therapy and non-therapy settings as self-reported by the patient.
Measured: 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)
P19 recorded the assistive device or orthosis expected to be used in daily life after discharge, adapted from Walking Index for Spinal Cord Injury II categories.
Measured: 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)
T1 assessed the therapist's perception of the patient's fall risk during daily ambulation with their preferred assistive device or orthosis on a 0-100 mm Visual Analog Scale.
Measured: Baseline (single time point, within 24-month recruitment period)
T2 - Overall mobility compared to the patient's maximum potential (Visual Analog Scale)
T2 assessed the therapist's perception of the patient's overall mobility compared to their maximum potential on a 0-100 mm Visual Analog Scale.
Measured: Baseline (single time point, within 24-month recruitment period)
T3 - Mobility level compared to a similar person without the injury (Visual Analog Scale)
T3 assessed the therapist's perception of the patient's mobility level compared to a similar person without injury on a 0-100 mm Visual Analog Scale.
Measured: 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)
T4 assessed the degree to which the patient used the most appropriate assistive device or orthosis during upright daily activities without therapist guidance, on a 0-100 mm Visual Analog Scale.
Measured: 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)
T6 recorded the type of assistive device or orthosis used for outdoor ambulation over short distances during therapy, adapted from Walking Index for Spinal Cord Injury II categories.
Measured: 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)
T7 recorded the assistive device or orthosis recommended for daily life after discharge, adapted from Walking Index for Spinal Cord Injury II categories.
Measured: Baseline (single time point, within 24-month recruitment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Feb 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139652
- Sponsor's protocol ID
- AnkaraCHBilkent-PMR-MSS-05
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Clinician Perceptions of Safe Ambulation and Their Association With Clinical Outcomes in Individuals With Incomplete Spinal Cord Injury: An Observational Study
- ClinicalTrials.gov ID
- NCT07139652
- Acronym / sponsor ID
- AnkaraCHBilkent-PMR-MSS-05
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- Spinal Cord Injury, Walking, Rehabilitation, Self Report, Perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Diagnosis of incomplete spinal cord injury (ASIA C or D) at T3 or lower neurological level
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
34 secondary outcomes
ASIA Lower Extremity Muscle Score
Time frame: Baseline (single time point, within 24-month recruitment period)
Ten-Meter Walking Test
Time frame: Baseline (single time point, within 24-month recruitment period)
Timed Up and Go Test
Time frame: Baseline (single time point, within 24-month recruitment period)
Berg Balance Scale
Time frame: Baseline (single time point, within 24-month recruitment period)
Spinal Cord Independence Measure (SCIM III)
Time frame: Baseline (single time point, within 24-month recruitment period)
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
Time frame: Baseline (single time point, within 24-month recruitment period)
Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)
Time frame: Baseline (single time point, within 24-month recruitment period)
RHDS/SF
Time frame: Baseline (single time point, within 24-month recruitment period)
Acceptance and Action Questionnaire - II (AAQ-II)
Time frame: Baseline (single time point, within 24-month recruitment period)
Spinal Cord Lesion-Related Coping Strategies Questionnaire (SCLCSQ)
Time frame: Baseline (single time point, within 24-month recruitment period)
P1 - Fear of falling during daily ambulation with preferred assistive device/orthosis (Visual Analog Scale)
Time frame: 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)
Time frame: Baseline (single time point, within 24-month recruitment period)
P3 - Perceived overall mobility compared to self-perceived maximum potential (Visual Analog Scale)
Time frame: 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)
Time frame: Baseline (single time point, within 24-month recruitment period)
P5 - Comfort when using assistive devices/orthoses for walking or standing (Visual Analog Scale)
Time frame: Baseline (single time point, within 24-month recruitment period)
P6 - Perceived difficulty when using assistive devices/orthoses for walking or standing (Visual Analog Scale)
Time frame: 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)
Time frame: Baseline (single time point, within 24-month recruitment period)
P8 - Proportion of upright daily activities performed with walking aids (Visual Analog Scale)
Time frame: Baseline (single time point, within 24-month recruitment period)
P9 - Proportion of upright daily activities performed with seating aids (Visual Analog Scale)
Time frame: Baseline (single time point, within 24-month recruitment period)
P10 - Average daily hours spent standing (self-reported)
Time frame: Baseline (single time point, within 24-month recruitment period)
P11 - Average daily hours spent sitting (self-reported)
Time frame: Baseline (single time point, within 24-month recruitment period)
P12 - Average daily hours spent lying down (self-reported)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (single time point, within 24-month recruitment period)
T2 - Overall mobility compared to the patient's maximum potential (Visual Analog Scale)
Time frame: Baseline (single time point, within 24-month recruitment period)
T3 - Mobility level compared to a similar person without the injury (Visual Analog Scale)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (single time point, within 24-month recruitment period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries (SCI), run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Index in Spinal Cord Injury II (time frame: Baseline (single time point, within 24-month recruitment period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.