Spinal Cord Injury (SCI)SCINCT06612112
Trunk Balance and Functional Independence in Individuals With SCI
An observational study of Spinal Cord Injury (SCI), run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the relationship between trunk balance, position sense, wheelchair skills, and functional independence in individuals with thoracic spinal cord injury. It aims to understand how these factors interact and influence daily activities and overall quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury (SCI)
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 10 Mar 2025
- How long will I take part?
- 1 Day
- 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: Individuals with spinal cord injury who are being treated in the Department of Physical Therapy and Rehabilitation at Afyonkarahisar University of Health Sciences Health Application Center and who have thoracic level involvement and can use a manual wheelchair independently.
Who may be able to join
- Being diagnosed with traumatic or nontraumatic spinal cord injury,
- Having a thoracic injury level (T1-T12),
- At least 6 months have passed since the SKY injury,
- To have 90 degrees of shoulder flexion and abduction in both upper extremities,
- Be over 18 years of age,
- To be able to sit in a wheelchair without support and use a manual wheelchair independently,
- Volunteering to participate in the study.
Who cannot join
- Having a systemic disease,
- Report a diagnosis of cardiovascular disease,
- Report musculoskeletal pain or pathology involving the upper extremity,
- Patients with intracardiac defibrillators,
- Presence of open wound.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, Merkez, 03000
About this study
Official title: Investigation of the Relationship Between Trunk Balance and Trunk Position Sense, Wheelchair Skills and Functional Independence in Individuals With Thoracic Spinal Cord Injury
This study investigates the relationship between trunk balance, position sense, wheelchair skills, and functional independence in individuals with thoracic spinal cord injury. It aims to understand how these factors interact and influence daily activities and overall quality of life.
Read the detailed description
Sitting balance and wheelchair transfer activities are crucial for non-ambulatory spinal cord injury (SCI) patients to be able to perform activities of daily living. In addition, a comprehensive assessment of trunk balance is recommended in the literature to predict the risk of falls in these patients and to determine their functional independence. However, no study was found in the literature that included only patients with thoracic level involvement in terms of parameters such as trunk balance, fall risk, postural control abilities, functional activity and independence, which are closely related to the level of injury in patients with SCI. There is a need for a comprehensive evaluation of the patient in terms of trunk control and trunk balance, especially after a SCI defined in the thoracic segment of the medulla spinalis. In this study, male and female individuals between the ages of 18-65 years with SCI with thoracic level involvement who continue their routine treatment at the Neurological Rehabilitation Unit of Afyonkarahisar University of Health Sciences Health Application Center Department of Physical Therapy and Rehabilitation will be included. The aim of the study is to examine the relationship between trunk balance, trunk position sense, wheelchair skills and functional independence status of the participants. The findings to be obtained after the study will be analyzed in patients with SCI at the thoracic level.
- Conditions
- Spinal Cord Injury (SCI)
- Being tested
- No Interventions
- Keywords
- Balance, Functional Independence, Trunk Position Sense, Spinal Cord Injury, Wheelchair Ability
- 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.
No InterventionsOther
No Interventions
| Study group | Role | What they receive |
|---|---|---|
| Thoracic SCI individuals | According to the ASIA (American Spinal Injury Association) Scale criteria, ASIA A patients had a complete lesion; ASIA B, ASIA C and ASIA D patients had an incomplete lesion. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Functional Reach Test
The Modified Functional Reach Test (MFRT) is an assessment tool designed to measure an individual\'s stability and balance by evaluating their ability to reach forward while maintaining a standing position. It involves asking the participant to extend their arm forward as far as possible without moving their feet, with the distance recorded in centimeters. This test helps identify fall risk and assess functional balance, particularly in older adults and individuals with balance impairments.
Measured: Baseline
T-shirt Test
The T-shirt Test is a functional assessment used to evaluate the upper body mobility and coordination of individuals, particularly those with spinal cord injuries or other disabilities. During the test, participants are asked to put on and take off a T-shirt while seated in a wheelchair, which assesses their ability to perform daily activities. It measures aspects such as trunk control, upper limb function, and overall independence, providing insights into the participant\'s ability to manage clothing tasks in real-life situations.
Measured: Baseline
The Trunk Control Test
The Trunk Control Test (TCT) is an assessment tool used to evaluate trunk stability and control in individuals with spinal cord injury (SCI). It involves tasks that assess the ability to maintain balance while seated and perform movements such as reaching, twisting, and turning. The test typically includes three components: static sitting balance, dynamic reaching, and trunk rotation.
Measured: Baseline
Secondary outcomes (3)
Trunk position sense
A digital inclinometer (Baseline Digital Inclinometer) will be used during the measurements. Each participant will be given a practice trial and the measurement will be repeated 3 times after the completion of the practice trial. The test procedure will be performed with the inclinometer fixed at the level of the T4 spinal process followed by active trunk flexion at a 30 degree angle. The participant will be asked to maintain and memorize this position for 5 seconds with eyes open. The participant will then be placed in a neutral position and instructed to repeat the target position with closed eyes as accurately as possible. The patient will be asked to verbally report that they have reached the same position. The absolute values of the difference between the angle values in the position taken by the patient and the 30-degree value will be recorded. Body Reposition Error will be recorded by averaging a total of 3 trials
Measured: Baseline
The Wheelchair Skills Test
The Wheelchair Skills Test (WST) is an assessment designed to evaluate an individualls proficiency in using a wheelchair. It involves a series of tasks that simulate real-life scenarios, such as maneuvering in tight spaces, ascending and descending ramps, and navigating various surfaces.
Measured: Baseline
The Spinal Cord Independence Measure
The Spinal Cord Independence Measure (SCIM III) is a comprehensive tool used to assess functional independence in individuals with spinal cord injuries. It evaluates three main domains: self-care, respiration and sphincter management, and mobility.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Sep 2024
- Primary completion20 Jan 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Kundakçı, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612112
- Sponsor's protocol ID
- 2024/2-25
- Acronym
- SCI
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Trunk Balance and Trunk Position Sense, Wheelchair Skills and Functional Independence in Individuals With Thoracic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06612112
- Acronym / sponsor ID
- SCI / 2024/2-25
- Conditions
- Spinal Cord Injury (SCI)
- Keywords
- Balance, Functional Independence, Trunk Position Sense, Spinal Cord Injury, Wheelchair Ability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 25 Sep 2024 (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 study investigates the relationship between trunk balance, position sense, wheelchair skills, and functional independence in individuals with thoracic spinal cord injury. It aims to understand how these factors interact and influence daily activities and overall quality of life.
Detailed description
Sitting balance and wheelchair transfer activities are crucial for non-ambulatory spinal cord injury (SCI) patients to be able to perform activities of daily living. In addition, a comprehensive assessment of trunk balance is recommended in the literature to predict the risk of falls in these patients and to determine their functional independence. However, no study was found in the literature that included only patients with thoracic level involvement in terms of parameters such as trunk balance, fall risk, postural control abilities, functional activity and independence, which are closely related to the level of injury in patients with SCI. There is a need for a comprehensive evaluation of the patient in terms of trunk control and trunk balance, especially after a SCI defined in the thoracic segment of the medulla spinalis. In this study, male and female individuals between the ages of 18-65 years with SCI with thoracic level involvement who continue their routine treatment at the Neurological Rehabilitation Unit of Afyonkarahisar University of Health Sciences Health Application Center Department of Physical Therapy and Rehabilitation will be included. The aim of the study is to examine the relationship between trunk balance, trunk position sense, wheelchair skills and functional independence status of the participants. The findings to be obtained after the study will be analyzed in patients with SCI at the thoracic level.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic SCI individuals | – | Other: No InterventionsAccording to the ASIA (American Spinal Injury Association) Scale criteria, ASIA A patients had a complete lesion; ASIA B, ASIA C and ASIA D patients had an incomplete lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with spinal cord injury who are being treated in the Department of Physical Therapy and Rehabilitation at Afyonkarahisar University of Health Sciences Health Application Center and who have thoracic level involvement and can use a manual wheelchair independently.
Key inclusion criteria (7 listed)
- Being diagnosed with traumatic or nontraumatic spinal cord injury,
- Having a thoracic injury level (T1-T12),
- At least 6 months have passed since the SKY injury,
- To have 90 degrees of shoulder flexion and abduction in both upper extremities,
- Be over 18 years of age,
Key exclusion criteria (5 listed)
- Having a systemic disease,
- Report a diagnosis of cardiovascular disease,
- Report musculoskeletal pain or pathology involving the upper extremity,
- Patients with intracardiac defibrillators,
- Presence of open wound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNo Interventions | Other | Thoracic SCI individuals |
Primary outcome
Modified Functional Reach Test
Time frame: Baseline
The Modified Functional Reach Test (MFRT) is an assessment tool designed to measure an individual\'s stability and balance by evaluating their ability to reach forward while maintaining a standing position. It involves asking the participant to extend their arm forward as far as possible without moving their feet, with the distance recorded in centimeters. This test helps identify fall risk and assess functional balance, particularly in older adults and individuals with balance impairments.
T-shirt Test
Time frame: Baseline
The T-shirt Test is a functional assessment used to evaluate the upper body mobility and coordination of individuals, particularly those with spinal cord injuries or other disabilities. During the test, participants are asked to put on and take off a T-shirt while seated in a wheelchair, which assesses their ability to perform daily activities. It measures aspects such as trunk control, upper limb function, and overall independence, providing insights into the participant\'s ability to manage clothing tasks in real-life situations.
The Trunk Control Test
Time frame: Baseline
The Trunk Control Test (TCT) is an assessment tool used to evaluate trunk stability and control in individuals with spinal cord injury (SCI). It involves tasks that assess the ability to maintain balance while seated and perform movements such as reaching, twisting, and turning. The test typically includes three components: static sitting balance, dynamic reaching, and trunk rotation.
3 secondary outcomes
Trunk position sense
Time frame: Baseline
The Wheelchair Skills Test
Time frame: Baseline
The Spinal Cord Independence Measure
Time frame: Baseline
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 13 Mar 2025.
- Individual participant dataSharing planned: No
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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 Injury (SCI), run by Afyonkarahisar Health Sciences University 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 7 inclusion and 5 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 13 Mar 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?
Modified Functional Reach Test (time frame: Baseline). The study lists 3 primary outcomes in all. 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 13 Mar 2025.