- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06612112
Trunk Balance and Functional Independence in Individuals with SCI (SCI)
March 12, 2025 updated by: Yunus Emre Kundakçı, Afyonkarahisar Health Sciences University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
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Afyonkarahisar, Merkez, Turkey, 03000
- Afyonkarahisar Health Sciences University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
No Interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk position sense
Time Frame: Baseline
|
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
|
Baseline
|
|
The Wheelchair Skills Test
Time Frame: Baseline
|
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.
|
Baseline
|
|
The Spinal Cord Independence Measure
Time Frame: Baseline
|
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.
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of falls
Time Frame: Baseline
|
Participants will be asked to retrospectively report the number of falls that have occurred in the previous six months and the amount of previous training they have received in fall prevention and transfer skills.
Using the World Health Organization definition, a fall is defined as "an unintentional fall to the ground, floor or other lower level, excluding an intentional change of position to rest against furniture, walls or other objects"
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Actual)
January 20, 2025
Study Completion (Actual)
March 10, 2025
Study Registration Dates
First Submitted
September 23, 2024
First Submitted That Met QC Criteria
September 23, 2024
First Posted (Actual)
September 25, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 12, 2025
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/2-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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