NCT06612112

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

March 13, 2025

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 23, 2024

Last Update Submit

March 12, 2025

Conditions

Keywords

BalanceFunctional IndependenceTrunk Position SenseSpinal Cord InjuryWheelchair Ability

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline

Secondary Outcomes (3)

  • Trunk position sense

    Baseline

  • The Wheelchair Skills Test

    Baseline

  • The Spinal Cord Independence Measure

    Baseline

Other Outcomes (1)

  • Frequency of falls

    Baseline

Study Arms (1)

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.

Other: No Interventions

Interventions

No Interventions

Thoracic SCI individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, Merkez, 03000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 25, 2024

Study Start

September 1, 2024

Primary Completion

January 20, 2025

Study Completion

March 10, 2025

Last Updated

March 13, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations