NCT06278740

Brief Summary

This study aims to determine the relationship between upper extremity pathologies and demographic data, duration of manual wheelchair use, duration of injury, physical examination and musculoskeletal ultrasound measurements in patients with spinal cord injuries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 5, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2025

Completed
Last Updated

December 8, 2025

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

February 19, 2024

Last Update Submit

December 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of US findings among participants

    Ultrasonographic evaluation of upper extremity shoulder, elbow and wrist pathologies and examination of their relationship with clinical parameters.

    1 day (a single point in time)

Secondary Outcomes (5)

  • Visual Analog Scale (VAS)

    1 day (a single point in time)

  • The Physical Examination of the Shoulder Scale (PESS)

    1 day (a single point in time)

  • The Quick Disability of the Arm, Shoulder, and Hand (Quick DASH)

    1 day (a single point in time)

  • American Spinal Injury Association (ASIA) Impairment Scale

    1 day (a single point in time)

  • The Spinal Cord Independence Measure (SCIM-III)

    1 day (a single point in time)

Study Arms (2)

SCI with Manual Wheelchair Usage

Patients with spinal cord injuries who use manual wheelchairs

Diagnostic Test: Musculoskeletal Ultrasound

SCI without Manual Wheelchair Usage

Patients with spinal cord injuries who do not use manual wheelchairs

Diagnostic Test: Musculoskeletal Ultrasound

Interventions

Upper extremity pathologies of participants with ultrasound

SCI with Manual Wheelchair UsageSCI without Manual Wheelchair Usage

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Spinal cord injuries who use manual wheelchairs and spinal cord injuries who do not use manual wheelchairs, aged between 18-65 years who applied to our clinic will be included in the study.

You may qualify if:

  • Patients who have experienced spinal cord injury, can comply with two-stage verbal commands, voluntarily agree to participate in the study and are medically stable.

You may not qualify if:

  • Tetraplegia
  • A significant comorbid condition such as severe heart disease and uncontrolled hypertension.
  • Cognitive dysfunction
  • Active infection
  • Malignancy
  • History of trauma to the upper extremity
  • Brachial plexus and peripheral nerve injury
  • History of surgery on the upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Afyonkarahisar

Afyonkarahisar, Afyonkarahisar, 0300, Turkey (Türkiye)

Location

Afyonkarahisar Health Sciences University

Afyonkarahisar, Afyonkarahisar, 03100, Turkey (Türkiye)

Location

Related Publications (3)

  • Ata AM, Mete Civelek G, Kara O. Relationship Between Manual Wheelchair Using Skills and Upper Limb Musculoskeletal Disorders in Patients With Spinal Cord Injury: A Musculoskeletal Ultrasonography Study. Am J Phys Med Rehabil. 2023 Nov 1;102(11):959-964. doi: 10.1097/PHM.0000000000002296. Epub 2023 May 23.

    PMID: 37256679BACKGROUND
  • Collinger JL, Fullerton B, Impink BG, Koontz AM, Boninger ML. Validation of grayscale-based quantitative ultrasound in manual wheelchair users: relationship to established clinical measures of shoulder pathology. Am J Phys Med Rehabil. 2010 May;89(5):390-400. doi: 10.1097/PHM.0b013e3181d8a238.

    PMID: 20407304BACKGROUND
  • Vives Alvarado JR, Felix ER, Gater DR Jr. Upper Extremity Overuse Injuries and Obesity After Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2021;27(1):68-74. doi: 10.46292/sci20-00061.

    PMID: 33814884BACKGROUND

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mahmut Sami DOĞANLAR, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR
  • Nuran EYVAZ, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 26, 2024

Study Start

August 5, 2024

Primary Completion

October 4, 2025

Study Completion

October 4, 2025

Last Updated

December 8, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations