MedDataX Logo

Shoulder Kinematics and Acute Ultrasonographic Changes in Manual Wheelchair Users With Spinal Cord Injury

NCT ID: NCT04712188

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

People who lose function of the lower limb due to spinal cord injury (SCI) need to use their arms for activities of daily life especially during weight-bearing tasks, such as transfers, and manual wheelchair (MWC) propulsion in order to maintain mobility. Persistent use of the upper limbs constitutes biomechanical difficulties, especially in the shoulder joint. The most commonly affected area in the shoulder is supraspinatus and biceps tendon. Four different stoke patterns have been classified in MWC users. Distinct amounts of force may be applied to the shoulder joint during propulsion with different stroke patterns and this can affect the shoulder tendons in different rates. In this study, investigators aimed to evaluate and compare the acute sonographic changes in supraspinatus and biceps tendons after a wheelchair propelling test in MWC users with SCI with different stroke patterns. Also, it is intended to determine the risk factors related to the stroke patterns that may be associated with these sonographic changes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Fourty male MWC users with SCI were will be divided into 4 groups according to their stroke patterns (arcing, semicirculer, single loop, and double loop). Participants will use their own wheelchairs with their preferred stroke pattern for 20 minutes at a speed of 1 m / s on a motorized treadmill for a wheelchair propelling test. Wheelchair propelling videos will be recorded during the test. Shoulder kinematics will be analyzed using Kinovea motion analysis software and stoke pattern will be confirmed. Ultrasonographic assesment of participants' nondominant shoulder will be performed before and after testing procedure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Spinal Cord Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

spinal cord injury stroke pattern ultrasonography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arcing

10 patients with traumatic spinal cord injury using the "arcing" stroke pattern to propel manual wheelchair

Musculoskeletal ultrasonography

Intervention Type DIAGNOSTIC_TEST

The ultrasonographic assesment will be used to examine the supraspinatus tendon thickness, the long head of the biceps brachii tendon thickness and acromio-humeral distance before and after wheelchair propelling test.

Wheelchair propelling test

Intervention Type OTHER

Participants will use their own wheelchairs with their preferred stroke pattern for 20 minutes at a speed of 1 m / s on a motorized treadmill for a wheelchair propelling test. Wheelchair propelling videos will be recorded during the test. Shoulder kinematics will be analyzed using Kinovea motion analysis software and stoke pattern will be confirmed

Semicirculer

10 patients with traumatic spinal cord injury using the "semicirculer" stroke pattern to propel manual wheelchair

Musculoskeletal ultrasonography

Intervention Type DIAGNOSTIC_TEST

The ultrasonographic assesment will be used to examine the supraspinatus tendon thickness, the long head of the biceps brachii tendon thickness and acromio-humeral distance before and after wheelchair propelling test.

Wheelchair propelling test

Intervention Type OTHER

Participants will use their own wheelchairs with their preferred stroke pattern for 20 minutes at a speed of 1 m / s on a motorized treadmill for a wheelchair propelling test. Wheelchair propelling videos will be recorded during the test. Shoulder kinematics will be analyzed using Kinovea motion analysis software and stoke pattern will be confirmed

Single loop

10 patients with traumatic spinal cord injury using the "single loop" stroke pattern to propel manual wheelchair

Musculoskeletal ultrasonography

Intervention Type DIAGNOSTIC_TEST

The ultrasonographic assesment will be used to examine the supraspinatus tendon thickness, the long head of the biceps brachii tendon thickness and acromio-humeral distance before and after wheelchair propelling test.

Wheelchair propelling test

Intervention Type OTHER

Participants will use their own wheelchairs with their preferred stroke pattern for 20 minutes at a speed of 1 m / s on a motorized treadmill for a wheelchair propelling test. Wheelchair propelling videos will be recorded during the test. Shoulder kinematics will be analyzed using Kinovea motion analysis software and stoke pattern will be confirmed

Double loop

10 patients with traumatic spinal cord injury using the "double loop" stroke pattern to propel manual wheelchair

Musculoskeletal ultrasonography

Intervention Type DIAGNOSTIC_TEST

The ultrasonographic assesment will be used to examine the supraspinatus tendon thickness, the long head of the biceps brachii tendon thickness and acromio-humeral distance before and after wheelchair propelling test.

Wheelchair propelling test

Intervention Type OTHER

Participants will use their own wheelchairs with their preferred stroke pattern for 20 minutes at a speed of 1 m / s on a motorized treadmill for a wheelchair propelling test. Wheelchair propelling videos will be recorded during the test. Shoulder kinematics will be analyzed using Kinovea motion analysis software and stoke pattern will be confirmed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Musculoskeletal ultrasonography

The ultrasonographic assesment will be used to examine the supraspinatus tendon thickness, the long head of the biceps brachii tendon thickness and acromio-humeral distance before and after wheelchair propelling test.

Intervention Type DIAGNOSTIC_TEST

Wheelchair propelling test

Participants will use their own wheelchairs with their preferred stroke pattern for 20 minutes at a speed of 1 m / s on a motorized treadmill for a wheelchair propelling test. Wheelchair propelling videos will be recorded during the test. Shoulder kinematics will be analyzed using Kinovea motion analysis software and stoke pattern will be confirmed

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* People with traumatic spinal cord injury
* Age between 18 to 65 years,
* Neurologic injury level at T2 or below, with AIS grade A or B,
* Time since injury at least 6 months,
* Using manual wheelchair as their primary mobility tools

Exclusion Criteria

* Fractures in nondominant upper limb at any time,
* Shoulder surgery within the past 5 years or corticosteroid injections within the past 3 months to the nondominant shoulder,
* Upper limb pain that restricts propulsion of a manual wheelchair,
* A history of cardiopulmonary problems and degenerative joint diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasin Demir

Physical Medicine and Rehabilitation Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nurdan Korkmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Korkmaz N, Yardimci G, Yilmaz B. Temporospatial parameters, shoulder kinematics, and acute tendon changes in four different stroke patterns in male wheelchair users with spinal cord injury. PM R. 2022 Aug;14(8):939-948. doi: 10.1002/pmrj.12733. Epub 2022 Jan 5.

Reference Type DERIVED
PMID: 34741794 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10

Identifier Type: -

Identifier Source: org_study_id