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

April 28, 2021 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Shoulder Kinematics and Acute Ultrasonographic Changes in Four Different Stroke Patterns in Manual Wheelchair Users With Spinal Cord Injury

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

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

  • Turkey
      • Ankara, Turkey, 06800
        • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Fourty male manual wheelchair users with spinal cord injury, will be divided into 4 groups according to their stroke patterns (arcing, semicirculer, single loop, and double loop).

Description

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Arcing
10 patients with traumatic spinal cord injury using the "arcing" stroke pattern to propel manual wheelchair
Diagnostic test: 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.
Other: 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
Semicirculer
10 patients with traumatic spinal cord injury using the "semicirculer" stroke pattern to propel manual wheelchair
Diagnostic test: 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.
Other: 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
Single loop
10 patients with traumatic spinal cord injury using the "single loop" stroke pattern to propel manual wheelchair
Diagnostic test: 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.
Other: 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
Double loop
10 patients with traumatic spinal cord injury using the "double loop" stroke pattern to propel manual wheelchair
Diagnostic test: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Supraspinatus tendon thickness
Time Frame: Through study completion, an average of 1 month
Transverse images of the suprasinatus tendon will be performed by using musculoskeletal ultrasonography before and after the wheelchair propelling test
Through study completion, an average of 1 month
Long head of the biceps tendon thickness
Time Frame: Through study completion, an average of 1 month
Longitudinal images of the long head of the biceps tendon will be performed by using musculoskeletal ultrasonography before and after the wheelchair propelling test
Through study completion, an average of 1 month
Acromio-humeral distance
Time Frame: Through study completion, an average of 1 month
Acromio-humeral distance measurements will be performed by using musculoskeletal ultrasonography before and after the wheelchair propelling test
Through study completion, an average of 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Shoulder range of motion in the sagittal plane
Time Frame: Through study completion, an average of 1 month
Shoulder range of motion in the sagittal plane (flexion and extension, degree) will be analyzed using by Kinovea version 0.8.27 motion analysis software.
Through study completion, an average of 1 month
Contact angle
Time Frame: Through study completion, an average of 1 month
Contact angle (angle at which the handrim is held, degree) will be analyzed using by Kinovea version 0.8.27 motion analysis software.
Through study completion, an average of 1 month
Cadence
Time Frame: Through study completion, an average of 1 month
Cadence (number of strokes per minute, stroke number/minute) will be analyzed using by Kinovea version 0.8.27 motion analysis software.
Through study completion, an average of 1 month
Push phase
Time Frame: Through study completion, an average of 1 month
Push phase (time elapsed since the handrim is held until it is released, second) will be analyzed using by Kinovea version 0.8.27 motion analysis software.
Through study completion, an average of 1 month
Recovery phase
Time Frame: Through study completion, an average of 1 month
Recovery phase (time elapsed since the handrim is released until it is held again, second) will be analyzed using by Kinovea version 0.8.27 motion analysis software.
Through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nurdan Korkmaz, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10

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

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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