- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712188
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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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
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 |
Intervention / Treatment |
---|---|
Arcing
10 patients with traumatic spinal cord injury using the "arcing" stroke pattern to propel manual wheelchair
|
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.
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
|
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.
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
|
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.
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
|
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.
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
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
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.
Investigators
- 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.
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)
June 15, 2020
Primary Completion (ACTUAL)
September 30, 2020
Study Completion (ACTUAL)
September 30, 2020
Study Registration Dates
First Submitted
January 10, 2021
First Submitted That Met QC Criteria
January 13, 2021
First Posted (ACTUAL)
January 15, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 28, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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