Traumatic Spinal Cord InjuryNCT04712188
Shoulder Kinematics and Acute Ultrasonographic Changes in Manual Wheelchair Users With Spinal Cord Injury
An observational study of Traumatic Spinal Cord Injury, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Traumatic Spinal Cord Injury
- What is being tested?
- Musculoskeletal ultrasonography and Wheelchair propelling test
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, 06800
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Spinal Cord Injury
- Being tested
- Musculoskeletal ultrasonography, Wheelchair propelling test
- Keywords
- spinal cord injury, stroke pattern, ultrasonography
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal ultrasonographyDiagnostic 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 testOther
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
| Study group | Role | What they receive |
|---|---|---|
| Arcing | 10 patients with traumatic spinal cord injury using the "arcing" stroke pattern to propel manual wheelchair Receives: Diagnostic Test: Musculoskeletal ultrasonography; Other: Wheelchair propelling test | |
| Semicirculer | 10 patients with traumatic spinal cord injury using the "semicirculer" stroke pattern to propel manual wheelchair Receives: Diagnostic Test: Musculoskeletal ultrasonography; Other: Wheelchair propelling test | |
| Single loop | 10 patients with traumatic spinal cord injury using the "single loop" stroke pattern to propel manual wheelchair Receives: Diagnostic Test: Musculoskeletal ultrasonography; Other: Wheelchair propelling test | |
| Double loop | 10 patients with traumatic spinal cord injury using the "double loop" stroke pattern to propel manual wheelchair Receives: Diagnostic Test: Musculoskeletal ultrasonography; Other: Wheelchair propelling test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supraspinatus tendon thickness
Transverse images of the suprasinatus tendon will be performed by using musculoskeletal ultrasonography before and after the wheelchair propelling test
Measured: Through study completion, an average of 1 month
Long head of the biceps tendon thickness
Longitudinal images of the long head of the biceps tendon will be performed by using musculoskeletal ultrasonography before and after the wheelchair propelling test
Measured: Through study completion, an average of 1 month
Acromio-humeral distance
Acromio-humeral distance measurements will be performed by using musculoskeletal ultrasonography before and after the wheelchair propelling test
Measured: Through study completion, an average of 1 month
Secondary outcomes (5)
Shoulder range of motion in the sagittal plane
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.
Measured: Through study completion, an average of 1 month
Contact angle
Contact angle (angle at which the handrim is held, degree) will be analyzed using by Kinovea version 0.8.27 motion analysis software.
Measured: Through study completion, an average of 1 month
Cadence
Cadence (number of strokes per minute, stroke number/minute) will be analyzed using by Kinovea version 0.8.27 motion analysis software.
Measured: Through study completion, an average of 1 month
Push phase
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.
Measured: Through study completion, an average of 1 month
Recovery phase
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.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start15 Jun 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Nurdan Korkmaz, MD, Principal investigator, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712188
- Sponsor's protocol ID
- 10
- Status last verified
- Apr 2021
- First submitted
- 10 Jan 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34741794
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Kinematics and Acute Ultrasonographic Changes in Four Different Stroke Patterns in Manual Wheelchair Users With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04712188
- Acronym / sponsor ID
- 10
- Conditions
- Traumatic Spinal Cord Injury
- Keywords
- spinal cord injury, stroke pattern, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arcing | – | Diagnostic Test: Musculoskeletal ultrasonography, Other: Wheelchair propelling test10 patients with traumatic spinal cord injury using the "arcing" stroke pattern to propel manual wheelchair |
| Semicirculer | – | Diagnostic Test: Musculoskeletal ultrasonography, Other: Wheelchair propelling test10 patients with traumatic spinal cord injury using the "semicirculer" stroke pattern to propel manual wheelchair |
| Single loop | – | Diagnostic Test: Musculoskeletal ultrasonography, Other: Wheelchair propelling test10 patients with traumatic spinal cord injury using the "single loop" stroke pattern to propel manual wheelchair |
| Double loop | – | Diagnostic Test: Musculoskeletal ultrasonography, Other: Wheelchair propelling test10 patients with traumatic spinal cord injury using the "double loop" stroke pattern to propel manual wheelchair |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musculoskeletal ultrasonographyThe 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. | Diagnostic test | Arcing, Double loop, Semicirculer, Single loop |
| Wheelchair propelling testParticipants 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 | Other | Arcing, Double loop, Semicirculer, Single loop |
Primary outcome
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
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
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
5 secondary outcomes
Shoulder range of motion in the sagittal plane
Time frame: Through study completion, an average of 1 month
Contact angle
Time frame: Through study completion, an average of 1 month
Cadence
Time frame: Through study completion, an average of 1 month
Push phase
Time frame: Through study completion, an average of 1 month
Recovery phase
Time frame: Through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 34741794Korkmaz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurdan Korkmaz, MD principal investigator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Spinal Cord Injury, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supraspinatus tendon thickness (time frame: Through study completion, an average of 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04712188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.