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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04712188
Other study ID # 10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date September 30, 2020

Study information

Verified date April 2021
Source Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Turkey Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Supraspinatus tendon thickness 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
Primary 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 Through study completion, an average of 1 month
Primary Acromio-humeral distance 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 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. Through study completion, an average of 1 month
Secondary 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. Through study completion, an average of 1 month
Secondary Cadence 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
Secondary 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. Through study completion, an average of 1 month
Secondary 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. Through study completion, an average of 1 month
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