NCT04712188

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

January 10, 2021

Last Update Submit

April 28, 2021

Conditions

Keywords

spinal cord injurystroke patternultrasonography

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • Shoulder range of motion in the sagittal plane

    Through study completion, an average of 1 month

  • Contact angle

    Through study completion, an average of 1 month

  • Cadence

    Through study completion, an average of 1 month

  • Push phase

    Through study completion, an average of 1 month

  • Recovery phase

    Through study completion, an average of 1 month

Study Arms (4)

Arcing

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

Diagnostic Test: Musculoskeletal ultrasonographyOther: Wheelchair propelling test

Semicirculer

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

Diagnostic Test: Musculoskeletal ultrasonographyOther: Wheelchair propelling test

Single loop

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

Diagnostic Test: Musculoskeletal ultrasonographyOther: Wheelchair propelling test

Double loop

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

Diagnostic Test: Musculoskeletal ultrasonographyOther: Wheelchair propelling test

Interventions

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.

ArcingDouble loopSemicirculerSingle 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

ArcingDouble loopSemicirculerSingle loop

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Nurdan Korkmaz, MD

    Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation Specialist

Study Record Dates

First Submitted

January 10, 2021

First Posted

January 15, 2021

Study Start

June 15, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations