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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05990413
Other study ID # 26032023
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date December 30, 2024

Study information

Verified date February 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact Çiçek Günday, PT,MSc,PhD-c
Phone +90 507 188 8848
Email cckdmn@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to compare the activity levels of the periscapular (levator scapula, serratus anterior, infraspinatus, upper, middle and lower trapezius) muscles during open and closed kinetic chain activities in individuals with stroke. It is also aimed to reveal the relationship between the timing and percentage of scapular muscle activation, the viscoelastic properties of these muscles, motor performance and capacity. The main questions it aims to answer are: - The activation timing, percentage and viscoelastic properties of the periscapular muscles of stroke individuals compared to healthy individuals; - The activation timing and percentages of periscapular muscles during closed kinetic chain and open kinetic chain activities in stroke individuals; - The relationship between muscle activation timing, muscle activation percentage, viscoelastic properties, upper extremity motor performance and capacity. The study will include both hemiplegic (n=10) and healthy (n=10) participants. All of the participants will be assessed in terms of scapular muscle activation timing and percentage (with superficial electromyography) during both open kinetic chain and closed kinetic chain activities. viscoelastic properties of muscles (Miyoton) will be evaluated. Upper extremity movement frequency and quality (MAG-28) and functional performance (Fugl-Meyer) will be evaluated to reveal the status of stroke individuals. In the study, it is also aimed to reveal the relationship between the timing and percentage of scapular muscle activation, the viscoelastic properties of these muscles, motor performance and capacity. 10 healthy and 10 hemiplegic individuals are planned to participate in the study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 30, 2024
Est. primary completion date August 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Stroke patients will be considered eligible for participation if they: - were at least 6 weeks after stroke (hemorrhagic or ischemic); - had mild to moderate upper limb motor impairment (score of =30 on the Fugl-Meyer upper limb motor part; - had a negative Neer impingement test; - could sit or stand up independently at least 10 minutes. Healthy controls will be considered eligible for participation if they: - had no self-reported shoulder pain; - had a negative Neer impingement test. Exclusion Criteria: Participants will be excluded according to these criteria: - being involuntary to participate and unable to follow the instructions; - being younger than 18 years old; - body mass index equal or higher than 30; - shoulder and/or neck pain in the last six months; - known history of shoulder dislocation, fracture or surgery; - other systemic and/or neurologic diseases. -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle activation timing and percentage Noraxon Surface Electromyography System will be used to assess muscle activation timing and percentage of upper, middle and lower trapezius, serratus anterior, infraspinatus, levator scapulae of all participants. The placement of electrodes will be done according to SENIAM's European Recommendations for Surface Electromyography. Synchronized video capture will be used to determine the phases of the scapular motion during the open and closed kinetic chain exercises (OKC and CKC, respectively). To take the measurement during OKC, participants will be seated in a chair that will support the waist and back, with the feet in contact with the ground. They will be asked to cross the fingers of both hands and to raise both arms overhead as high as they can. For CKC, they will be asked to stand next to a table at level of SIAS and place their forearms on table with the elbows flexed. They will be asked to extend the elbow of the non-measuring arm while shifting body weight to the other side. 1 day
Primary Viscoelastic properties Myoton®PRO Digital Palpation Device will be used to measure the muscle tone, stiffness, and elasticity of muscles below. The patient will be seated with the flexed elbow supported by a pillow next to the body. Measurements will be repeated 3 times.
Upper Trapezius: the end-points of a line connecting the spinous process of C7 and the acromion, distally, from the mid-point of the muscle belly
Middle Trapezius: the mid-point of a line connecting T4 spinous process to the medial border of spina scapula
Lower Trapezius: The mid-point of a line connecting the spinous process of T6 to the medial border of spina scapula
Serratus anterior: a- Over the fourth rib, at the midpoint between the latissimus dorsi and the pectoralis major; b- Over the seventh rib, in the midline of the axilla
Infraspinatus: Two fingers breadth below the center spine of the scapula
Levator Scapulae: Between the posterior margin of SCM and anterior margin of the UT, at level of C4/5
1 day
Secondary Upper extremity motor performance The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It will be used for the participants only with hemiplegia. 1 day
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