NCT05990413

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

August 4, 2023

Last Update Submit

September 3, 2025

Conditions

Keywords

HemiplegiaScapular musclesMuscle timingMuscle activationKinetic chain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Upper extremity motor performance

    1 day

Study Arms (2)

Hemiplegic Participants

Participants will be evaluated in terms of inclusion criteria, and fugl-meyer upper extremity performance assessment will be applied to eligible patients and it will be clarified whether they can be included. Participants who may be included in the study will fill in the patient demographic information form prepared by the researchers as a face-to-face interview. This form will take approximately 5 minutes, during which time the muscles will be rested. Then, the viscoelastic properties of the determined muscles of the participants will be evaluated. Finally, the participants will be evaluated in terms of the activation timing and percentages of the muscles determined during an open and closed kinetic chain activity. Half of the participants will do the open kinetic chain activity before the closed kinetic chain activity with a five-minute resting period between activities. The others will start with the closed kinetic chain activity first and then the open kinetic chain activity.

Healthy Participants

Participants will be evaluated in terms of inclusion criteria. Eligable participants will fill in the patient demographic information form prepared by the researchers as a face-to-face interview. This form will take approximately 5 minutes, during which time the muscles will be rested. Then, the viscoelastic properties of the determined muscles of the participants will be evaluated. Finally, the participants will be evaluated in terms of the activation timing and percentages of the muscles determined during an open and closed kinetic chain activity. Half of the participants will do the open kinetic chain activity before the closed kinetic chain activity with a five-minute resting period between activities. The others will start with the closed kinetic chain activity first and then the open kinetic chain activity.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The total number of participants participating in the study is planned to be twenty. It is planned that ten of those twenty participants will be healthy as the controls and ten of them will be individuals with hemiplegia as cases.

You may qualify if:

  • 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.

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University Physiotherapy and Rehabilitation Reasearch and Application Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kubra Kardeş, PT,MSc,PhD-c

    Istinye University

    STUDY CHAIR
  • Çiçek Günday, PT,MSc,PhD-c

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Ayse Zengin Alpözgen, PT,MSc,PhD

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

June 1, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations