NCT04743830

Brief Summary

In recent publications evaluating scapular kinematics after stroke, it is emphasized that scapular muscles, which affect the performance of upper limbs in daily life, should not be ignored. When the literature is analyzed for these reasons, the studies in which scapular training was added to the treatment plan of upper limb rehabilitation of stroke individuals are inadequate and the existing studies have methodological deficiencies. Also, it is seen that studies which investigate the effects of these exercises on scapular kinematics, the parameters of periscapular muscle thickness and shoulder subluxation are not included. The purpose of this study is to examine the effects of scapular training on scapular kinematics, periscapular muscle thickness, shoulder subluxation and upper extremity functionality in stroke individuals. The study was planned to include 2 groups, 1 treatment and 1 control group. The control group will receive Neurodevelopmental Treatment - Bobath exercises, while the treatment group will receive exercises for the muscles around the scapula in addition to Neurodevelopmental Treatment - Bobath exercises. Muscle thickness of periscapular muscles, shoulder subluxation, 3D scapular kinematics, upper extremity and trunk performance, pain, activities of daily living and quality of life will be assessed before and after 8 weeks treatment program. As a result; effectiveness of scapular training in addition to Neurodevelopmental Treatment and relationship between scapular kinematics, periscapular muscle thickness, shoulder subluxation, and upper extremity performance will be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2021

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

Study Start

First participant enrolled

February 1, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

February 3, 2021

Last Update Submit

August 11, 2025

Conditions

Keywords

StrokeMuscle ThicknessScapula3-D KinematicsUpper Extremity Performance

Outcome Measures

Primary Outcomes (3)

  • Evaluation of Muscle Thickness with Ultrasonography

    The evaluation of muscle thickness of bilateral serratus anterior and lower trapezius muscles with ultrasonography will be performed by a physician using a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK) in resting position. Muscle Thickness would be expressed as centimeters.

    change from baseline in muscle thickness of periscapular muscles at 8 weeks

  • Evaluation of Shoulder Subluxation with Ultrasonography

    The evaluation of shoulder subluxation with ultrasonography will be performed by a physician using a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). It will be performed while the individual is sitting on a chair, the shoulder is in neutral rotation, with the elbow at 90 degrees of flexion and the forearm in pronation. The fore-arms will rest on a pillow placed on the patient's lap. The subluxation would be expressed as centimeters.

    change from baseline in shoulder subluxation at 8 weeks

  • 3-Dimensional Scapular Kinematics

    3-Dimensional Scapular Kinematics will be measured by electromagnetic tracking system (Motion Monitor®, Innovative Sports Training Inc, Chicago) during elevation of the upper extremity on the scapular and sagittal plane and hair combing activity.

    change from baseline in scapular kinematics at 8 weeks

Secondary Outcomes (7)

  • Fugl-Meyer Assessment of Upper Extremity (FMA-UE)

    change from baseline in upper extremity performance at 8 weeks

  • Action Research Arm Test (ARAT)

    change from baseline in upper extremity performance at 8 weeks

  • Trunk Impairment Scale

    change from baseline in trunk performance at 8 weeks

  • Visual Analog Scale

    change from baseline in pain at 8 weeks

  • Modified Barthel Index (MBI)

    change from baseline in performance of activities of daily living at 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

Neurodevelopmental Treatment (Bobath) + Scapular Training Group

Other: Neurodevelopmental Treatment (Bobath) + Scapular Training

Control Group

ACTIVE COMPARATOR

Neurodevelopmental Treatment (Bobath) Group

Other: Neurodevelopmental Treatment (Bobath)

Interventions

The Bobath concept for 40 minutes will be formed according to the needs of the individual and involve the upper limb, trunk and lower limb. It will be performed with 20 minutes scapular training including scapular exercise such as Proprioceptive Neuromuscular Facilitation (PNF), dynamic hug, towel-wall slide, scapular punch exercises etc. 3 days a week for 8 weeks.

Treatment Group

The Bobath concept for 60 minutes will be formed according to the needs of the individual and involve the upper limb, trunk and lower limb. It will be performed 3 days a week for 8 weeks.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral ischemic / hemorrhagic stroke for more than 3 months
  • \> 18 years
  • Mild-moderate upper extremity impairment (FMA≥30)
  • Active shoulder elevation ≥ 90°
  • Shoulder girdle muscles spasticity ≤ 2
  • Mini Mental State Examination score ≥ 24

You may not qualify if:

  • Body Mass Index ≤ 30 kg/m2
  • Having an allergy to adhesive tape
  • Clinical diagnosis of another neurologic disease other than stroke which might effect standing independently
  • Having a history of humerus, clavicle and scapula fracture
  • Having a shoulder surgery such as rotator cuff muscle repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Özge ONURSAL KILINÇ, MSc

    Hacettepe University, Faculty of Physical Therapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

February 1, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations