The Effect of Scapular Stabilization Exercises on the Upper Extremity in Patients With Chronic Stroke

February 14, 2024 updated by: Huseyin Atceken, Suleyman Demirel University

Effect of Scapular Stabilization Exercises on Upper Extremity Spasticity and Motor Function in Patients With Chronic Stroke: A Double-Blind Randomized Controlled Study

There is still no approved exact treatment for stroke, one of the leading causes of disability. Neurorehabilitation is an important treatment option for stroke patients with anatomical and functional impairments in their interhemispheric connections. However, special techniques with high effectiveness are being investigated to increase the success of general rehabilitation. In this context, scapula-focused stabilization techniques have been used in stroke patients recently. In this randomized controlled study, investigators aimed to examine the effect of scapular stabilization exercises on upper extremity spasticity and motor function in addition to neurorehabilitation in patients with chronic stroke. 22 chronic stroke patients will be included in the study. The patients will be divided into two groups as scapular exercise group and control group using the simple randomization method. Scapular stabilization exercises will be applied in combination with neurorehabilitation to the first group, while only neurorehabilitation will be applied to the control group. A 6-week (30 sessions) neurorehabilitation program will be applied to all groups, specially planned for the patient. Spasticity of the patients participating in the study Modified Ashworth Scale, upper extremity recovery levels Brunnstrom Recovery Stage, upper extremity functions Fugl Meyer Upper Extremity Scale and Wolf Motor Function Test, independence levels Functional Independence Scale , activities of daily living will be evaluated with the Modified Barthel Index and quality of life will be evaluated with the Stroke Specific Quality of Life Scale. The first evaluation of the patients will be made before the treatment, and each patient will be evaluated after the 6-week exercise program. After all data are collected, in-group and intergroup comparisons will be made.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Isparta, Turkey
        • Hüseyin Atçeken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18
  • 3 months past the stroke history
  • No previous history of stroke
  • Mini mental test score ≥ 24
  • Upper extremity (elbow, wrist and finger) spasticity level to be 1-3 according to Modified Ashworth Scale (MAS)
  • Upper extremity Brunnstrom recovery stage 2-5
  • No botulinum toxin injection for the affected upper extremity in the last 6 months
  • If he is using antispastic medication, his dose has not been changed in the last 1 month.
  • Consent to participate in the study

Exclusion Criteria:

  • Having any neurological, psychiatric, orthopedic, unstable cardiovascular disease other than stroke
  • being pregnant
  • Having upper extremity contractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bobath+ Scapular Stabilization Group
In addition to the Bobath approach, which is one of the neurophysiological treatment methods for the upper extremity, 5 sessions a week for 6 weeks, scapular stabilization exercises will be applied to this group for an additional 6 weeks from the beginning of the treatment. Scapular Stabilization Exercises will be performed with the patient in a sitting position, with the shoulder at 90 degrees and the elbow extended. The patient will be given exercises with isometric contraction while the shoulder is in protraction and retraction by the physiotherapist. Isometric contraction will last for 5 seconds and each exercise will be repeated 2x15 times. There will be a 1-minute rest period between sets. The exercises will be performed in 2 different positions, in the flexion position and in the diagonal position.
Other: Bobath+Scapular Stabilization Exercises
Scapular stabilization exercises will be given to patients in addition to Bobath therapy. It will be applied with the patient in a sitting position, with the shoulder at 90 degrees and the elbow extended. The patient will be given exercises with isometric contraction while the shoulder is in protraction and retraction by the physiotherapist. Isometric contraction will last for 5 seconds and each exercise will be repeated 2x15 times. There will be a 1-minute rest period between sets. The exercises will be performed in 2 different positions, in the flexion position and in the diagonal position.
Active Comparator: Bobath Group
The Bobath approach, one of the neurodevelopmental treatment methods for the upper extremities, was applied to all participants included in the study for 6 weeks, 5 sessions per week. Before starting the Bobath exercises, preparation was made with 10 minutes of stretching and upper extremity mobilization. The Bobath approach included functional exercises that patients could perform at home. Bobath program; shoulder flexion, protraction, abduction and extranal rotation; It included extension of the elbow and wrist, extension and opposition of the fingers. After these exercises, task-specific functional upper extremity exercises were performed with or without an object that could help the treatment. These tasks are; required reaching, grasping, or lifting objects such as a cup, pen, cylindrical box, etc., in different body positions. Each session lasted for 1 hour and at the end of each session, patients were given a home exercise program.
Other: Bobath+Scapular Stabilization Exercises
Scapular stabilization exercises will be given to patients in addition to Bobath therapy. It will be applied with the patient in a sitting position, with the shoulder at 90 degrees and the elbow extended. The patient will be given exercises with isometric contraction while the shoulder is in protraction and retraction by the physiotherapist. Isometric contraction will last for 5 seconds and each exercise will be repeated 2x15 times. There will be a 1-minute rest period between sets. The exercises will be performed in 2 different positions, in the flexion position and in the diagonal position.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brunnstrom Recovery Stage
Time Frame: six weeks
It is a classification method developed to evaluate the upper extremities of patients. Staging used in prognosis follow-up also aims to create a common language among clinicians. For the upper extremity, stage 1 (flash stage), stage 2 (reflexes and spasticity start stage), stage 3 (stage where limb synergies are seen), stage 4 (stage where limb synergies begin to break down), stage 5 (stage where limb synergies are broken except for certain activities) It is a scale that grades impairment between stage 6 (normal motor movement) and stage 6 (normal motor movement).
six weeks
Modified Ashworth Scale
Time Frame: six weeks
It is the most universally accepted clinical tool used to measure the increase in muscle tone. The Ashworth Scale was published in 1964 to assess spasticity in patients with multiple sclerosis. The original Ashworth scale is a 5-point numerical scale that grades spasticity from 0 to 5 (0 without resistance and 5 with one limb rigid in flexion or extension). In 1987, 1+ was added and modified to increase the sensitivity of the Ashworth Scale. Since the scale was modified, Modified Ashworth Scale has been applied as a measure of spasticity in clinical practice and research. The purpose of the Modified Ashworth Scale is to rate muscle tone between 0 (normal muscle tone) and 4 (rigid muscle) points.
six weeks
The Fugl-Meyer Upper Extremity Scale
Time Frame: six weeks
It is a commonly used scale to determine the severity of stroke and measure recovery. Upper extremity sensorimotor impairment after stroke is usually evaluated using The Fugl-Meyer Upper Extremity Scale. It is considered the gold standard. The Fugl-Meyer Upper Extremity Scale is clinically applicable and has excellent reliability, validity and responsiveness. The scale consists of 33 items divided into 4 subscales: shoulder/elbow (18 items), wrist (5 items), hand (7 items) and coordination/speed (3 items). For each item, it is scored as 2 (performs the movement fully), 1 (does the movement partially), and 0 (the movement cannot be performed). A total of 66 points, with higher scores indicating better sensorimotor function.
six weeks
Wolf Motor Function Test
Time Frame: six weeks
The test consists of 17 items. While 15 items evaluate skill and performance time for different functional activities, 2 items evaluate muscle strength. In performance time measurement, a maximum of 120 seconds is given for each of the 15 tasks and the individual is asked to complete the task as soon as possible during this time. All functional movements evaluated 0 = no interference, 1 = interference, 2 = plegia side involved but unable to complete task, 3 = performs task but in synergy pattern or moves very slowly, 4 = performs task near normal but slightly slower than normal; the target may have fine coordination or fluency problems, scored as 5 = doing the task and having normal movement. The average value of the total score is calculated for the functional skill score.
six weeks
Functional Independence Measure
Time Frame: six weeks
It is a reliable assessment of the burden of care acquired due to the assistance patients need in performing a range of activities of daily living. Functional Independence Measure consists of 13-item motor domain (Functional Independence Measure-motor) and 5-item cognitive domain (Functional Independence Measure-cognitive) subcategory. All activities are rated on a seven-point ranking scale ranging from 1 (needs full assistance during activities) to 7 (does the activity completely independently). The Functional Independence Measure motor score ranges from 13 to 91 points, the cognitive score ranges from 5 to 35 points, and the total Functional Independence Measure score ranges from 18 to 126 points. Low scores indicate more addiction.
six weeks
Modified Barthel Index
Time Frame: six weeks
Modified Barthel Index, which is used to measure the independence of patients in activities of daily living, was created by modifying the Barthel Index. It includes 10 items related to activities of daily living (nutrition, personal care, bathing, dressing, bowel and bladder care, toilet use, ambulation, transfers and stair climbing). There are levels between 0 and 5 for each item in Modified Barthel Index. Leveling points are different for each activity. At level 1, the patient is insufficient to perform the activity, while at level 5, the patient can do the activity without assistance, even if slowly. The total score is between 0-100 points. The higher the score, the lower the dependence of the patients on activities of daily living. Modified Barthel Index has good reliability and validity
six weeks
Stroke Specific Quality of Life Scale
Time Frame: six weeks
It is a 49-item scale for 12 subcategories (mobility, vitality, upper extremity functionality, work/productivity, mood, self-care, social roles, family roles, language, vision, thinking, and personality) assessing the independence of stroke patients. It is rated using a 5-point Likert-type scale (1=Totally agree, 2=Somewhat partially agree, 3=Neither agree nor disagree, 4=Partly disagree, 5=Disagree). The higher the score, the better the quality of life of stroke patients.
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suleyman Demirel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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