Proprioceptive Awareness in Stroke Patients With Different Trunk Impact Levels

September 20, 2023 updated by: Güler ERTUĞRUL, Suleyman Demirel University

The Relatıonshıp Of Proprıoceptıve Awareness Wıth Balance And Spastıcıty In Patıents Wıth Stroke Wıth Dıfferent Trunk Impact Levels

Trunk control is important for maintaining an upright posture, increasing the quality of movement during dynamic activities, and performing transfer activities safely. Individuals with stroke, which is one of the most common neurological diseases in the world, may have various degrees of trunk affect because the contraction strength of the trunk muscles and their ability to work in harmony with each other are reduced. Depending on the increase in the level of trunk involvement, proprioceptive deterioration, increase in balance problems and deterioration in spasticity characteristics can be observed in patients. However, the relationship between these disorders in individuals with stroke, independent of trunk involvement, has not been defined. Therefore, in this study, we aimed to examine the relationship between proprioceptive awareness and balance and spasticity in stroke patients with different trunk involvement levels. 98 chronic stroke patients will be included in the study. Before the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria. After recording the sociodemographic and clinical characteristics of the participants, the cognitive status of the patients will be evaluated with a mini mental test. Trunk Impairment Scale (TRS) will be used to measure trunk control, which is our independent variable. GBS will be administered by another physiotherapist who is blinded to the study. Participants will be divided into two groups, high and low trunk control, according to the score obtained from the GBS. Spasticity of the participants, Modified Tardiue Scale (MTS), cervical proprioceptive awareness cervical joint error test, lower extremity proprioceptive awareness Proprioception test in Technobody Prokin 252 Isokinetic Balance Platform, balance skills Dynamic and static balance in Tecnobody Prokin 252 Isonkinetic Balance Platform will be evaluated by tests. The patients' quality of life will be evaluated with the stroke-specific quality of life scale. In order to prevent bias, scores obtained from the GBÖ will not be shared with the physiotherapist who performs other tests. All data obtained will be noted on a prepared evaluation form. After all data is collected, intra-group and inter-group comparisons will be made.

Study Overview

Status

Status

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

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.

Detailed Description

According to the inclusion and exclusion criteria, 98 chronic stroke patients will be included in the study. Written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria for the study. After the sociodemographic and clinical characteristics of the participants are recorded, the cognitive status of the patients will be evaluated with a mini mental test. The Trunk Disability Scale (TRS) will be used to measure trunk control, which is our independent variable. GBS will be administered by another physiotherapist who is blinded to the study. Participants will be divided into two groups, high and low trunk control, according to the score they receive from the GBÖ. Scores close to 23 points on the GBS will constitute the group with high trunk control, and those with scores close to 0 will constitute the group with low trunk control. The spasticity of the participants will be evaluated with the Modified Tardiue Scale (MTS), the spasticity of the muscles, and the proprioceptive awareness of the cervical region with the cervical joint error test. Lower extremity proprioceptive awareness will be evaluated with proprioception testing on the Technobody Prokin 252 Isokinetic Balance Platform, and balance skills will be evaluated with dynamic and static balance tests on the Tecnobody Prokin 252 Isonkinetic Balance Platform. The patients' quality of life will be evaluated with a stroke-specific quality of life scale. In order to prevent bias, scores obtained from the GBÖ will not be shared with the physiotherapist performing other tests. All data obtained will be noted on the prepared evaluation form. After all data is collected, intra-group and inter-group comparisons will be made.

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.
Observational

Enrollment (Estimated)

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.
98

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 Contact Backup

Study Locations

  • Turkey
      • Kocaeli, Turkey
        • Recruiting
        • Güler Ertuğrul
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

It will consist of stroke patients who live in Kocaeli province and exhibit a hemiplegic-hemiparetic picture for at least 6 months after the stroke event.

Description

Inclusion Criteria:

  • Volunteering to participate in the study
  • Being between the ages of 35-65
  • Being diagnosed with stroke
  • Having a stroke for the first time
  • Mini Mental Test (MMT) Score ≥ 24
  • Brunnstorm lower extremity stage ≥ 4
  • Being clinically stable

Exclusion Criteria:

  • Mini Mental Score <24 points
  • Having cervical pain of 5 or higher on the visual analog scale
  • Having serious vestibular, auditory and visual problems that affect balance (vertigo, etc.)
  • Having a history of orthopedic surgery for the trunk and lower extremities
  • Presence of an additional neurological disease (MS, Parkinson, Alzheimer's)
  • Having joint rigidity that will prevent proprioceptive evaluation

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Group with High Body Control
This group consists of stroke patients who received 23 or close to 23 points on the trunk impairment scale. In these patients, muscle stiffness, awareness of the sense of balance and position, quality of life will be evaluated and their relationships will be examined.
Other: Patients With Stroke With Different Trunk Impact Levels
Before the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria.Trunk Impairment Scale (TRS) will be used to measure trunk control, which is our independent variable. Scores close to 23 points on the TIS will constitute the group with high trunk control, and those with scores close to 0 will constitute the group with low trunk control. Spasticity of the participants, Modified Tardiue Scale (MTS), cervical proprioceptive awareness cervical joint error test, lower extremity proprioceptive awareness Proprioception test in Technobody Prokin 252 Isokinetic Balance Platform, balance skills Dynamic and static balance in Tecnobody Prokin 252 Isonkinetic Balance Platform will be evaluated by tests. The patients' quality of life will be evaluated with the stroke-specific quality of life scale. All data obtained will be noted on a prepared evaluation form.
Other Names:
  • Group with Low Body Control
  • Group with High Body Control
Group with Low Body Control
This group consists of stroke patients who received 0 points or close to 0 points from the trunk impairment scale. In these patients, muscle stiffness, awareness of the sense of balance and position, quality of life will be evaluated and their relationships will be examined.
Other: Patients With Stroke With Different Trunk Impact Levels
Before the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria.Trunk Impairment Scale (TRS) will be used to measure trunk control, which is our independent variable. Scores close to 23 points on the TIS will constitute the group with high trunk control, and those with scores close to 0 will constitute the group with low trunk control. Spasticity of the participants, Modified Tardiue Scale (MTS), cervical proprioceptive awareness cervical joint error test, lower extremity proprioceptive awareness Proprioception test in Technobody Prokin 252 Isokinetic Balance Platform, balance skills Dynamic and static balance in Tecnobody Prokin 252 Isonkinetic Balance Platform will be evaluated by tests. The patients' quality of life will be evaluated with the stroke-specific quality of life scale. All data obtained will be noted on a prepared evaluation form.
Other Names:
  • Group with Low Body Control
  • Group with High Body Control

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
Trunk impairment scale
Time Frame: 20 minutes
It consists of 3 items with different scoring alternatives. The dynamic sitting balance subscale consists of 10 items with 0 and 1 scoring options. The coordination subscale includes 4 items with different scoring alternatives. Possible compensatory strategies used during the administration of Trunk impairment scale to the patient are also evaluated. After all items have been evaluated 3 times, the best result is recorded as the patient's performance value. A score of 23 from the scale indicates that optimal trunk control is achieved, while a score approaching 0 indicates that trunk control has decreased. Turkish validity and reliability study of Trunk impairment scale in stroke patients Sag et al. Made by.
20 minutes
Modified Tardieu Scale
Time Frame: 25 minutes
Modified Tardieu Scale consists of parameters that evaluate the angle and degree of spasticity. The scale evaluates spasticity at three different speeds in order to evaluate the speed-dependent effect of spasticity. These velocities are defined as V1, V2 and V3 velocities. V1 speed represents the evaluation at the lowest speed and V3 represents the evaluation at the highest speed. In all 3 speeds, the target joints are moved passively within the full range of motion, and the value range at which spasticity is observed is calculated by the goniometer. Spasticity degree is made between 0-4. "0" indicates no spasticity, "4" indicates indefatigable clonus (>10 seconds while mainta)
25 minutes
Evaluation of Proprioceptive Awareness
Time Frame: 30 minutes
Cervical Joint Position Error Test will be applied to evaluate the awareness of the sense that detects neck position. Patients are seated in a chair with back support, 90 cm away from the target board fixed to the wall. Patients are first asked to memorize the position without their head tilting in any direction and try to find the same point after an active head movement. Active head movements include flexion, extension, and right and left rotations. The desired movements are repeated 10 times. After the movement, the horizontal, vertical and global distances of each point returned to the starting point will be recorded. To calculate the test result, the average values of the incorrect distances in centimeters will be calculated.
30 minutes
Evaluation of static and dynamic balance
Time Frame: 15 minutes
To measure balance performance, patients are given a movable balance platform on the Tecnobody Prokin 252 balance platform, powered by air piston servo motors. The patient is raised on the platform that detects the sensitive measurement, which can be both movable and fixed. Thanks to the automatic engine locking function, the system instantly switches from dynamic to static measurement and provides measurement of two different balances with objective results.
15 minutes
Stroke-Specific Quality of Life Scale
Time Frame: 10 minutes
It consists of 12 subsections, including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and work efficiency, and a total of 49 items. In PESS, increasing the total score indicates that the quality of life increases, while decreasing the total score indicates that the quality of life decreases.
10 minutes

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: GÜLER ERTUĞRUL, Süleyman Demirel University Faculty of Health Sciences
  • Study Director: MEHMET DURAY, Süleyman Demirel University Faculty of Health Sciences

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.
September 1, 2023

Primary Completion (Estimated)

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.
February 27, 2024

Study Completion (Estimated)

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, 2024

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).
September 12, 2023

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.
September 12, 2023

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.
September 21, 2023

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.
September 22, 2023

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.
September 20, 2023

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.
September 1, 2023

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.
  • 573

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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