Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients

April 7, 2025 updated by: Halime ARIKAN, Tokat Gaziosmanpasa University
In this study, musculoskeletal-related pain, posture, spine function, the condition of the low back and neck regions, musculoskeletal system disorders, fatigue, and quality of life will be examined in caregivers of rehabilitation patients.

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.

Detailed Description

There are studies examining musculoskeletal disorders, physical demands and care activities of unpaid caregivers, musculoskeletal pain and related factors in unpaid caregivers of individuals with stroke, the effect of the functional status of stroke individuals on caregiver pain, musculoskeletal pain and related factors in mothers of children with cerebral palsy, musculoskeletal symptoms in caregivers of individuals with stroke, the prevalence of musculoskeletal disorders in caregivers of individuals with disabilities in a rehabilitation center, and the prevalence and characteristics of low back pain in caregivers of individuals with stroke in the literature. However, no study was found in which the musculoskeletal system was comprehensively evaluated in the caregivers of rehabilitation patients and the musculoskeletal system characteristics were compared in the caregivers of individuals with cerebral palsy and stroke. Therefore, musculoskeletal-related pain, posture, spine function, the condition of the low back and neck regions, musculoskeletal system disorders, fatigue, and quality of life will be examined in caregivers of rehabilitation patients in this study.

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.
55

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
      • Kırıkkale, Turkey, 71300
        • Kırıkkale University

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

Yes

Description

Inclusion Criteria:

  • The caregiver of the rehabilitation patient,
  • Can speak, read, write Turkish,
  • Over 18 years old.

Exclusion Criteria:

  • Pregnant,
  • Can't speak, read or write Turkish.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: Caregivers of Rehabilitation Patients
Caregivers of rehabilitation patients, such as those with neurological, pediatric, and orthopedic disorders
Other: Assessment study
Evaluation of musculoskeletal-related pain, posture, spine function, lumbar and neck regions, musculoskeletal disorder, fatigue, and quality of life

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
Musculoskeletal-related pain
Time Frame: through study completion, an average of 6 month
Musculoskeletal related pain will be evaluated with the Numeric Pain Rating Scale. The scale starts with 0 (no pain) and ends with 10 (unbearable pain). A score is obtained by measuring the value marked on the scale in the evaluation.
through study completion, an average of 6 month
Posture
Time Frame: through study completion, an average of 6 month
The New York Posture Evaluation Scale will be used to evaluate the posture of individuals. The scale, which examines the alignment of the body parts in the anatomical position, divides the body into 13 parts and provides the opportunity to evaluate from two different directions (anterior, lateral). Scoring is done in the form of "1", "3", "5". 1 point means severely impaired, 3 points means moderately impaired, and 5 points means proper posture. The total score ranges from 13-65. A high score means good posture.
through study completion, an average of 6 month
Spine function
Time Frame: through study completion, an average of 6 month
The Spine Functions Index is a 25-item scale developed to examine the effect of spine-related symptoms on functionality. Each question is scored as "0", "0.5", and "1". The total score is calculated as a percentage, and a score closer to 100 indicates normal spine functions.
through study completion, an average of 6 month
Lumbar impairment
Time Frame: through study completion, an average of 6 month
The Modified Oswestry Disability Index includes 10 questions about pain intensity, personal care, weight lifting, walking, sitting, standing, sleeping, social life, travel and change in pain over time, each question has 6 options. The individual is asked to choose the one that best describes his/her situation from the options between 0 and 5 points in each question. The highest score is 50 points. An increase in the score indicates an increase in functional limitation, while a decrease in the score indicates an increase in functional level.
through study completion, an average of 6 month
Neck impairment
Time Frame: through study completion, an average of 6 month
The Bournemouth Neck Questionnaire will be used to evaluate individuals in terms of neck pain severity, participation in family and social life, depression, anxiety, kinesiophobia, and ability to cope with pain. It consists of 7 questions in total and each question is scored between 0 and 10. A higher score means more impairment.
through study completion, an average of 6 month
Musculoskeletal disorder
Time Frame: through study completion, an average of 6 month
To assess musculoskeletal discomfort, the Cornell Musculoskeletal Discomfort Questionnaire will be used. The Cornell Musculoskeletal Discomfort Questionnaire collects information on the severity of discomfort as well as the effects of the condition for specific regions of the human body. The survey is also a one-page chart that combines the frequency and intensity of musculoskeletal pain and complaints with work-related impairments for 20 body regions.
through study completion, an average of 6 month
Fatigue
Time Frame: through study completion, an average of 6 month
The fatigue of caregivers will be evaluated with the Fatigue Severity Scale. The person indicates how much he or she agrees with each item by choosing numbers from 1 to 7. 1 means completely disagree, 7 means completely agree. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue.
through study completion, an average of 6 month
Quality of life of caregivers
Time Frame: through study completion, an average of 6 month
Short Form-36 is one of the most common generic measures used to measure quality of life. This scale examines 8 dimensions of health with 36 items, such as physical function, role limitations (due to physical and emotional problems), social function, mental health, vitality (energy), pain and general perception of health. A high score indicates a low quality of life.
through study completion, an average of 6 month

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.
Tokat Gaziosmanpasa 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.
May 1, 2023

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.
February 1, 2024

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.
January 4, 2025

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).
April 18, 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.
April 28, 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.
May 3, 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.
April 8, 2025

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.
April 7, 2025

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.
  • 83116987-271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Researchers involved in the study will have individual data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings