- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05839795
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
55
Phase
- 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 Locations
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Other: Caregivers of Rehabilitation Patients
Caregivers of rehabilitation patients, such as those with neurological, pediatric, and orthopedic disorders
|
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
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
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)
May 1, 2023
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
January 4, 2025
Study Registration Dates
First Submitted
April 18, 2023
First Submitted That Met QC Criteria
April 28, 2023
First Posted (Actual)
May 3, 2023
Study Record Updates
Last Update Posted (Actual)
April 8, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
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