Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients
Primary Purpose
Caregiver Burden, Stroke, Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Assessment study
Sponsored by
About this trial
This is an interventional other trial for Caregiver Burden focused on measuring Pain, Caregiver, Low back, Neck, Musculoskeletal system
Eligibility Criteria
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.
Sites / Locations
- Kırıkkale UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Caregivers of Rehabilitation Patients
Arm Description
Caregivers of rehabilitation patients, such as those with neurological, pediatric, and orthopedic disorders
Outcomes
Primary Outcome Measures
Musculoskeletal-related pain
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.
Posture
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.
Spine function
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.
Lumbar impairment
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.
Neck impairment
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.
Musculoskeletal disorder
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.
Fatigue
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.
Quality of life of caregivers
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05839795
First Posted
April 18, 2023
Last Updated
September 13, 2023
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT05839795
Brief Title
Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients
Official Title
Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Stroke, Cerebral Palsy, Neurologic Disorder, Pediatric Disorder, Orthopedic Disorder
Keywords
Pain, Caregiver, Low back, Neck, Musculoskeletal system
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caregivers of Rehabilitation Patients
Arm Type
Other
Arm Description
Caregivers of rehabilitation patients, such as those with neurological, pediatric, and orthopedic disorders
Intervention Type
Other
Intervention Name(s)
Assessment study
Intervention Description
Evaluation of musculoskeletal-related pain, posture, spine function, lumbar and neck regions, musculoskeletal disorder, fatigue, and quality of life
Primary Outcome Measure Information:
Title
Musculoskeletal-related pain
Description
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.
Time Frame
through study completion, an average of 6 month
Title
Posture
Description
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.
Time Frame
through study completion, an average of 6 month
Title
Spine function
Description
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.
Time Frame
through study completion, an average of 6 month
Title
Lumbar impairment
Description
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.
Time Frame
through study completion, an average of 6 month
Title
Neck impairment
Description
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.
Time Frame
through study completion, an average of 6 month
Title
Musculoskeletal disorder
Description
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.
Time Frame
through study completion, an average of 6 month
Title
Fatigue
Description
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.
Time Frame
through study completion, an average of 6 month
Title
Quality of life of caregivers
Description
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.
Time Frame
through study completion, an average of 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com
Facility Information:
Facility Name
Kırıkkale University
City
Kırıkkale
ZIP/Postal Code
71300
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Researchers involved in the study will have individual data.
Learn more about this trial
Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients
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