Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients

Stroke Clinical Trial

Official title:

Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839795
• Other study ID #: 83116987-271
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2023
• Source: Tokat Gaziosmanpasa University
• Contact: Halime ARIKAN, PhD
• Phone: +90 546 576 51 32
• Email: halimearikan92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Burden
• Cerebral Palsy
• Musculoskeletal Diseases
• Nervous System Diseases
• Neurologic Disorder
• Orthopedic Disorder
• Pediatric Disorder
• Stroke

Intervention

Other:
• Assessment study
Evaluation of musculoskeletal-related pain, posture, spine function, lumbar and neck regions, musculoskeletal disorder, fatigue, and quality of life

Locations

Country	Name	City	State
Turkey	Kirikkale University	Kirikkale

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 6 month
Primary	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.	through study completion, an average of 6 month
Primary	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.	through study completion, an average of 6 month
Primary	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.	through study completion, an average of 6 month
Primary	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.	through study completion, an average of 6 month
Primary	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.	through study completion, an average of 6 month
Primary	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.	through study completion, an average of 6 month
Primary	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.	through study completion, an average of 6 month