Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients

Sponsor
Tokat Gaziosmanpasa University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05839795
Collaborator
(none)
94
1
1
3
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Assessment study
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Musculoskeletal-related pain [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.

  2. Posture [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.

  3. Spine function [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.

  4. Lumbar impairment [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.

  5. Neck impairment [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.

  6. Musculoskeletal disorder [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.

  7. Fatigue [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.

  8. Quality of life of caregivers [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kırıkkale University Kırıkkale Turkey 71300

Sponsors and Collaborators

  • Tokat Gaziosmanpasa University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Halime Arikan, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier:
NCT05839795
Other Study ID Numbers:
  • 83116987-271
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Halime Arikan, Assistant Professor, Tokat Gaziosmanpasa University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2023