NCT05839795

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2025

Completed
Last Updated

April 8, 2025

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

April 18, 2023

Last Update Submit

April 7, 2025

Conditions

Keywords

PainCaregiverLow backNeckMusculoskeletal system

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Caregivers of Rehabilitation Patients

OTHER

Caregivers of rehabilitation patients, such as those with neurological, pediatric, and orthopedic disorders

Other: Assessment study

Interventions

Evaluation of musculoskeletal-related pain, posture, spine function, lumbar and neck regions, musculoskeletal disorder, fatigue, and quality of life

Caregivers of Rehabilitation Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, 71300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver BurdenStrokeCerebral PalsyNervous System DiseasesMusculoskeletal DiseasesPain

Interventions

Outcome Assessment, Health Care

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Damage, ChronicNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 3, 2023

Study Start

May 1, 2023

Primary Completion

February 1, 2024

Study Completion

January 4, 2025

Last Updated

April 8, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Researchers involved in the study will have individual data.

Locations