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临床试验/NCT07206654
NCT07206654已完成不适用

A Case-Control Study on the Presence, Causes, and Frequencies of Shoulder Girdle Musculoskeletal Complaints in Geriatrics With Diminished Vision

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Prevalence of Shoulder Girdle Pain

研究概览

简要总结

This case-control study aims to investigate the prevalence and determinants of shoulder girdle musculoskeletal complaints (pain, spasm, stiffness, range of motion impairments) in geriatric patients (aged 60+) with diminished vision (visual acuity <6/60) due to Age-related Macular Degeneration (AMD), compared to a control group of age-matched elderly individuals with normal vision. The study will also assess the impact of these complaints on functional ability (Activities of Daily Living - ADL, Instrumental Activities of Daily Living - IADL) and quality of life using standardized questionnaires.

详细描述

This is an observational, case-control study conducted at the ophthalmology and geriatrics departments of Helwan University Hospitals and Beni-Suef University Hospitals. A total of 100 participants will be enrolled: 50 cases with visually significant AMD and visual acuity <6/60, and 50 controls with normal vision. All participants will undergo a comprehensive assessment including: detailed history taking, full ophthalmic examination (visual acuity, slit-lamp, fundus examination), geriatric assessment (ADL, IADL), and a structured musculoskeletal evaluation of the shoulder girdle and neck. The musculoskeletal evaluation will include assessment of pain (Visual Analog Scale), spasm, stiffness, and active/passive range of motion measured by an orthopedic surgeon using standardized tools like a digital inclinometer. Health-related quality of life will be measured using the Arabic Version of the National Eye Institute Visual Function Questionnaire (ARB-VFQ-25). Statistical analysis will be performed to compare the two groups and identify correlating factors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 60 years or older.
  • For Case Group: Documented diagnosis of Age-Related Macular Degeneration (AMD) with visual impairment (visual acuity < 6/60).
  • For Control Group: Normal vision, free from AMD as diagnosed by fundus examination and Snellen test.

排除标准

  • Musculoskeletal complaints due to Parkinsonism.
  • Musculoskeletal complaints due to Osteoarthritis (OA) or Multiple Sclerosis (MS).
  • Inability to provide informed consent.

结局指标

主要结局

Prevalence of Shoulder Girdle Pain

时间窗: Singleassessmentatenrollment(Day1)

Measure: Proportion of participants reporting shoulder girdle pain (Yes/No), assessed via standardized history and Visual Analog Scale (VAS).

Prevalence of Shoulder Girdle Spasm and Stiffness

时间窗: Singleassessmentatenrollment(Day1)

Measure: Proportion of participants with clinically identified shoulder girdle spasm and stiffness (Yes/No).

次要结局

  • Shoulder and Neck Range of Motion (ROM)(Singleassessmentatenrollment(Day1))
  • Functional Status (ADL and IADL)(Singleassessmentatenrollment(Day1))
  • Vision-Related Quality of Life(Singleassessmentatenrollment(Day1))
  • Reading Performance(Singleassessmentatenrollment(Day1))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Yasser Sayed Saif

Prof of Ophthalmology

Beni-Suef University

研究点 (1)

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