跳至主要内容
临床试验/NCT07532642
NCT07532642招募中不适用

Radiographic Head and Neck Positional Changes in Response to Oculomotor Muscles Tonic Modification Using Low-powered Prismatic Lenses

Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Radiographic modification of pelvic tilt angle

研究概览

简要总结

This study aims to investigate the short-term modifications in head and neck positioning by usage of low-powered prismatic lenses in patients with Postural Deficiency Syndrome (PDS). A matched pair observation study was designed. Evaluation is carried out using low dose biplanar radiography before treatment and 15 minutes after lenses application.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Presentation of diagnostic criteria for Postural Deficiency Syndrome comprising of
  • Two or more cardinal signs of Postural Deficiency Syndrome
  • Clinical presentation of asymmetrical stance and head extension and rotation
  • Presence of typical directional pseudoscotoma described in this syndrome

排除标准

  • Vision under 8/10, strabismus or nistagmus;
  • Previous eye or vestibular surgery;
  • Known disease affecting the central nervous system or inner ear;
  • Medication with known interference with balance and posture and
  • treatment for postural and movement disorders in the previous year.

研究组 & 干预措施

Unique

Experimental

干预措施: Prismatic low-powered lenses (Device)

结局指标

主要结局

Radiographic modification of pelvic tilt angle

时间窗: From enrollment to second radiographic evaluation on day 1

Changes in pelvic tilt angle are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in degrees using the radiographic equipment proprietary software (EOS imaging). A minimum clinical significance value of 3 degrees was estimated.

Radiographic modification of C0 inclination

时间窗: From enrollment to second radiographic evaluation at day 1

Changes in C0 inclination angle are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in degrees using the radiographic equipment proprietary software (EOS imaging). A minimum clinical significance value of 3 degrees was estimated.

Radiographic modification of cervical spinal vertical alignment

时间窗: From enrollment to second radiographic evaluation at day 1

Changes of cervical spinal vertical alignment are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in millimeters using the radiographic equipment proprietary software (EOS imaging). A minimum clinical significance value of 2 millimeters was estimated.

次要结局

  • Radiographic modification of cervical lordosis(From enrollment to second radiographic evaluation at day 1)
  • Radiographic modification of inclination of C1(From enrollment to second radiographic evaluation at day 1)
  • Radiographic modification of inclination of C2(From enrollment to second radiographic evaluation at day 1)
  • Radiographic modification of global spinal vertical alignment(From enrollment to second radiographic evaluation at day 1)

研究者

发起方
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
申办方类型
Network
责任方
Principal Investigator
主要研究者

João Alves da Silva

MD

Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

研究点 (1)

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