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临床试验/CTRI/2024/07/070454
CTRI/2024/07/070454尚未招募不适用

A Cross-Sectional Study to assess Lipid profile, Body Adiposity, Bone Mineral Density, Functional Status and Activity and Participation in Spinal Cord Injury

Dr Shubham Salwan1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
18
试验地点
1
主要终点
To assess High Density Lipoprotein-Cholesterol (HDL-c) levels in Spinal Cord Injury patients

研究概览

简要总结

To assess Lipid profile, Body Adiposity, Bone Mineral Density, Functional Status and Activity and Participation in Spinal Cord Injury. It is a Cross-sectional Observational Study. High Density Lipoprotein Cholesterol (HDL-c) is taken as primary objective . Other Lipid parameters which are Low Density Lipoprotein Cholesterol (LDL-c), Triglycerides (TG) and Total Cholesterol (TC) are taken as secondary objective. Other secondary objectives like Body adiposity by measuring Body Composition parameters which are percentage Total Body Fat Mass (%FM), Fat Mass Index (FMI), percentage trunk fat to percentage leg fat ratio (%Trunk Fat/%Leg Fat), estimated Visceral Adipose Tissue volume (VAT volume), Lean Mass Index (LMI), Appendicular Lean Mass Index (ALMI) and Bone Mineral Density (BMD), both will be assessed by using DEXA scan; Functional status using Self-Report version of Spinal Cord Independence Measure III (SCIM-SR); Activity and participation  using International Spinal Cord Injury-Activities and Participation Basic Data Set (Version 1.0) in Spinal Cord Injury patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Admitted Spinal Cord Injury Patients to Physical Medicine and Rehabilitation ward (Traumatic and Non-Traumatic Spinal Cord Injury patients) Duration of Injury- at least 3 months following Spinal Cord Injury Patients who are capable of or willing to give informed consent Patients comprehend English language.

排除标准

  • Pregnancy and Lactation History of recent fracture in upper limb or lower limb Clinical suspicion with radiological confirmation of Heterotopic Ossification Patients with history of earlier bone loss like pagets disease, hyperparathyroidism, osteoporosis Patients with history of Myocardial Infarction or Coronary Artery Disease Patients not willing to give informed consent.

结局指标

主要结局

To assess High Density Lipoprotein-Cholesterol (HDL-c) levels in Spinal Cord Injury patients

时间窗: At Baseline

次要结局

  • 1) To assess other Lipid profile parameters {Low Density Lipoprotein-Cholesterol, Triglycerides, Total Cholesterol} in Spinal Cord Injury patients(2) To assess Body Composition parameters which are percentage total Body Fat Mass , Fat Mass Index, percentage trunk fat to percentage leg fat ratio, estimated Visceral Adipose Tissue volume, Lean Mass Index, Appendicular Lean Mass Index by using Dual Energy X-ray Absorptiometry scan in Spinal Cord Injury patients)

研究者

发起方
Dr Shubham Salwan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shubham Salwan

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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