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临床试验/NCT05212441
NCT05212441Unknown不适用

ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS: A Randomized Controlled Trial

October 6 University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Changes in Total active ROM from baseline to 6 weeks posttreatment

研究概览

简要总结

This study will be done to evaluate effect of applying LED before hand exercise on hand grip strength. Sixty male patients with subacute partial thickness burn of hand will be randomly allocated into two equal groups of 30 patients. The following equipment and tools will be used

Measurement equipments:

  • For total active motion of fingers (TAM): Goniometer.
  • For hand grip strength: Hand grip dynamometer.

Therapeutic equipment:

Light emitting diode therapy (LED) device.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The subject selection will be according to the following criteria:
  • Burn caused by thermal injury (flame or scald) with involvement of the wrist and hand and other parts of the body not including shoulder and elbow.
  • Age range between 20-35 years.
  • Male gender.
  • Subacute Partial-thickness burn " From 3rd day of burn".
  • Recent discharge of in patient acute care, spontaneous healing.
  • All patients enrolled to the study will have their informed consent.

排除标准

  • The potential participants will be excluded if they meet one of the following criteria:
  • Cardiac diseases.
  • Perception of persistent respiratory problem related to a previous inhalation injury
  • Signs of burn infection (i.e., unclear fluid oozing from the wound, increased pain, expanded redness and swelling)
  • Exposed tendons.
  • Nerve, muscle injury.
  • Scar contracture of hand.
  • Cognitive disorders.
  • Presence of fractures.
  • Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
  • Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases will be excluded from the study.

结局指标

主要结局

Changes in Total active ROM from baseline to 6 weeks posttreatment

时间窗: baseline and 6 weeks posttreatment

Total active ROM is the sum of the active metacarpophalangeal (MP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) arc of motion in degrees of an individual digit. The measurement will be performed via a hand-held finger goniometer

Changes in hand grip strength from baseline to 6 weeks posttreatment

时间窗: baseline and 6 weeks posttreatment

A calibrated hydraulic JAMAR (Model: 5030J1, Sammons Preston Rolyan, Chicago, USA), analogue hand-grip dynamometer will be used to measure grip strength. The device provides 1 kg increments on the measurement dial which faces the assessor as mentioned by Clifford et al., 2013.

次要结局

未报告次要终点

研究者

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

Mohamed Magdy Ali Hassan ElMeligie

Principal investigator

October 6 University

研究点 (2)

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