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临床试验/NCT06862635
NCT06862635Enrolling By Invitation不适用

Efficacy of Hydrotherapy on Balance in Neuropathic Patients Post-Burn

MTI University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
1
主要终点
Balance assessment (Biodex Balance System)

研究概览

简要总结

Balance problems are common among neuropathic patients following burns, primarily due to sensory and motor impairments.The goal of the study is to investigate the effect of a hydrotherapy program on balance in neuropathic patients following burns. It is a randomized controlled study will be conducted on fifty male patients (age range from 35 to 45 years) with polyneuropathy following lower limb burn injuries, mainly at the sole of the foot, with 3rd-degree injuries and 30% burn extent.

Balance will be assessed before and after treatment using the Biodex Balance System and the Berg Balance Scale (BBS).

Patients will be randomly assigned into two equal groups:

Group A (study group) will receive hydrotherapy sessions including stretching, resistance, and balance exercises in water.

Group B (control group) will receive traditional land-based balance exercises only.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •polyneuropathy following burn injuries of the lower limb mainly at the sole of the foot.
  • •3rd-degree injuries and 30% burn extent.
  • •Patients' ages range from 35 to 45 years,
  • •Ability to understand instructions and following commands.

排除标准

  • •balance disturbances due to neurological disorders other than polyneuropathy (e.g., Parkinson's disease, inner ear disorders, vestibular or cerebellar dysfunctions).
  • •Uncontrolled hypertension.
  • •Diabetes mellitus,
  • •Cognitive impairments
  • •Blindness.
  • •Deafness.
  • •Significant respiratory or cardiac conditions.

研究组 & 干预措施

Hydrotherapy group

Experimental

干预措施: Hydrotherapy (Other)

Land Based exercise group

Active Comparator

干预措施: traditional land-based balance exercises (Other)

结局指标

主要结局

Balance assessment (Biodex Balance System)

时间窗: Balance will be assessed by bode balance system before the first session and after 12 sessions (3 months)

The Biodex Balance System is a multiaxial device that objectively measures and records an individual's ability to stabilize the involved joint under dynamic stress. It uses a circular platform that is free to move in the anterior-posterior and medial-lateral axes simultaneously. It can also be used for the purpose of balance training.

次要结局

  • Balance assessment (Berg Balance Scale)(Berg balance scale will be recorded before the fisrt session and after 12 sessions (3 months))

研究者

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

Radwa Fayek Hammam

Lecturer at faculty of Physical Therapy

MTI University

研究点 (1)

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