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临床试验/NCT07027215
NCT07027215已完成不适用

Impact of Augmented Sensory Feedback on Motor Control and Risk of Falling in Cancer-Related Neuropathic Patients"

Isra University, Jordan2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
improvement of balance which was assessed by fall risk scale

研究概览

简要总结

this research studied the effect of augmented sensory feedback program on motor control and risk of falling in patient with CIPN.

详细描述

Design: A randomized control trial was conducted to investigate the impact of augmented sensory feedback paradigm on motor control and risk of falling in patient with Chemotherapy-induced peripheral neuropathy. Data were collected pre and post treatment from out-patient clinic of the Faculty of Medicine and Faculty of Physical Therapy South Valley University, between January 2023and March 2024. The study was approved by the ethical committee of the Faculty of Physical Therapy, South Vally University, Egypt. The study protocol was explained in detail to every patient and signed written consent was obtained before participation.

Participants: forty female patients with CIPN were recruited from out-patient clinic of the Faculty of Medicine and Faculty of Physical Therapy South Valley University, between January 2023and March 2024.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Forty female with age from 35-60 years
  • •clinically diagnosed with CIPN after recovery from stage I or II breast cancer
  • •The strength at the toes, ankles, knees, and hips, as determined by manual muscle tests, of at least 3/
  • •The patients can walk independently with or without any assistive devices.

排除标准

  • •Patients with a history of hereditary peripheral neuropathy
  • •Diseases that may contribute to peripheral nerve damage, such as diabetes or renal insufficiency, alcohol abuse, HIV, and vasculitis.
  • •Patient who had central or peripheral neurologic disease, brain or spinal cord metastases
  • •Orthopedic problems influencing gait, or foot ulcer at the moment of intake.
  • •Patients with vestibular or neurological problems influencing gait parameters
  • •Subjects who had participated in regular exercise, as defined as 150 min of light-to-moderate intensity exercise per week over the past year, were excluded from this trial.

研究组 & 干预措施

control group 20 Patients"

Active Comparator

Cancer-Related Neuropathic Patients"

干预措施: selected physical therapy program as arm excercises (Combination Product)

study group 20 Patients"

Active Comparator

Cancer-Related Neuropathic Patients"

干预措施: Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF technique (Combination Product)

结局指标

主要结局

improvement of balance which was assessed by fall risk scale

时间窗: one and half month

improvement in feet sensitivity and motor control and risk of falling in both groups in favor of the study group.

Stability measures

时间窗: one and half month

postural stability was measured using a Biodex Balance System SD (950-440 with version 4.X software)

Sensory feedback

时间窗: one and half month

Sensory feedback was assessed by using Semmes-Weinstein monofilament (SWM)

次要结局

未报告次要终点

研究者

发起方
Isra University, Jordan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abeer Abdrabo

Lecture of physical Therapy, Department of Neuromuscular Disorder, Faculty for Physical Therapy, Cairo University, Cairo, Egypt

Isra University, Jordan

研究点 (2)

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