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临床试验/NCT05382520
NCT05382520已完成不适用

Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年8月1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
入组人数
12
试验地点
2
主要终点
FABS

研究概览

简要总结

Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 and over who suffer from chemotherapy-induced neuropathy (CIPN), according to the patient's report, more than 3 months since the end of the chemotherapy treatment.

排除标准

  • Sensory damage / neuropathy that existed even before the start of chemotherapy
  • Incidents of recurrent falls even before the start of chemotherapy (over 2 falls for 6 months)
  • Central nervous system involvement
  • Major pre-morbid orthopedic lower limb impairment
  • Hebrew language not sufficient for assessment and treatment

研究组 & 干预措施

Explicit sensory retraining for lower extremity in individuals with CIPN

Experimental

Explicit sensory retraining for lower extremity function (pain, sensory, balance, gait). five one-hour sessions, a week apart: Pre-Post assessment sessions with 3 treatment sessions in between. Home exercise assigned.

干预措施: Questionares and practice (Diagnostic Test)

结局指标

主要结局

FABS

时间窗: 2 years

Fullerton Advanced Balance Scale: high function balance test - consisting of 10 activities in both static and dynamic phases; 10-40, higher scores are better.

LEPT

时间窗: 2 years

Lower Extremity Position Test: proprioception detection and quantification

TNAS

时间窗: 2 years

TNAS -Treatment-Induced Neuropathy Assessment Scale. 0-90. higher score = worse status

VAS

时间窗: 2 years

0-100 mm visual scale: self-reporting pain assessment from no pain to worst pain possible. We will ask for current pain and the worst pain during the last week.

Allodynia

时间窗: 2 years

tested by non-painful mechanical stimulation: gentle brushing and monofilament

NSA

时间窗: 2 years

Nottingham Sensory Assessment: sensory detection and discrimination test

Semmes-Weinstein monofilament testing

时间窗: 2 years

tactile detection threshold

TUG

时间窗: 2 years

Timed Up and Go: fall prediction screening test; measures time taken to raise from a chair walking 3 meters and re-sit.

次要结局

未报告次要终点

研究者

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

Rotem Merose

Breast Oncologist

Assaf-Harofeh Medical Center

研究点 (2)

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