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临床试验/NCT06632626
NCT06632626已完成不适用

Task-oriented Training on Hand Function in Patients With Taxanes-induced Peripheral Neuropathy

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9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
60
试验地点
1
主要终点
Hand grip strength

研究概览

简要总结

Chemotherapy based on taxanes is commonly used to treat breast cancer. However, chemotherapy-induced peripheral neuropathy (CIPN), a side effect of taxanes, impairs a patient's grip strength, hand dexterity, and upper extremity function which affects quality of life (QOL).

详细描述

Task-oriented training, a type of exercise where exercises are organized into tasks, concentrates on enhancing particular functional abilities through useful, goal-directed activities. So, the purpose of the study to explore the effectiveness of task-oriented training (TOT) on grip strength, hand dexterity and upper extremity function in patients with taxanes-induced peripheral neuropathy.

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 (Participant)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients were females only.
  • •Their ages range from 35 to
  • •All patients suffered from CIPN after using taxanes (anti-cancer agent causing neurotoxic effect).
  • •Diagnosis of CIPN was determined based on symptom history or the presence of stocking glove pattern "distal dysesthesias, pain and numbness" beginning after taxanes intake.
  • •All patients enrolled to the study had their informed consent.
  • •Patients suffer from affected brachial plexus.

排除标准

  • •Patients had pain or numbness in the upper extremity due to other reasons like trauma (fracture), CNS diseases (cerebral infarction), other diseases with neurological symptoms like (diabetes, rheumatoid arthritis or cervical myelopathy).
  • •Patients had bone, brain or spinal cord metastases.
  • •Patients who had history of psychiatric disorders like: depression and schizophrenia or cognitive decline that may hinder them from active participation in the study.
  • •Patients exhibited only acute neuropathy like in patients using oxaliplatin.
  • •Exclusion Criteria:
  • •Patients had pain or numbness in the upper extremity due to other reasons like trauma (fracture), CNS diseases (cerebral infarction), other diseases with neurological symptoms like (diabetes, rheumatoid arthritis or cervical myelopathy).
  • •Patients had bone, brain or spinal cord metastases.
  • •Patients who had history of psychiatric disorders like: depression and schizophrenia or cognitive decline that may hinder them from active participation in the study.
  • •Patients exhibited only acute neuropathy like in patients using oxaliplatin

研究组 & 干预措施

Task oriented training group

Experimental

This group included 30 patients suffering from taxanes induced peripheral neuropathy who received 30 minutes of task-oriented exercises, three sessions per week for four weeks along with 30 minutes of the traditional physical therapy.

干预措施: Task oriented training exercises (Other)

Task oriented training group

Experimental

This group included 30 patients suffering from taxanes induced peripheral neuropathy who received 30 minutes of task-oriented exercises, three sessions per week for four weeks along with 30 minutes of the traditional physical therapy.

干预措施: Traditional physical therapy (Other)

Traditional physical therapy group

Active Comparator

This group included 30 patients suffering from taxanes induced peripheral neuropathy who received 30 minutes of the traditional physical therapy only, three sessions per week for four weeks.

干预措施: Traditional physical therapy (Other)

结局指标

主要结局

Hand grip strength

时间窗: At baseline and after four weeks of intervention.

Hand grip strength (HGS) was measured in the dominant hand for each patient using The CAMRY dynamometer

Hand dexterity

时间窗: At baseline and after four weeks of intervention.

The nine-hole peg test was used to assess the hand dexterity

Hand function

时间窗: At baseline and after four weeks of intervention.

Each patient was asked to answer the questions of the six scales in the Arabic version of Michigan hand questionnaire (1- Overall hand function, 2-Activities of Daily Living, 3- Work performance, 4- Pain, 5- Aesthetics, and 6- Satisfaction with hand function)

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

Arwa Reda Hashem

Physical Therapy Specialist

Cairo University

研究点 (1)

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