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临床试验/CTRI/2025/01/079215
CTRI/2025/01/079215尚未招募2 期

Institution versus Tele-Rehabilitation based balance training program for Chemotherapy Induced Peripheral Neuropathy in Cancer Population

未提供1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
56
试验地点
1
主要终点
mini BEST test

研究概览

简要总结

TITLE: Institution versus Tele - Rehabilitation based balance training program for Chemotherapy Induced Peripheral Neuropathy in Cancer Population

**INTRODUCTION:**The National Cancer Institute defines cancer as a disease characterized by the uncontrolled division of abnormal cells, which can invade surrounding tissues and spread to other parts of the body known as metastatic cancer. The burden of cancer can be alleviated through early detection, preventive strategies such as lifestyle modifications, and the use of frontline chemotherapeutic agents.Though patients with chemotherapeutic interventions in combating cancer,  may experience a range of adverse side effects that includes peripheral neuropathy as one of the major effect that negatively impacts one’s own bodily function. A complex interplay of physical, neurological, and sensory impairments leads to imbalance that gives rise to a high risk of fall.

**RATIONALE:**Balance training reduces fall risk by enhancing proprioception, training reactive balance, improving muscle strength and coordination. By incorporating balance training into CIPN management, patients can regain confidence in their mobility, reduce their fall risk, and improve overall functional outcomes.

AIM: To assess the effect of institution versus tele - rehabilitation based balance training program in patients with Chemotherapy induced peripheral neuropathy.

OBJECTIVES:

To assess the effect of institution based balance training program in patients with Chemotherapy induced peripheral neuropathy.

To assess the effect of tele - rehabilitation based balance training program in patients with Chemotherapy induced peripheral neuropathy.

To compare the results obtained in all 2 groups.

**OUTCOME MEASURES:**1. 10m walk test - To assess walking speed in m/s. 2. mini BEST test - to assess balance.

PROTOCOL: The intervention was developed using Horak’s theoretical balance framework which describes 6 interacting systems contributing to balance control : Biomechanical Constraints, Staability Limits, Verticality, Anticipatory Postural Adjustments, Postural Adjustments, Sensory Orientation and Stability in Gait.

Individuals will be asked to rate each of the exercise at the end of the session using a ten-part Likert scale (10 being the greatest level of challenge and 1 being no challenge).

Exercise levels will be tailored to each individual and will be progressed to increase challenge level when perceived challenge to balance is  less than 7.

Initially variable surface conditions and later exercises with eyes closed will be performed.

Frequency - Thrice a week for 4 weeks, Intensity – 10 repetitions/exercise, Duration - 45 minutes, Type – Balance Training.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
50.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Individuals diagnosed with cancer assigned to receive a chemotherapeutic regimen and has finished the regimen for at least a month.
  • Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity score must be less than
  • Patients with controlled diabetes mellitus having HBA1c up to 7%.

排除标准

  • Individuals with vision or auditory disorders.
  • Patient with cognitive challenges, MoCA score equal to or more than26.

结局指标

主要结局

mini BEST test

时间窗: Baseline and post 4 weeks of Intervention

次要结局

  • 10m Walk test(Baseline & post 4 weeks of Intervention)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Elizabeth Lobo

Sunandan Divatia School of Science

研究点 (1)

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