Managing chemotherapy induced neuropathy in Cancer patients using ExerGaming

 描述（由申请人提供）：化疗诱导的周围神经病变（CIPN）是癌症化疗最具挑战性和最复杂的并发症之一。虽然CIPN的发生率在药物类别之间变化，但大约30-40%的癌症患者会受到影响。在各种CIPN相关症状中，平衡丧失和行走困难已被确定为福尔斯的主要风险因素。鉴于大量CIPN患者患有 从平衡和步态缺陷来看，还没有充分开发出用于这些缺陷的令人惊讶的适当评估和治疗策略。目前对平衡和步态的评估是基于主观评定量表，这对于估计跌倒风险和调整化疗剂量可能不准确。缺乏客观和临床可行的评估工具。此外，缺乏考虑到特定CIPN的锻炼制度 相关的耸人听闻的缺陷。CIPN患者可能需要独特设计的训练方法来帮助弥补这些缺陷。据我们所知，没有CIPN特定的平衡训练计划进行了评估。拟议研究项目的主要创新是应用一种经过验证的可穿戴技术，用于1）客观评估CIPN相关的平衡和步态缺陷，以检查CIPN的发展和严重程度及其与6个月化疗期间平衡和步态变化的相关性; 2）评估基于技术的运动训练改善平衡和步态表现的可行性。该练习提供了基于传感器的交互式界面，包括实时关节运动-来自下肢关节运动的反馈。我们将进行两项临床研究，以验证/评价我们提出的评估和治疗策略。临床研究1是一项纵向研究，我们将评估CIPN与平衡/步态之间的关联，如通过基于可穿戴传感器的评估所测量的。六十（60）名接受神经毒性化疗的癌症患者将在6个月内每两个月接受一次步态和平衡评估。此外，将获得通过振动感知阈值（VPT）测试和临床检查量化的CIPN的发展和严重程度，并将监测跌倒发生率。临床研究2是一项双盲随机对照试验，用于评估基于创新技术的运动训练计划对改善CIPN患者步态和平衡以及预防福尔斯跌倒的有效性。我们将66名符合条件的确诊CIPN的受试者随机分配到对照组和干预组，并随访6个月。干预组将参加为期6周的平衡训练计划，使用拟议的技术，每周两次在他们的家中。控制组将被指示完成一个监督验证程序的非技术家庭为基础的练习每周两次，为期六周。我们将根据干预前后评估的平衡、步态、生活质量、体力活动和跌倒风险的可量化变化，比较各组之间干预的有效性。

 DESCRIPTION (provided by applicant): Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most challenging and complex complications of cancer chemotherapy. Although incidence of CIPN varies among drug class, approximately 30-40% of cancer patients will be affected. Among various CIPN-related symptoms, loss of balance and walking difficulty have been identified as leading risk factors for falls. Given the high number of CIPN patients suffering from balance and gait deficits, surprisingly appropriate assessment and treatment strategies for these deficits have not been adequately developed. Current assessment of balance and gait is based on subjective rating scales which may not be accurate for estimation of fall risk and adjustment of chemotherapy dosage. Objective and clinically feasible assessment tools are lacking. Additionally, there is a lack of exercise regimes that take into account the specific CIPN related sensational deficits. CIPN patients may require uniquely designed training approaches to help compensate for these deficits. To our knowledge, no CIPN-specific balance training program has been evaluated. The primary innovation of the proposed research project is the application of a validated, wearable technology for 1) objectively assessing CIPN-related balance and gait deficits to examine the development and severity of CIPN and its association with changes in balance and gait during a period of 6 months chemotherapy treatment; and 2) evaluate the feasibility of a technology-based exercise training for improving balance and gait performance. The exercise provides an interactive sensor-based interface including real-time joint movement- feedback from lower extremity joint motion. We will conduct two clinical studies for validating/ evaluating our proposed assessment and treatment strategy. Clinical study 1 is a longitudinal study in which we will evaluate the association between CIPN and balance/ gait as measured by wearable sensor-based assessment. Sixty (60) cancer patients receiving neurotoxic chemotherapy will undergo assessment of gait and balance every two months over a period of 6 months. Additionally, development and severity of CIPN as quantified by Vibratory Perception Threshold (VPT) test and clinical examination will be obtained and fall occurrence will be monitored. Clinical study 2 is a double blinded randomized controlled trial for evaluating the effectiveness of an innovative technology-based exercise training program for improving gait and balance, and preventing falls in CIPN patients. We will randomly assign 66 eligible subjects with confirmed CIPN into a control group and intervention group and follow them for six months. The intervention group will take part in a 6-week balance training program using the proposed technology twice per week in their home. Control group will be instructed to complete a supervised validated program of non-technology home-based exercises twice per week for six weeks. We will compare the effectiveness of the intervention between groups based on quantifiable changes in balance, gait, quality of life, physical activity and risk of falling betwen pre- and post-intervention assessments.