Managing Chemotherapy Induced Neuropathy in Cancer Patients Using Game-based Exercise
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Gait Speed change from Baseline to 6 weeks, three months and six months
研究概览
简要总结
Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have deficits in sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural control and high fall risk. This study will investigate the acceptability and effect of an interactive motor adaptation balance training program based on wearable sensors for improving balance in older cancer patients with CIPN. Cancer patients with confirmed CIPN will be recruited and will be randomized to either intervention (IG) or control (CG) group and followed for 6 months. The intervention group will take part in a 6-week balance training program twice per week in either their home or in clinic (based on subject preference) under the supervision of a qualified research staff member. This intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. The control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. Changes in balance, gait, and physical activity, and number of falls will be compared pre- and post-intervention, as well as 3 and 6 month post intervention. Investigators hypothesize that patients receiving sensor-based exercise training will benefit more compared to group receiving conventional non-technology home-based training in terms of improving functional performance and reducing falls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients
- •Men or women aged 55 years or older
- •Patients undergoing neurotoxic chemotherapy (agents including platinums, vinca alkaloids, taxanes, proteasome inhibitors and interferons)
- •Confirmed peripheral neuropathy (VPT>25) will be eligible to participate
排除标准
- •Subjects will be excluded if they have undergone surgery in the last 6-8 weeks
- •Have Parkinson's Disease
- •Stroke patients
- •Dementia patients
- •Have an active foot ulcer
- •Have an active infection
- •Lower extremity major amputation
- •Patient is taking medications unrelated to cancer treatment that may affect balance and gait
- •Patient has other medical conditions that may affect their balance and gait
- •Patient is unable to ambulate without assistance.
研究组 & 干预措施
Intervention with game-based exercise
Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks.
干预措施: sensor-based interactive exercise (game-based exercise) (Other)
Intervention without game-based exercise
Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks
干预措施: Intervention without game-based exercise (Other)
结局指标
主要结局
Gait Speed change from Baseline to 6 weeks, three months and six months
时间窗: Baseline, 6 weeks, three months, six months
walking ability is quantified by gait speed.
Balance change from Baseline to 6 weeks, three months and six months
时间窗: Baseline, 6 weeks, three months, six months
balance is quantified by body sway
次要结局
- Fear of falling change from Baseline to 6 weeks(Baseline and 6 weeks)
研究者
Bijan Najafi, PhD
Principal Investigator
Baylor College of Medicine