Effects of Feedback-Based Balance Training on Balance and Gait Performance in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Balance Performance
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a common complication of cancer treatment that can cause numbness, tingling, pain, balance problems, and difficulty walking. These symptoms may increase the risk of falls and reduce independence and quality of life in cancer survivors.
The purpose of this study is to determine whether adding feedback-based balance training to conventional physiotherapy improves balance and walking ability in cancer patients with CIPN. Participants will be randomly assigned to one of two groups. One group will receive conventional physiotherapy along with feedback-based balance and gait training, while the other group will receive conventional physiotherapy alone.
The intervention will be provided twice per week for four weeks. Balance, gait performance, neuropathy symptoms, and fear of falling will be assessed before and after the intervention using standardized clinical outcome measures. The findings of this study may help identify effective rehabilitation strategies to improve balance and mobility in cancer patients affected by chemotherapy-induced peripheral neuropathy.
详细描述
This study is a single-blind, parallel-group randomized controlled trial designed to evaluate the effects of feedback-based balance training on balance and gait performance in cancer patients with chemotherapy-induced peripheral neuropathy (CIPN).
Eligible participants will be adults aged 30 to 60 years with a diagnosis of breast, rectal, or stomach cancer who have developed peripheral neuropathy following neurotoxic chemotherapy. Participants must be able to walk at least six meters independently and demonstrate clinically relevant neuropathy symptoms as measured by the EORTC CIPN20 questionnaire. Individuals with other causes of peripheral neuropathy, significant neurological disorders, severe visual impairment, or musculoskeletal conditions affecting balance will be excluded.
A total of 70 participants will be recruited and randomly allocated into two groups in a 1:1 ratio. The experimental group will receive conventional physiotherapy combined with feedback-based balance and gait training, while the control group will receive conventional physiotherapy alone. Randomization will be performed using a simple random allocation method. Outcome assessors will be blinded to group allocation.
The intervention will be delivered twice weekly for four weeks, with each session lasting approximately 30 minutes. Feedback-based balance training will include task-oriented balance and gait activities incorporating visual and verbal feedback, mirror-based exercises, and functional gait tasks designed to challenge postural control and coordination. Conventional physiotherapy will include strengthening, flexibility, and general balance exercises.
Outcome measures will be assessed at baseline and immediately after completion of the four-week intervention. Primary outcomes include balance performance measured using the Berg Balance Scale and gait performance measured by walking speed. Secondary outcomes include neuropathy-related symptoms assessed using the EORTC CIPN20 questionnaire and fear of falling assessed using the Falls Efficacy Scale-International (FES-I).
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to group allocation by providing both groups with supervised physiotherapy sessions of similar duration and structure, without disclosure of group-specific intervention details. Outcome assessors will be blinded to treatment allocation. Due to the nature of the intervention, care providers delivering the physiotherapy cannot be blinded.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 30 to 60 years
- •Diagnosed with breast, rectal, or stomach cancer
- •History of treatment with neurotoxic chemotherapy
- •Presence of chemotherapy-induced peripheral neuropathy as indicated by an EORTC CIPN20 total score of 24 or higher
- •Ability to walk independently for at least 6 meters, with or without an assistive device
- •Medically stable and able to participate in physiotherapy
排除标准
- •Peripheral neuropathy due to causes other than chemotherapy (e.g., diabetes mellitus)
- •History of neurological disorders affecting balance or gait (e.g., stroke, Parkinson's disease)
- •Severe musculoskeletal conditions affecting balance or lower limb function
- •Active foot ulcers, infections, or soft tissue injuries
- •Severe visual impairment affecting balance
- •Any medical condition that, in the investigator's judgment, would interfere with safe participation
研究组 & 干预措施
Feedback-Based Balance Training Plus Conventional Physiotherapy
Participants in this arm will receive conventional physiotherapy combined with feedback-based balance and gait training. Conventional physiotherapy will include strengthening, flexibility, and general balance exercises. Feedback-based balance training will consist of task-oriented balance and gait activities incorporating visual and verbal feedback, mirror-based exercises, and functional gait tasks designed to challenge postural control and coordination. Sessions will be supervised, last approximately 30 minutes, and will be conducted twice per week for four weeks.
干预措施: Feedback-Based Balance and Gait Training (Other)
Conventional Physiotherapy
Participants in this arm will receive conventional physiotherapy focused on strengthening, flexibility, and general balance exercises commonly used in the rehabilitation of patients with peripheral neuropathy. Sessions will be supervised, last approximately 30 minutes, and will be conducted twice per week for four weeks.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Balance Performance
时间窗: Baseline and immediately after completion of the 4-week intervention
Balance performance will be evaluated using the Berg Balance Scale (BBS), a 14-item standardized clinical assessment with total scores ranging from 0 to 56, where higher scores indicate better balance.
次要结局
- Gait Performance(Baseline and immediately after completion of the 4-week intervention)
- Chemotherapy-Induced Peripheral Neuropathy Symptoms(Baseline and immediately after completion of the 4-week intervention)
研究者
Amna Zia
Physiotherapist/ Lecturer
King Edward Medical University