Effects of Sensorimotor Training on Pain Intensity, Perceived Balance Confidence and Functional Exercise Capacity With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- TUG Test
研究概览
简要总结
Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a prevalent and clinically relevant side effect of chemotherapy in breast cancer patients. It occurs in 30-70% of cases. It can cause various sensory and motor symptoms. Specific exercise interventions have proven promising to target relevant symptoms. Therefore, the objective of this study is to determine the effects of Sensorimotor training on pain intensity, perceived balance confidence, and functional exercise capacity with chemotherapy-induced peripheral neuropathy in breast cancer patients.
详细描述
The study incorporated a single blinded randomized controlled trial conducted at Mayo Hospital, Lahore. It involved 22 participants (N=22) recruited by using non-probability convenience sampling technique according to inclusion criteria and randomly allocated into either of two groups (Experimental group or Control group) using randomizer.org. The participants in experimental group performed sensorimotor training based on progressively challenging balance exercises on unstable surfaces. Participants performed three sets of exercises per session twice a week for 6 weeks, 45 minutes per session. The control group performed conventional exercises such as range of motion, stretching, strengthening, deep breathing and aerobic exercises for 2 times a week for 6 weeks, 45 minutes per session. Pre and post assessment of participants was done on numeric pain rating scale for pain intensity, TUG test for balance, activities-specific balance confidence scale for perceived balance confidence, 6-minute walk test for functional exercise capacity and EORTC QLQ C-30 for quality of life.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with invasive ductal carcinoma, stages I-III
- •Age ranged between 30-65 years
- •3-6 months post breast cancer diagnosis
- •Those who have completed chemotherapy treatment and are medically stable
- •CIPN symptoms as subjectively assessed by FACT/GOG-Ntx. Score ranges from 0-44 (5). 0 - 10: Minimal or no neurotoxicity symptoms, 11 - 20: Mild neurotoxicity symptoms, 21 - 30: Moderate neurotoxicity symptoms, 31 - 40: Severe neurotoxicity symptoms, 41 - 44: Very severe neurotoxicity symptoms
- •For balance testing Fullerton Advanced Balance (FAB) scale was used. 0-19 = high risk of falls, 20-29 = moderate balance impairment, 30-40 = good balance. The cut off value is ≤ 25/40 Points.
- •Objective neurological testing such as Achilles and patellar tendon reflexes (1 = agile, 2 = weak, 3 = missing), peripheral deep sensitivity (0=no sensitivity to 8=highest sensitivity), light touch perception (symmetrical or impaired), sense of position (1 = position recognized, 2 = only position of knee recognized, and 3 = no recognition) and lower leg strength (0 = no activity to 5 = normal force) rated on a Likert-scale
排除标准
- •Women with additional types of cancer besides breast cancer
- •Chronic medical conditions such as poorly controlled diabetes (6)
- •Significant neurological (multiple sclerosis) or cardiopulmonary disease (myocardial infarction < 3 months) that may affect performance (6)
- •Unstable bone metastasis
研究组 & 干预措施
Group A: Experimental Group receiving Sensorimotor Training Exercise.
Participants will undergo sensorimotor training exercises targeting balance, pain reduction, and functional exercise capacity.
干预措施: Sensorimotor Training Exercise (Behavioral)
Group B: Control Group receiving Conventional Exercise Therapy.
Participants will receive conventional exercise therapy as per standard guidelines.
干预措施: Conventional Exercise Therapy (Behavioral)
结局指标
主要结局
TUG Test
时间窗: 6 weeks
It is used to determine the fall risk and measure the progress of balance. Mobility and balance is assessed based on time to complete the test: \< 10 seconds = normal. \< 20 seconds = good mobility \< 30 seconds = walking and balance problems
Numeric Pain Rating Scale (NPRS)
时间窗: 6 weeks
It is a uni-dimensional subjective measure of pain intensity in adults, including those with cancer pain. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.
Activities-Specific Balance Confidence Scale
时间窗: 6 weeks
The ABC-Scale is a self-reported assessment of the participant's level of confidence in static and dynamic balance while doing functional activities
6-Minute Walk Test
时间窗: 6 weeks
The 6-minute walk test (6MWT) is a standardized field test used to predict cardio-respiratory fitness in healthy individuals, as well as to assess functional exercise capacity and responsiveness to rehabilitation treatments in a variety of patient groups
次要结局
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale(6 weeks)
- EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)(6 weeks)
- Fullerton Advanced Balance Scale (FAB Scale)(6 weeks)