Comparative Effects of Tai Chi Versus Modified-Otago Exercises On Pain, Balance And Motor Function In Patients With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
his randomized clinical trial evaluates the comparative effectiveness of Tai Chi and Modified-Otago exercise programs on pain reduction, balance improvement, and motor function in patients diagnosed with diabetic peripheral neuropathy (DPN). DPN is a common complication of Type 2 Diabetes Mellitus that significantly impairs quality of life through chronic pain, balance deficits, and decreased functional mobility. While pharmacological treatments are commonly used, they often result in adverse side effects, creating a growing need for non-pharmacological interventions like therapeutic exercises.
Tai Chi, a traditional Chinese exercise combining slow movements and mental focus, has shown benefits in improving mobility and reducing fall risks in chronic disease populations. The Modified-Otago program, originally developed to prevent falls in the elderly, emphasizes strength and balance training through structured exercise routines.
A total of 36 participants (aged 40-80 years) with at least a 5-year history of Type 2 diabetes and a minimum pain score of ≥3 on the Numeric Pain Rating Scale (NPRS) will be recruited. Participants will be randomly allocated to either the Tai Chi group or the Modified-Otago group. Both groups will receive 24 sessions over an 8-week period (3 sessions per week), along with baseline interventions such as heating pad application, TENS, and warm-up/cool-down routines.
Primary outcome measures include NPRS for pain, the Berg Balance Scale (BBS) for balance, and the Dynamic Gait Index (DGI) for motor function. Assessments will be conducted at baseline, post-intervention, and two weeks post-treatment. Data will be analyzed using SPSS version 26 to determine within-group and between-group differences.
This study aims to inform clinicians about effective exercise strategies for improving physical function in patients with DPN and potentially establish evidence-based rehabilitation protocols.
详细描述
Diabetic Peripheral Neuropathy (DPN) is a chronic complication of diabetes characterized by pain, numbness, and impaired balance. It frequently leads to limitations in mobility and increased fall risk, significantly affecting patients' independence and quality of life. Standard treatments often include pharmacological agents, but their long-term use is associated with adverse effects. As a result, non-drug interventions like exercise are increasingly being promoted as safer and equally effective alternatives.
Tai Chi and Modified-Otago exercise programs have individually shown promise in populations with mobility impairments. Tai Chi integrates slow, controlled movements with breathing and mindfulness, making it suitable for elderly individuals or those with chronic conditions. The Modified-Otago program was specifically designed to prevent falls through strength and balance training. While both interventions are beneficial independently, no study has yet compared their relative efficacy in managing symptoms of DPN.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders are aged 40-80 years
- •Patient having Types ii diabetes with Minimum of 5 years since diabetes diagnosis
- •Patients experiencing chronic pain for at least 6 months and level ≥ 3 on NPRS.
- •Patient having ≥ 6 score on Toronto Clinical Neuropathy Scoring System for diabetic neuropathy
排除标准
- •Non-ambulatory patients
- •Patients with ulceration/infection of feet, medical/surgical conditions
- •Patients suffering from stroke, parkinson's disease, or multiple sclerosis
研究组 & 干预措施
Tai Chi
Participants in this group will receive Tai Chi-based therapeutic exercise sessions, including joint mobility, balance, flexibility, and strength training movements (e.g., Qigong and bow stance).
干预措施: Tai Chi (Other)
Modified-Otago Exercises
Participants in this group will receive the Modified-Otago Exercise Program focused on strength and balance training through functional exercises like stair walking, knee bends, and toe raises.
干预措施: Modified-Otago Exercises (Other)
结局指标
主要结局
Pain Intensity
时间窗: 4 weeks
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), which rates pain on a scale from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Balance(4 weeks)
- Gait Performance(4 weeks)