Comparative Effects of Balance and Resisted Training on Pain and Balance In Patients With Diabetic Peripheral Neuropathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- PainDETECT Tool
研究概览
简要总结
The aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy.
详细描述
This randomized clinical trial will be conducted at Mumtaz Bakhtawar Hospital in 7 months after the approval of synopsis. The sample size for this trial will be 58 patients with DPN. Participants those meet inclusion criteria will be randomly allocated into two groups using online randomization tool, 29 participants will be assigned to Group A which will receive Balance training exercises for 35 minutes and Group B will receive Resistance Training exercises for 45 minutes. Each participant will receive intervention for 3 alternate days per week for 8 weeks.
The Michigan neuropathy screening instrument will be used for the assessment of DPN symptoms scores at baseline. Balance will be evaluated using the De Morton mobility index (DEMMI) test, while painDIRECT tool will be utilized to measure pain. The data will be entered and analyzed using SPSS version 24 for windows software.
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)
盲法说明
The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with DNP with score ≥ 2.5 on Michigan neuropathy screening instrument of both genders.
- •Age between 40 to 65 years.
- •Patients having the minimum history of diabetes is 7 years.
- •History of mild to moderate neuropathy . The patients ability to do resistance and aerobic exercises.
排除标准
- •History of taking anti-inflammatory drugs.
- •History of recent surgical operations of joints in lower extremities.
- •Patients suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy.
- •Patients having any disability, fracture, or dislocation of at least six months before the study.
研究组 & 干预措施
GROUP A (BALANCE EXERCISES)
Group A will receive a session of balance exercises for 45 minutes.Treatment session will be given for 3 days per week for 8 weeks.This balance exercise program consist of three phases.Warm-up phase(5 minutes,after warm-up phase 35 minutes balance exercises then cooling phase (5 minutes).
干预措施: Balance exercises (Other)
GROUP B (RESISTED EXERCISES)
Group B will receive a session of resisted exercises for 45 minutes.Treatment session will be given for 3 days per week for 8 weeks.This resisted exercises program consist of three phases.Warm-up phase(5 minutes,after warm-up phase 35 minutes balance exercises then cooling phase (5 minutes).
干预措施: Resisted exercises (Other)
结局指标
主要结局
PainDETECT Tool
时间窗: 8th week
painDETECT scale to detect diabetic neuropathic pain which includes symptom questioning and also the type, severity and the radiation of pain.
Michigan neuropathy screening instrument
时间窗: 8th week
This screening tool consists of two sections: Section A, self-administered by the patient, involves 15 yes/no questions about clinical symptoms, and Section B is based on a clinical evaluation. Positive and negative sensory symptoms, cramps, muscle weakness, foot ulcers, cracks, and amputation are assessed.
De Morton mobility index test
时间窗: 8th week
It consists of 15 items covering a broad spectrum of mobility levels and it has shown satisfactory Clinometric properties (30). In this method, the static balance is measured on one leg and two legs, as well as at the closing of the eyes; on the other hand, the dynamic balance is measured and evaluated when the patient jumps and moves four steps back.
次要结局
未报告次要终点