Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Momna Asghar
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Berg Balance Scale (assessing change in ability to balance at baseline, 4th week and at 6th week.
研究概览
简要总结
Objective of the study is to find out the effects of Proprioceptive training in addition to routine physical therapy on balance and quality of life in patients with Diabetic neuropathy.
Alternate Hypothesis:
There will be significant difference in effects of Proprioceptive training in addition to routine physical therapy on balance and Quality of life in patients with Diabetic neuropathy.
详细描述
It was a parallel designed single blinded randomized controlled trial conducted in the Green Poly Clinic Bahria town, Lahore, Pakistan using non probability convenient sampling. patients who met eligibility criteria was informed about the aim of study. consent form were signed by all participants.After baseline assessment ,participants were randomly assigned in two groups.(ratio 1:1) The calcualted sample size was 27 in each group. i.e. 54 ( 27 in each group). After adding 20% drop out the final size will become, 64( 32 in each group) using 95% level of significance and 80% power of study.
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
single blinded
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pre-diagnosed DM for seven years.
- •Male and female patients with type 2 diabetes.
- •Patients with ≥2 DPN symptoms.
- •Patients scored>2/13 on MNSI questionnaire.
排除标准
- •Participants with Foot ulcers, Orthopedic or surgical problem in a lower limb, other neurological impairment and Major vascular complication,
- •Severe vestibular dysfunction
- •Participants with Severe retinopathy and Severe nephropathy,
- •Inability to walk independently with or without an assistive device,
- •Receiving any structured supervised physiotherapy intervention.
结局指标
主要结局
Berg Balance Scale (assessing change in ability to balance at baseline, 4th week and at 6th week.
时间窗: It was checked before the intervention started (after recruitment of patient) and then checked at the 4th week and then at the end of 6th weeks.
It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4.0 denotes inability to complete the item, and 4 the ability to accomplish the task independently (total score range, 0-56; higher = better performance). Scores of less than 45 out of 56 are accepted as indicative of balance disorders in the elderly.
WHO Quality of Life Scale (WHOQOL BREF)( assessing change in quality of life at baseline, 4th and 6th week of intervention.
时间窗: It was checked before the intervention started (after recruitment of patient) and then checked at the 4th week and then at the end of 6th weeks.
The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centers, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.It contains a total of 26 questions. To provide a broad and comprehensive assessment, one item from each of 24 facets contained in the WHOQOL-100 has been included.
次要结局
未报告次要终点