Effect of Sensorimotor Training on Gait, Ankle Muscle Strength 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
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Measurement of stride length
研究概览
简要总结
Diabetic peripheral neuropathy is a common chronic complication of diabetes mellitus which results in high public health costs and has a huge impact on patients' quality of life. It leads to sensory and motor deficits, which often result in mobility-related dysfunction, and alterations in gait characteristics. These alternations in gait performance cause increase in the risk of fall, which has the strongest association with symptoms of depression in patients with diabetes. However, little is known about possible treatment strategies for improving gait ability and reduce risk of fall in patients with diabetic neuropathy. So, the purpose of this study will be to investigate the effect of sensorimotor training on ankle muscle strength, gait and quality of life in patients with diabetic peripheral neuropathy.
To determine if there is an effect for sensorimotor training on gait, ankle muscle strength and quality of life in patients with diabetic peripheral neuropathy, the patient will be assessed before and after 6 weeks of treatment by measurement of ankle muscles strength using isokinetic dynamometer, measurement of different spatiotemporal gait parameters using gait trainer instrument , and assessment of quality of life of the patients using HRQL questionnaire (SF-36) before and after the treatment sessions.
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who have body mass index did not exceed 30 Kg/m
- •type II diabetes mellitus diagnosed for at least 7 years.
- •able to walk without assistance or assistive device
- •able to stand on both feet and on one leg
- •have controlled blood glucose level by the screening by Glycated Haemoglobin test (9 % > HbA1c > 6.5 %) .
排除标准
- •The patients will be excluded if they have:
- •cognitive deficits, severe retinopathy, scares under their feet, hypo or hypertension, any medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, other neurological or orthopaedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, or severe osteoarthritis), and severe nephropathy that causes edema or needs haemodialysis.
结局指标
主要结局
Measurement of stride length
时间窗: change from baseline at six weeks
Stride length is one of distance variables for measurement of kinematic gait analysis. It is the linear distance from the posterior aspect of the heel of one foot to the posterior aspect of the heel of the same foot and measured by (meter) It will be measured using the Biodex Gait Trainer
Measurement of step length
时间窗: change from baseline at six weeks
Step length is one of distance variables for measurement of kinematic gait analysis. It is the linear distance from the posterior aspect of the heel of one foot to the posterior aspect of the heel of the opposite foot and measured by (meter) It will be measured using the Biodex Gait Trainer
Measurement of walking speed
时间窗: change from baseline at six weeks
Speed of walking is one of time variables for measurement of kinematic gait analysis. It measured by (meter/second). It will be measured using the Biodex Gait Trainer: It is a device designed specifically for assessment, rehabilitation and retraining of gait for all patients, which composed of a treadmill with an instrumented deck that monitors and records kinematic gait parameters with a high resolution color touch screen (Liquid-Crystal Display) attached to the treadmill to control the device settings and display results.
次要结局
- Proprioception of ankle joint(change from baseline at six weeks)
- Assessment of Quality of life(change from baseline at six weeks)
- Muscle strength of ankle dorsiflexors and plantar flexors(change from baseline at six weeks)
研究者
Marwa Shafiek Mustafa Saleh
assistance professor doctor
Cairo University