Influence of Physical Therapy Intervention on the Foot and Ankle in Gait Biomechanics in Individuals With Diabetic Neuropathy: a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Peak pressure at lateral forefoot
研究概览
简要总结
The hypothesis is that a physical therapy intervention for foot and ankle of diabetic neuropathic individuals would affect positively the way they walk, lowering the harmful forces that these segments receive, that are associated mainly with lower range of movement, muscle weakness and loss of sensation. The participants will be randomly assigned into control group (regular treatment prescribed by their medical group) or into treatment group, that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes each session. This will aim for increasing foot and ankle range of movement, muscle strength and improving sensory inputs.
详细描述
In this study, were included subjects diagnosed with diabetic neuropathy, aged between 45 and 65 years old. We aimed to assess the effect of a physical therapy program on biomechanics of lower limbs during gait.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes mellitus type 1 or 2 diagnosed for at least seven years
- •body mass index ranging 18.5-29.9 kg/m2 (normal and overweight classifications)
- •diabetic polyneuropathy diagnosed by the medical care center: score higher than 2 out of 13 in the Michigan Neuropathy Screening Instrument (MNSI) questionnaire, indicating the presence of at least two diabetic polyneuropathy symptoms; score higher than 1 out of 10 for physical assessment of the MNSI instrument, but always including impaired vibration perception
- •ability to walk independently in the laboratory
排除标准
- •ulceration not healed for at least 6 months
- •partial or total foot amputation
- •receiving any physiotherapy intervention or offloading devices
- •neurological or orthopedic impairments
- •major vascular complications
- •severe retinopathy
- •severe nephropathy
结局指标
主要结局
Peak pressure at lateral forefoot
时间窗: 12 weeks
次要结局
- Peak pressure(24 weeks)
- Sagittal peak of extensor moment of ankle(24 weeks)
- Sagittal peak of flexor moment of ankle(24 weeks)
- Michigan Neuropathy Screening Instrument score for symptoms(24 weeks)
- Michigan Neuropathy Screening Instrument score for physical assessment(24 weeks)
- Time-to-peak pressure(24 weeks)
- Pressure-time integral(24 weeks)
- Mean velocity of center of pressure displacement(12 weeks)
- Mean velocity of center or pressure displacement(24 weeks)
- Sagittal range of motion of ankle(24 weeks)
- Functional tests score(24 weeks)
- Muscle function score(24 weeks)
- Activities-Specific Balance Confidence Scale (ABC)(24 weeks)