The Development and Clinical Verification of Intelligent Rehabilitation System for Leg Length Discrepancy Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Visual analogue scale, VAS
研究概览
简要总结
A structural leg length discrepancy (SLLD) is a common clinical problem. Its prevalence has been estimated at 40-70%. Those who have been suffered from limping for a long time may lead to follow-up low back pain and lower limb musculoskeletal disorders. Although lower limb triple view of x-ray is considered to be the current technique for determining LLD, it is costly and time consuming that not every hospital can afford it, and in case of radiograph, the patient is exposed to radiation. Therefore, it is necessary to develop a rapid clinical assessment method by gathering exterior parameters to build up a Regression model for measuring the discrepancy and determining LLD accurately.
While using shoe lifts to correct discrepancy is the easiest conservative intervention for LLD, there are still many controversies on how much height should be added clinically and academically. The optimal height should be added depends on feedbacks from users and gait performance. The best gait performance can be measured from kinematic performance of center mass of body during walking. Therefore, this project wants to compare treatment responses between two kinds of shoe lift height correction methods for LLD: given 80% discrepancy in shoe lift height correction through triple view of x-ray and given optimal shoe lift height correction through analyzing kinematic performance of center mass of body.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 20 to 70
- •being able to walk independently
- •being diagnosed with congenital SLLD or not
- •willing to cooperate to wear shoe lifts
- •has smart phone and willing to record information that investigators need
- •willing to sign agreement
排除标准
- •neurological diseases (i.e. Parkinson's disease, CVA, Polio, and lower limb nerve injuries, etc.)
- •diabetes along with peripheral neuropathy
- •history of lower limb fracture injury or joint replacement leading to uneven leg length
- •osteoporosis along with compression fracture
- •foot, ankle, or knee joint deformity, osteoarthritis or soft tissue pain that disturb gait performance (ex. degenerative osteoarthritis, plantar fasciitis, and etc.)
- •pregnancy
- •idiopathic scoliosis
- •history of psychological disease or drug addiction
结局指标
主要结局
Visual analogue scale, VAS
时间窗: Changes from baseline in VAS for six month continually
Pain fields of every participant in two groups will be recorded by APP every day for six month continually. The pain fields include：bilateral cervical, trunk, upper limb, lower limb, and foot regions, totally 10 regions. The score of each region is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The total score may range from 0-1000.
次要结局
- Degree of comfort(Changes from baseline in comfort scale for six month continually)
- muscle activity(Changes from baseline in muscle activity after intervention immediately and at 4, 8, 12, 24 weeks)
- contact area (cm^2)(Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks)
- plantar force (kgw)(Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks)
- spatio-temporal parameters of gait(Changes from baseline in spatio-temporal parameters of gait after intervention immediately and at 4, 8, 12, 24 weeks)
- plantar pressure (kgw/cm^2)(Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks)
- areas of pain (cm^2)(Changes from baseline in areas of pain one time per week for six month)
- three dimensional changing joint angles and trunk sway during walking(Changes from baseline in three dimensional joint angles between two segments and trunk sway during walking after intervention immediately and at 4, 8, 12, 24 week)
- Energy expenditure (Joule)(Changes from baseline in plantar force and pressure after intervention immediately and at 4, 8, 12, 24 weeks)