跳至主要内容
临床试验/NCT02386631
NCT02386631已完成不适用

Hallux Valgus and the Effects of Custom Orthotic Prescription on the Efficacy of Forward Propulsion

Dr. Stephen Perry2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Increased Propulsive moments (torques) as measured by inverse dynamics

研究概览

简要总结

Hallux valgus can be defined as a progressive subluxation of the first metatarsophalangeal joint and lateral deviation of the hallux. This common foot condition is associated with altered gait patterns. Specifically reduced forward propulsion, leading to gait instability. Research has shown that foot problems and pain play a major role towards the contribution of falls in the adult population. There are currently two main interventions for the treatment of hallux valgus: surgery and orthotic prescription. There has not been a lot of research performed evaluating the effects of custom orthotic prescription on hallux valgus.

Therefore, this study will investigate adults with moderate hallux valgus and the effects of orthotic intervention on the efficacy of forward propulsion during walking. It is hypothesized that implementation of an orthotic will lead to decreased foot pain, an increase in step length, an increase in the forward moment about the ankle and hallux, and a more medial center of pressure tracking through the great toe instead of the lesser metatarsals.

This study will consist of 10 adults. The participant will go through three rounds of testing in the lab. The first session will consist of initial baseline testing in which each participant will be evaluated for severity of Hallux Valgus and range of motion of the first metatarsophalangeal joint. A foot casting will then be performed by a pedorthist and the participant will be set up with markers, so as to record motion while they perform 15 walking trials across a 10m runway with a force plate embedded in the middle whilst wearing standard footwear (no orthotic). The second lab session will consist of the standard footwear (no orthotic) walking as well as the addition of standard footwear with custom orthotic walking. The third session, after having worn the orthotic for two weeks, will repeat both conditions measured in the second lab session. Data about the center of pressure trajectories, step length, foot pain, and the moments about the ankle and first metatarsophalangeal joints will be collected and calculated.

详细描述

The participants will enter the lab three times. On their first session, the level of severity of hallux valgus of the participant will be identified. The participant will sit in a chair, with their bare feet resting on the ground. A picture of their foot will be taken in the transverse plane. Another picture will then be taken of the foot when the individual is in a standing position. The participant will not experience any pain or discomfort during this test as only 2 pictures will be taken of the foot.

The participant will then have range of motion testing performed on their first metatarsophalangeal joint. This will be performed by the researcher passively dorsiflexing the first metatarsophalangeal joint and measuring the angle created with a goniometer.

The participant will also have an orthotic foot casting performed by a pedorthist. This foot casting will be performed to create a mould of the foot that will be used by a pedorthist to construct the orthotic.

After the participant put on the standard footwear (no orthotic) they will be set up with optotrak markers with three on the first ray, three on the midfoot, three on the heel, and three on the medial distal tibia. Then the participant will walk across a 10m walkway with a force plate embedded half way along the walkway at a constant velocity for a total of 15 trials. The participant will rate their pain on the visual analogue scale (VAS) immediately following the completion of the 15 walking trials.

On the second session, the participant will once again be set up with optotrak marker and will perform 15 walking trials with the standard footwear (no orthotics) and rate their pain level on the VAS. The custom orthotic will be placed in the standard footwear. Then the participant will perform 15 walking trials and rate their pain on the VAS. The participant will then be instructed to wear the orthotic for seven hours a day, seven days a week for two weeks. During this two week period, the principal investigator will call the participant once, after about 1 week, to ask about how the orthotic wear is going. In specific, how often they have been wearing it and for how long.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • moderate Hallux Valgus, as classified using the Manchester Scale
  • good range of motion of the first metatarsophalangeal joint
  • able to walk

排除标准

  • no history or clinical evidence of any chronic disease and no history of lower extremity surgery
  • medication that affect balance and stability

结局指标

主要结局

Increased Propulsive moments (torques) as measured by inverse dynamics

时间窗: measured at each visit (baseline, 1 week, 2 weeks), orthotic vs. no orthotic

calculation of moments (torques) produced at the ankle and first metatarsophalangeal joint during push-off phase of the gait cycle

次要结局

  • Increased Gait Velocity(measured at each visit (baseline, 1 week, 2 weeks), orthotic vs. no orthotic)

研究者

发起方
Dr. Stephen Perry
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Stephen Perry

Professor

Wilfrid Laurier University

研究点 (2)

Loading locations...

相似试验

Hallux Valgus and Custom Orthotic Prescription | 临床试验