The Effects of 12-week Custom-made Orthotic Intervention on the Structure and Function of the Foot of Healthy Young Adults During Gait Termination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Cross-sectional area (CSA) of intrinsic foot muscles
研究概览
简要总结
The purpose of this study is to explore the long-term effects that orthotics imposes on the structure and function of the foot. The objectives of the study are to determine if the use of custom-made foot orthotics (CFO) cause: (a) changes to the structure of the plantar intrinsic muscles, (b) changes in the rate of muscle activity and timing in the plantar intrinsic muscles and (c) creates any changes in balance control during gait termination. The aim of the study is to enhance the appropriate dispensing of orthotics, and whether additional measures, such as rehabilitation exercises are necessary to increase their overall effectiveness in the clinical setting.
详细描述
Between 20-30 healthy young adults of both males and females will be recruited. A screening questionnaire will be administered to ensure that participants are appropriate for the study.
Once the participant has met the criteria of the study, the participants will be randomly allocated into one of two groups: (a) the control group or (b) the intervention group. Individuals that are selected to be in the intervention group, will be fitted with custom-made orthotics by an experienced pedorthist. The pedorthist will cast the foot posture using a foam impression to custom the design of the foot orthotic. The participant will have a week to acclimatize to the new environment, and if any discomfort arises the pedorthist will make any necessary corrections and the participant will have another week to acclimatize to the orthotic. The control group will not receive an intervention and ask to go about their daily life activities. All participants will undergo the same testing procedures at 6 and 12 weeks after baseline testing.
At baseline, 6 weeks and 12 weeks post-baseline, the researcher will take a diagnostic ultrasound image of the foot muscles prior to the gait trials. The researcher will also place 12 infrared markers and surface electrodes on the participant. All trials will be performed barefoot. The participants will then undergo a gait termination protocol. Participants will walk down an 8m walk-way with three force plates are embedded into the ground. Participants will be asked to walk to the end of the platform until instructed to stop. For 20% of the gait trials, the participants are walking forward until they hear an audio buzzer sound that will signal them to terminate their gait suddenly in the next two steps. All trials will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a score of (+5) on the Foot Posture Index (FPI)
- •navicular height < 3.6cm
- •able to walk
排除标准
- •have worn CFOs in the past year,
- •current lower limb injury, leg or foot pain
- •neurological or musculoskeletal disorders affecting the function of the foot
- •previous history of lower limb surgery
- •protein intake above the recommended daily allowance (RDA)
- •medications that effect balance.
研究组 & 干预措施
Control
Wearing own footwear
Orthotics
Custom made orthotic provided for study
干预措施: Custom-made Foot Orthotics (CFO) (Device)
结局指标
主要结局
Change in Cross-sectional area (CSA) of intrinsic foot muscles
时间窗: Baseline, 6 weeks, and 12 weeks post baseline
the area of the cross section of a muscle perpendicular to its fibers
change in muscle activity and timing of Electromyography (EMG)
时间窗: Baseline, 6 weeks, and 12 weeks
muscle activity and muscle timing
change in Balance stability margin
时间窗: Baseline, 6 weeks, and 12 weeks
how close their body gets to perimeter of their base of support
次要结局
- Stride Length(Baseline and 12 weeks)
- Range of motion (ROM)(Baseline and 12 weeks)
- Stride Width(Baseline and 12 weeks)
- Gait Velocity(Baseline and 12 weeks)
研究者
Katrina Protopapas
Principal Investigator
Wilfrid Laurier University
