The Effect of Different Foot Orthoses (Hallux Valgus Shoe; Forefoot Relief Shoe) on the Brake Response Time After Hallux Valgus and/or Additional Forefoot Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Brake response time after hallux valgus surgery with the investigated foot orthoses
研究概览
简要总结
Patients often seek advice from their treating doctor if they are able to drive with a foot orthosis after a first metatarsal osteotomy for symptomatic hallux valgus and/or after an additional forefoot surgery. This challenging question is of obvious importance for the patient and other road users. Previous studies already issued driving ability after different orthopedic procedures and with knee and ankle devices on the brake reaction time but missed to address the same for foot orthoses after hallux valgus or forefoot surgery.
This missing evidence made us evaluate the influence of wearing a foot orthosis after a first metatarsal osteotomy or forefoot surgery on driving ability (brake response time; BRT).
The overall time frame is about nine weeks; each appointment for BRT measurement takes about fifteen to twenty minutes. The first BRT measurement is one day before the foot surgery without a foot orthosis (normal shoe)and with the orthoses (control run) (1) at two days (2), two weeks (3), four weeks (4) and six weeks (5) after the operation with a HVS and a FRS and eight weeks postoperative without a foot orthoses (6).
详细描述
The purpose of this study is to asses driving ability (brake response time) and the influence of two types of different foot orthoses after foot surgery.
Therefore we have two groups:
- Hallux valgus surgery (Chevron, Austin, SCARF, Akin etc.)
- Hallux valgus and additional forefoot surgery (Chevron, Austin, SCARF, Akin etc. and WEIL - Osteotomy, Peg-in-Hole, etc.)
BRT (brake response time) is assessed with commonly used right-sided hallux valgus shoes (HVS) and forefoot relief shoes (FRS). We measure the BRT at six different time points: one day before surgery without a foot orthosis (normal shoe)and with the orthoses (control run) (1) at two days (2), two weeks (3), four weeks (4) and six weeks (5) after the operation with a HVS and a FRS and eight weeks postoperative without a foot orthoses (6). The overall time frame is about nine weeks; each appointment for BRT measurement takes about fifteen to twenty minutes.
The BRT was assessed using a custom-made driving simulator as used in previously published studies. Participants were instructed to apply the brake pedal exclusively with the right foot as quickly as possible on a visual stimulus. The time interval until the subject operated the brake was measured 20 times, averaged and then taken as BRT value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants must have a valid driver´s license,
- •used the right foot exclusively for accelerating and braking,
- •free of any medical condition that could impair the ability to drive
排除标准
- •taking medications that could affect reaction time (e.g. benzodiazepines and over-the-counter allergy and cold medications)
- •had a history of alcohol or drug abuse,
- •a central nervous system disorder such as epilepsy,
- •a metabolic disorder,
- •a psychiatric disorder,
- •musculoskeletal disease,
- •any visual acuity disorder (macular degeneration etc.; glasses allowed)
研究组 & 干预措施
Hallux valgus Surgery
Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy, Chevron, SCARF, Austin, etc.)
干预措施: Hallux valgus Shoe (Device)
Hallux valgus Surgery
Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy, Chevron, SCARF, Austin, etc.)
干预措施: Forefoot relief shoe (Device)
Hallux valgus and forefoot surgery
Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy; Chevron, Austin, SCARF, etc.) and additional forefoot surgery (PIP arthrodesis, second/third/etc. metatarsal osteotomy, etc.; Peg-in-Hole, WEIL-Osteotomy, etc.)
干预措施: Hallux valgus Shoe (Device)
Hallux valgus and forefoot surgery
Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy; Chevron, Austin, SCARF, etc.) and additional forefoot surgery (PIP arthrodesis, second/third/etc. metatarsal osteotomy, etc.; Peg-in-Hole, WEIL-Osteotomy, etc.)
干预措施: Forefoot relief shoe (Device)
Control Run
Measurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses
干预措施: Forefoot relief shoe (Device)
Control Run
Measurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses
干预措施: Hallux valgus Shoe (Device)
Control Run
Measurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses
干预措施: Retail Shoe (Device)
结局指标
主要结局
Brake response time after hallux valgus surgery with the investigated foot orthoses
时间窗: July 2015 (The overall time frame is about nine weeks)
次要结局
未报告次要终点
研究者
Dammerer Dietmar, MD
Dr. med. univ. Dietmar Dammerer
Medical University Innsbruck