Clinical Outcomes Related to Treatment of Ankle Injury Using Semiconductor Embedded Therapeutic Socks: A Randomized, Prospective, Double Blinded Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- FAOS Score
研究概览
简要总结
The goal of this clinical trial is to determine if semiconductor fabric embedded in socks can improve healing after non operative ankle sprains. The main questions it aims to answer are:
- How does semiconductor embedded sock effect outcomes in patients undergoing rehabilitation from ankle injury?
- How does semiconductor embedded socks effect injury symptoms and function throughout the course of treatment?
Researchers will compare semiconductor embedded socks with typical compression socks to determine differences in healing.
Participants will be given the socks and be asked to wear them throughout the healing process and record symptoms and functional measures.
详细描述
STUDY SUMMARY Injuries to the foot and ankle are highly prevalent, with great susceptibility to various injury types due to high usage and complex structural makeup. Ankle injuries are responsible for over 1 million Emergency Room visits each year, and ankle sprains are seen at an incidence of up to 19.0 - 26.6 per 1000 person-years. Approximately 2 million ankle sprains occur annually in the United States alone, and the incidence of re-injury is high, between 12 - 47% of reported ankle sprains are recurrent following initial injury. Ankle sprains are the most commonly presenting sports-related injury each year. Lateral ankle sprains are the most commonly reported type of ankle sprains compared to syndesmotic and medial sprains, and females are at greater risk of sustaining an ankle sprain compared with male counterparts.
Symptoms include pain, swelling, instability and tenderness. Ankle sprains are generally considered treatable and return to activity and sport are typically expected to be successful with proper rehabilitation adherence and measures taken to reduce risk of complication.
The proposed study seeks to evaluate the effectiveness of a non-compressive, therapeutic socks throughout a 12-week course of rehabilitation for non-surgically treated ankle sprain or fracture injury. Outcome measures will be collected at standard intervals up to 1 year to evaluate effectiveness of treatment.
BACKGROUND Treatment approaches for ankle injuries are dictated by the injury type and severity, and include early immobilization, bracing and splinting, return to mobilization as tolerated, rehabilitation strengthening exercises, stabilizing shoes or devices, and pain medication.
Evidence from Lamb, et. al supports a period of up to 14 days of immobilization in a below-knee cast or Aircast instead of a tubular compression bandage and demonstrates improved quality of ankle function after 3 months.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Statistician
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ankle sprain, avulsion fracture, distal fibular fracture
- •Pain for at least 1 day
- •Patients 18-69 years old
排除标准
- •Patients with neurological conditions
- •Patients with prior surgical treatment of lower limb injury
- •Patients with chronic pain conditions
- •Patient with auto-immune or auto-inflammatory disease
- •Patients with tobacco use in last 90 days
- •Patients with history of metabolic disorders
- •Patients with open wound at area of application
- •Patients with acute or systemic infection
研究组 & 干预措施
Semiconductor Embedded Sock
干预措施: Semiconductor Embedded Sock (Device)
Control Compression Sock
干预措施: Control Compression Sock (Device)
结局指标
主要结局
FAOS Score
时间窗: 6 months
Improved patient function compared to placebo group as determined by pre-treatment and post-treatment Patient Specific Foot Function Index Foot and Ankle Outcome Score (FAOS) compared to placebo group. Range of Scores: \[0-100\], higher scores indicates a better outcome.
次要结局
未报告次要终点