Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
The objective of this study is to compare tape versus semi rigid support versus lace up brace treatment for acute lateral ankle ligament injuries with regard to clinical outcome and cost effectiveness.
There is a difference of 10 in functional outcome (Karlsson Score) between non-elastic adhesive taping and semi-rigid and lace-up ankle support, in favour of the last, for the treatment of acute lateral ankle ligament injury at 6 months follow-up.
研究概览
地位
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Apeldoorn、荷兰、7300 DS
- Gelre Hospitals
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients > 18 years
- Grade II or III ankle sprains
- Presentation < 72 hours after the acute injury
Exclusion Criteria:
- Patients with a history of chronic instability
- Who had a fracture on X-ray investigation
- Other injuries or disabilities on the same limb
- Alcoholism, serious psychiatric and neurological illness
- Patients with bilaterally sprained ankles
- Patients with previous surgery on the lateral ankle ligaments
- Skin diseases where taping is not practicable
- Patients who are unable to give informed consent
- Patients who are unable to fill out questionnaires
- Neuromuscular disorders of the lower extremities
- Active rheumatoid arthritis
- Gait disturbances
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:tape
Group I will be treated with non-elastic adhesive tape around the affected ankle, applied by the 'van Unen-technique'.
This technique is an alternative for the 'Coumans- technique'.
The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue.
Different materials can be used alone or in combination.
The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself.
Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity.
Taping is a treatment that involves no loss of time, requires no crutches and is not attended with any ultimate impairment of function.
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Group I will be treated with non-elastic adhesive tape (Leukotape® Classic) around the affected ankle, applied by the 'van Unen-technique'.18
This technique is an alternative for the 'Coumans- technique'.15
The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue.
Different materials can be used alone or in combination.
The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself.
Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity.
Group II will be treated by application of a semi-rigid brace, the M-step® from Medi®.
The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression.
The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle.
The pads are very light and have a soft fleecy surface.
Even the edges of the outer moldings are generously padded.
The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.
Group III will be treated by application of a lace-up brace, the ASO brace.
The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe.
The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel.
Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application.
The calcaneus is captured, effectively locking the heel.
The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.
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有源比较器:Lace-up brace
The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe.
The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel.
Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application.
The calcaneus is captured, effectively locking the heel.
The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.
|
Group I will be treated with non-elastic adhesive tape (Leukotape® Classic) around the affected ankle, applied by the 'van Unen-technique'.18
This technique is an alternative for the 'Coumans- technique'.15
The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue.
Different materials can be used alone or in combination.
The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself.
Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity.
Group II will be treated by application of a semi-rigid brace, the M-step® from Medi®.
The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression.
The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle.
The pads are very light and have a soft fleecy surface.
Even the edges of the outer moldings are generously padded.
The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.
Group III will be treated by application of a lace-up brace, the ASO brace.
The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe.
The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel.
Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application.
The calcaneus is captured, effectively locking the heel.
The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.
|
有源比较器:Semi rigid brace
A semi-rigid brace, the M-step® from Medi®, will be applied.
The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression.
The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle.
The pads are very light and have a soft fleecy surface.
Even the edges of the outer moldings are generously padded.
The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.
|
Group I will be treated with non-elastic adhesive tape (Leukotape® Classic) around the affected ankle, applied by the 'van Unen-technique'.18
This technique is an alternative for the 'Coumans- technique'.15
The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue.
Different materials can be used alone or in combination.
The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself.
Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity.
Group II will be treated by application of a semi-rigid brace, the M-step® from Medi®.
The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression.
The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle.
The pads are very light and have a soft fleecy surface.
Even the edges of the outer moldings are generously padded.
The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.
Group III will be treated by application of a lace-up brace, the ASO brace.
The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe.
The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel.
Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application.
The calcaneus is captured, effectively locking the heel.
The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Karlsson score
大体时间:up to 6 months FU
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The patients were asked to fill out a questionnaire regarding the function of the ankle joint.
The score includes eight items based on a subjective evaluation of stability, pain, swelling and stiffness in relation to activities of everyday life, sports and recreational activities, running, stair climbing and working ability.
The maximum score is 100 points.
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up to 6 months FU
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Return to work
大体时间:up to 6 months FU
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Time to return to work Work at level / below level / no return to work
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up to 6 months FU
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Return to sports
大体时间:up to 6 months FU
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Time to return to sports Sports at level / below level /no return to sports
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up to 6 months FU
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Pain VAS
大体时间:up to 6 months FU
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VAS score 0-10: 0 = no pain, 10 = unbearable pain
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up to 6 months FU
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Objective stability
大体时间:up to 6 months FU
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Anterior Drawer Test (ADT). The patient sits on a bench with the legs hanging downwards. The knee joint is flexed and the foot held in 150 plantar flexion. First the healthy ankle is examined. Examination is performed according to van Dijk. 38 The examiner assigned one of the four predetermined numbers to each examined ankle joint, based on the estimated anterior displacement of the talus relative to the tibia. 0 = 0-2mm, 1 = 3-5mm, 2 = 6-10mm and 3 = 11-15mm |
up to 6 months FU
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Objective stability
大体时间:up to 6 months FU
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DAAT.
Because the manual ADT is of a subjective nature we measure the instability with the dynamic anterior ankle tester (DAAT).
39 The principle of the test is to apply a force impulse tot the calcaneus, within the muscle reflex time, and to measure anterior-posterior translation and mediolateral rotation.
The highest and the lowest score were discarded and the mean of the three remaining scores counted as the result of the test.
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up to 6 months FU
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Range of motion (ROM)
大体时间:up to 6 months FU
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Degrees maximum dorsiflexion to plantarflexion
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up to 6 months FU
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Recurrent inversion injury
大体时间:up to 6 months FU
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Yes/no Number of sprains per month
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up to 6 months FU
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Complications / adverse events
大体时间:up to 6 months FU
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Any event leading to discontinuation of study participation and temporary or permanent physical damage due to the treatment under investigation (Local skin irritations (contact dermatitis and folliculitis), sensory deficit, stiffness, muscle atrophy). Use of not allowed painkillers is also an adverse event.
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up to 6 months FU
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Tegner activity level
大体时间:up to 6 months FU
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Mean per group
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up to 6 months FU
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EuroQol (EQ5D)
大体时间:up to 6 months FU
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The EuroQol (EQ5D) is a health related quality of life instrument that provides a single index of an individual's quality of life.
It consists of 5 dimensions resulting in 243 possible health states.
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up to 6 months FU
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Costeffectiveness
大体时间:up to 6 months FU
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Main objective of the economic evaluation is to assess the cost effectiveness and cost-utility of brace and tape therapy of acute lateral ankle ligament injury.
The economic evaluation will be performed from a societal perspective, implying that both direct health care and direct non-health care costs, as well as indirect costs will be used as economic indicators.
Firstly, relevant categories of resource utilisation were identified.
Secondly, the volume of each category was measured and multiplied by the resource costs.
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up to 6 months FU
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Compliance
大体时间:up to 6 months FU
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How many full days did you not wear the (semi rigid / lace-up) brace?
Tape compliance is always 100% (except in cases of complications / adverse events)
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up to 6 months FU
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FAOS
大体时间:up to 6 months FU
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FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport Rec), and foot and ankle-related Quality of Life (QOL).
The last week is taken into consideration when answering the questionnaire.
Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
The result can be plotted as an outcome profile.
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up to 6 months FU
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合作者和调查者
调查人员
- 首席研究员:Eric EJ Raven, MD、Gelre Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Tape的临床试验
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Universidad Miguel Hernandez de ElcheHospital Universitario San Juan de Alicante未知