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临床试验/NCT04264429
NCT04264429Unknown不适用

Effect of the Infrapatellar Strap and Elastic Band on the Pain, Agility, Balance and Lower Limb Function Athletes With Patellofemoral Pain Syndrome

Universidade Estadual de Londrina2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年3月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
2
主要终点
Agility - Side Hope test (SHT)

研究概览

简要总结

Patellofemoral Pain Syndrome (PPS) is common in athletes, especially when performing jumps. To reduce pain and improve functionality, orthoses such as the infrapatellar strip (IPS) and functional bandage (FB) are indicated, but their effects are controversial. The objective is to evaluate the effect of IPS and FB on lower limb pain, agility, balance and strength in athletes with PPS. Will be evaluated 25 athletes with PPS (10 women and 15 men), who will answer the sample characterization questionnaires, pain scale and performed the Side Hope Test (SHT), modified star excursion balance test (SEBTm) and Sit to Stand 30 in seconds (STS30 ") to analyze lower limb agility, balance and strength, respectively. Three repetitions of each functional test will be performed, with an interval of one minute between repetitions and tests. Still, the tests will be developed with IPS, with FB and without any orthosis, with previously randomized sequence. Expected to establish the effects of IPS and FB for athletes with PPS.

详细描述

The research was approved by the ethics committee of the institution. The sample size was calculated in 18 athletes, but when considering losses 25 athletes (10 women and 15 men) were recruited.

Athletes will be over 18 years old, from different sports or teams, with a minimum of six hours / week of training / competition, with complaints of anterior knee pain (DAJ) greater than 3 on the visual analog scale (VAS), rating lower than or equal to 82 (tendency to patellofemoral disorder) in the Anterior Knee Pain Scale (AKPS) and score lower than or equal to 83 (fair or poor) on the Lysholm questionnaire. Exclusion criteria will be the history of other lower limb injuries or surgery; diabetes or altered sensitivity in the plantar region; medication and physical therapy use in the last three months.

For data collection athletes will answer the sample characterization questionnaires, AKPS and Lysholm.

Modified star excursion balance test (SEBTm), Side Hope test (SHT) and 30 second sit-up test (SL30 '') will be applied, at random and with prior familiarization, for the analysis of dynamic balance, agility and lower limb strength, respectively.

It will also be randomized the tests with Infrapatellar Strap, Elastic Bandage and without orthosis (control), developed in three different days with 96 hours interval. To apply the infrapatellar strap and elastic bandage, the athlete was positioned standing with slight knee flexion, with heel support on a pre-established surface (relaxed patellar tendon). The Infrapatellar Strap and Elastic Bandage will be positioned over the patellar tendon, with moderate pressure, on the lower limb complaining of pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Athletes will be over 18 years old,
  • From different sports or teams,
  • With a minimum of six hours / week of training / competition,
  • With complaints of anterior knee pain (DAJ) greater than 3 on the visual analog scale (VAS)
  • Rating lower than or equal to 82 (tendency to patellofemoral disorder) in the Anterior Knee Pain Scale (AKPS)
  • Score lower than or equal to 83 (fair or poor) on the Lysholm questionnaire.

排除标准

  • History of other lower limb injuries or surgery,
  • Diabetes,
  • Altered sensitivity in the plantar region,
  • Medication to pain,
  • Physical therapy use in the last three months.

结局指标

主要结局

Agility - Side Hope test (SHT)

时间窗: Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.

For the SHT analysis will be consideres the time requered for the athlete to perform 10 lateral jumps was considered.

Endurance - 30 second sit to stand test (STS30 '')

时间窗: Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.

For the 30" Sit and Lift Test it will be considered for analysis only complete cycles with full knee extension and seat weight unloading.

Change in pain intensity

时间窗: Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.

The pain will be evaluated before and after the functional tests with infrapatellar strap and elastic band, through the analogue visual pain scale (with pain characterization from zero to ten).

Balance - Modified star excursion balance test (SEBTm)

时间窗: Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.

For the analysis of SEBTm the normalization of the directions will be develop througt the length ot the lower limb of each participant (maximum distance reached in 3 directions (anteior, postero-lateral and postero-medial) / (limb length x 3) x 100 = percentage of the three directions. Distance traveled in centimeters (on a measuring tape) in the anterior, postero-medial and postero-lateral directions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christiane Macedo

Principal investigator and Professor.

Universidade Estadual de Londrina

研究点 (2)

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