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临床试验/NCT02798900
NCT02798900撤回不适用

The Effect of a Functional Task-training Program Combined With Therapeutic Ultrasound on Pain, Strength, Gait Biomechanics and Functionality in Adults With Hip Osteoarthritis

Universidad del Rosario1 个研究点 分布在 1 个国家开始时间: 2017年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Six minute walk test (To measure the physical function in terms of the basic mobility)

研究概览

简要总结

The aim of this study is to evaluate the effect of a functional task-training program combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality in adults with hip osteoarthritis.

详细描述

Design

The investigators propose a randomized double blind controlled clinical trial. It would include two comparison groups each with 25 participants with medical diagnosis of hip osteoarthritis classified severity II and III and inclusion criteria of the American College of Rheumatology for the classification and reporting of osteoarthritis of the hip.

All qualified participants will attend a pre-training (baseline) data collection session. During the data collection session, each participant will complete the Western Ontario and MacMaster Osteoarthritis Index (WOMAC). All participants will perform visual analog scale and six minutes walk test for assessing pain and functionality, respectively. They will be assessed their hip muscle strength using manual muscle dynamometer. Their biomechanics gait will be assessed through using an infrared motion capture system, force platforms and motion analysis software (120 Hz, BTS Smart DX100, Italy). All participants in both groups will be asked not to alter their regular physical activity or pain medications during the 15-sessions training program.

Each participant will be assessed pain, strength, gait biomechanics and functionality before and after 16 sessions of intervention. Pain and functionality will be further evaluated in sessions 5th and 10th. The first group will receive 16 sessions of a functional task training program and therapeutic ultrasound versus the second group who will only receive 16 sessions of the same functional task-training program.

Functional task-training program includes warm up, followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching. Therapeutic ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes. Temporal average intensity area corresponds to 0.44 W/cm2, the treatment area will be equal to 2 times the effective radiating area on the anterior, medial and lateral hip area.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of hip osteoarthritis

排除标准

  • Musculoskeletal disability in other lower extremity joints or trunk
  • Acute injuries of lower extremity and trunk in past three months
  • Arthroscopic surgery
  • An intra-articular injection in past three months
  • Candidate for surgery
  • Patients with fibromyalgia
  • Patients with neurologic disease
  • Participation in a structured physical activity program in past three months

结局指标

主要结局

Six minute walk test (To measure the physical function in terms of the basic mobility)

时间窗: within the first 2 weeks before the intervention

Visual Analog Scale for pain

时间窗: within the first 2 weeks before the intervention

To measure the pain intensity

Change from Baseline Visual Analog Scale for pain at 16th session of intervention

时间窗: within the first 2 weeks after the intervention

Gait biomechanics

时间窗: within the first 2 weeks before the intervention

Assess the speed, hip range of motion, and peak hip flexion/extension in the gait phases by using motion analysis system BTS SmartDX100 Brand.

Change from Baseline Gait biomechanics at 16th session of intervention

时间窗: within the first 2 weeks after the intervention

Change from Baseline Six minute walk test at 16th session of intervention

时间窗: within the first 2 weeks after the intervention

Muscle strength

时间窗: within the first 2 weeks before the intervention

It is the muscle strength of gluteus maximus, medium, quadriceps and hamstrings measured using a manual muscle dynamometer.

Change from Baseline Muscle strength at 16th session of intervention

时间窗: within the first 2 weeks after the intervention

Change of the muscle strength of gluteus maximus, medium, quadriceps and hamstrings after the intervention.

次要结局

  • Change from Baseline Six minute walk test at 5th session of intervention(After finishing the 5th session of intervention)
  • Change from Baseline Visual Analog Scale for pain at 5th session of intervention(After finishing the 5th session of intervention)
  • Change from Baseline Visual Analog Scale for pain at 10th session of intervention(After finishing the 10th session of intervention)
  • Change from Baseline Six minute walk test at 10th session of intervention(After finishing the 10th session of intervention)

研究者

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

ROSY PAOLA CARDENAS SANDOVAL

Assistant Professor

Universidad del Rosario

研究点 (1)

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