Clinical Trial: The Effect of Functional Task Training Combined With Therapeutic Ultrasound on Adults With Hip Osteoarthritis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 ultrasoun
Sponsor: Universidad del Rosario

Current Primary Outcome:

  • Visual Analog Scale for pain [ Time Frame: 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 [ Time Frame: within the first 2 weeks after the intervention ]
  • Muscle strength [ Time Frame: 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 [ Time Frame: within the first 2 weeks after the intervention ]
    Change of the muscle strength of gluteus maximus, medium, quadriceps and hamstrings after the intervention.
  • Gait biomechanics [ Time Frame: 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 [ Time Frame: within the first 2 weeks after the intervention ]
  • Six minute walk test (To measure the physical function in terms of the basic mobility) [ Time Frame: within the first 2 weeks before the intervention ]
  • Change from Baseline Six minute walk test at 16th session of intervention [ Time Frame: within the first

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change from Baseline Visual Analog Scale for pain at 5th session of intervention [ Time Frame: After finishing the 5th session of intervention ]
    • Change from Baseline Visual Analog Scale for pain at 10th session of intervention [ Time Frame: After finishing the 10th session of intervention ]
    • Change from Baseline Six minute walk test at 5th session of intervention [ Time Frame: After finishing the 5th session of intervention ]
    • Change from Baseline Six minute walk test at 10th session of intervention [ Time Frame: After finishing the 10th session of intervention ]


    Original Secondary Outcome:

    • Change from Baseline Visual Analog Scale for pain at 5th session of intervention [ Time Frame: 3rd week of intervention ]
    • Change from Baseline Visual Analog Scale for pain at 10th session of intervention [ Time Frame: 5th week of intervention ]
    • Change from Baseline Six minute walk test at 5th session of intervention [ Time Frame: 3rd week of intervention ]
    • Change from Baseline Six minute walk test at 10th session of intervention [ Time Frame: 5th week of intervention ]


    Information By: Universidad del Rosario

    Dates:
    Date Received: May 23, 2016
    Date Started: January 2017
    Date Completion: December 2018
    Last Updated: July 8, 2016
    Last Verified: July 2016