Effects of Foot Center of Pressure Manipulation on Hip Osteoarthritis Patients During Gait

This study is not yet open for participant recruitment.
Verified October 2011 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01450254
First received: October 3, 2011
Last updated: October 10, 2011
Last verified: October 2011

October 3, 2011
October 10, 2011
November 2011
September 2015   (final data collection date for primary outcome measure)
  • Change from Baseline in Gait Patterns at 3 months, 6 months, and 12 months [ Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months ] [ Designated as safety issue: No ]

    Three-dimensional gait analysis of spatiotemporal, kinetic, and kinematic parameters.

    Center of pressure measurements.

  • Change from Baseline in Muscle Activation Patterns at 3 months, 6 months, and 12 months [ Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months ] [ Designated as safety issue: No ]
    Surface electromyographic analysis of muscle activation patterns.
Same as current
Complete list of historical versions of study NCT01450254 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Physical Function at 3 months, 6 months, and 12 months [ Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months ] [ Designated as safety issue: No ]

    Self-evaluation questionnaires.

    Physical function tests.

    Energy consumption measurements.

  • Change from Baseline in Pain at 3 months, 6 months, and 12 months [ Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months ] [ Designated as safety issue: No ]
    Self-evaluation questionnaires.
  • Change from Baseline in Quality of Life Assessments at 3 months, 6 months, and 12 months [ Time Frame: From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months ] [ Designated as safety issue: No ]
    Self-evaluation questionnaires.
Same as current
Not Provided
Not Provided
 
Effects of Foot Center of Pressure Manipulation on Hip Osteoarthritis Patients During Gait
Effects of Foot Center of Pressure Manipulation on Hip Biomechanics, Muscle Activation Patterns, and Energy Consumption During Gait in Hip Osteoarthritis Patients

The purpose of this study is to:

  1. Analyze the short-term effects of external center of pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait on:

    1. Gait parameters (spatiotemporal, kinematic, and kinetic)
    2. Muscle activation patterns of the lower limbs and back
  2. Analyze the long-term effects (during the period of one year) of external center of pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait on:

    1. Gait parameters (spatiotemporal, kinematic, and kinetic)
    2. Motor learning and muscle activation patterns
    3. Energy consumption
    4. Pain, physical function, and quality of life

The hypotheses of the study, in reference to the aforementioned study objectives are:

  1. Changes in foot center of pressure will have an immediate effect on gait parameters and muscle activation patterns of the lower limbs and back.
  2. Long-term manipulation of foot center of pressure, as a result of a year-long rehabilitation program using the AposTherapy Biomechanical System, will result in improvement in gait parameters, changes in muscle activation patterns as a result of new motor learning, improvement in energy consumption, decrease in pain, improvement in physical function, and improvement in quality of life.

This study is a randomized prospective controlled study assessing the short and long-term effects of external foot center-of-pressure manipulation on gait pattern, muscle activation pattern, energy consumption, physical function, pain, and quality of life. Sixty patients will be recruited for the study and divided randomly into two groups, an experimental group (thirty patients) and a control group (thirty patients). Both groups will be similar with respect to demographic and pathological profiles.

The experimental group will be fitted with a customized biomechanical device worn on the feet (AposTherapy Biomechanical System, AposTherapy - Sports and Medical Technologies Ltd., Hertzlia, Israel). The device is custom calibrated for each patient. The device allows center of pressure manipulation for all phases of the gait cycle and induces controlled perturbation during gait. The immediate effects of the device will be evaluated using center of pressure measurements, three-dimensional gait analysis, and surface electromyography. Following this, patients will be instructed to walk with the device at home on a daily basis according to a customized AposTherapy therapy protocol. They will return to the laboratory for measurements of gait pattern, muscle activation pattern, energy consumption, physical function, pain, and quality of life after three months, six months, and twelve months from the start of the therapy protocol. Data from the analyses will be used to reveal potential changes in the aforementioned measurements as a result of the study intervention.

The control group will carry out the same measurements in the laboratory over the period of one year, however without the biomechanical intervention device.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hip Osteoarthritis
  • Device: AposTherapy Biomechanical System
    The system is a rehabilitation program implementing a device comprised of four adjustable modular elements attached to foot-worn platforms that are capable of manipulating the foot's center of pressure and applying perturbation training throughout the gait cycle. The device allows for neuromuscular training during dynamic loading.
  • Other: Control
    No intervention will be prescribed to the control group during participation in the study.
  • Experimental: Experimental
    These patients will carry out a therapy program with the study intervention device.
    Intervention: Device: AposTherapy Biomechanical System
  • Active Comparator: Control
    The patients in this group will not carry out a therapy program with the study intervention device.
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women age 50 and over with unilateral or bilateral idiopathic hip osteoarthritis

Exclusion Criteria:

  • Previous surgery on the lower limbs or back
  • Previous musculoskeletal injuries and/or diseases of the lower limbs or back
  • Cognitive disabilities and/or inability to cooperate or understand study instructions
  • Vestibular problems and/or use of a walking aid
  • Neurological and/or orthopaedic and/or cardiovascular and/or pulmonary disorders or risks that may impact the patient's functional performance or limit exercise
Female
50 Years and older
No
Contact: Deborah Solomonow 972-4-8292087 dsolo@tx.technion.ac.il
Contact: Alon Wolf 972-4-8292087 alonw@tx.technion.ac.il
Israel
 
NCT01450254
0091-11-EMC
Not Provided
HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
Not Provided
Not Provided
HaEmek Medical Center, Israel
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP