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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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.

Condition Intervention
Hip Osteoarthritis
Device: AposTherapy Biomechanical System
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Foot Center of Pressure Manipulation on Hip Biomechanics, Muscle Activation Patterns, and Energy Consumption During Gait in Hip Osteoarthritis Patients

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
These patients will carry out a therapy program with the study intervention device.
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.
Active Comparator: Control
The patients in this group will not carry out a therapy program with the study intervention device.
Other: Control
No intervention will be prescribed to the control group during participation in the study.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450254

Contacts
Contact: Deborah Solomonow 972-4-8292087 dsolo@tx.technion.ac.il
Contact: Alon Wolf 972-4-8292087 alonw@tx.technion.ac.il

Locations
Israel
Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology Not yet recruiting
Haifa, Israel
Contact: Deborah Solomonow    972-4-8292087    dsolo@tx.technion.ac.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01450254     History of Changes
Other Study ID Numbers: 0091-11-EMC
Study First Received: October 3, 2011
Last Updated: October 10, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Hip Osteoarthritis
Gait Patterns
Neuromuscular retraining

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014