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

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
AposTherapy Biomechanical System
Control
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Hip Osteoarthritis, Gait Patterns, Neuromuscular retraining

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

These patients will carry out a therapy program with the study intervention device.

The patients in this group will not carry out a therapy program with the study intervention device.

Outcomes

Primary Outcome Measures

Change from Baseline in Gait Patterns at 3 months, 6 months, and 12 months
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
Surface electromyographic analysis of muscle activation patterns.

Secondary Outcome Measures

Change from Baseline in Physical Function at 3 months, 6 months, and 12 months
Self-evaluation questionnaires. Physical function tests. Energy consumption measurements.
Change from Baseline in Pain at 3 months, 6 months, and 12 months
Self-evaluation questionnaires.
Change from Baseline in Quality of Life Assessments at 3 months, 6 months, and 12 months
Self-evaluation questionnaires.

Full Information

First Posted
October 3, 2011
Last Updated
July 6, 2015
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT01450254
Brief Title
Effects of Foot Center of Pressure Manipulation on Hip Osteoarthritis Patients During Gait
Official Title
Effects of Foot Center of Pressure Manipulation on Hip Biomechanics, Muscle Activation Patterns, and Energy Consumption During Gait in Hip Osteoarthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to: Analyze the short-term effects of external center of pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait on: Gait parameters (spatiotemporal, kinematic, and kinetic) Muscle activation patterns of the lower limbs and back 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: Gait parameters (spatiotemporal, kinematic, and kinetic) Motor learning and muscle activation patterns Energy consumption Pain, physical function, and quality of life The hypotheses of the study, in reference to the aforementioned study objectives are: Changes in foot center of pressure will have an immediate effect on gait parameters and muscle activation patterns of the lower limbs and back. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Hip Osteoarthritis, Gait Patterns, Neuromuscular retraining

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
These patients will carry out a therapy program with the study intervention device.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The patients in this group will not carry out a therapy program with the study intervention device.
Intervention Type
Device
Intervention Name(s)
AposTherapy Biomechanical System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No intervention will be prescribed to the control group during participation in the study.
Primary Outcome Measure Information:
Title
Change from Baseline in Gait Patterns at 3 months, 6 months, and 12 months
Description
Three-dimensional gait analysis of spatiotemporal, kinetic, and kinematic parameters. Center of pressure measurements.
Time Frame
From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
Title
Change from Baseline in Muscle Activation Patterns at 3 months, 6 months, and 12 months
Description
Surface electromyographic analysis of muscle activation patterns.
Time Frame
From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Physical Function at 3 months, 6 months, and 12 months
Description
Self-evaluation questionnaires. Physical function tests. Energy consumption measurements.
Time Frame
From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
Title
Change from Baseline in Pain at 3 months, 6 months, and 12 months
Description
Self-evaluation questionnaires.
Time Frame
From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months
Title
Change from Baseline in Quality of Life Assessments at 3 months, 6 months, and 12 months
Description
Self-evaluation questionnaires.
Time Frame
From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology
City
Haifa
Country
Israel

12. IPD Sharing Statement

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

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