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

Hip Osteoarthritis Clinical Trial

Official title:

Effects of Foot Center of Pressure Manipulation on Hip Biomechanics, Muscle Activation Patterns, and Energy Consumption During Gait in Hip Osteoarthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450254
• Other study ID #: 0091-11-EMC
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: July 6, 2015
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

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.

Locations

Country	Name	City	State
Israel	Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months	No
Primary	Change from Baseline in Muscle Activation Patterns at 3 months, 6 months, and 12 months	Surface electromyographic analysis of muscle activation patterns.	From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months	No
Secondary	Change from Baseline in Physical Function at 3 months, 6 months, and 12 months	Self-evaluation questionnaires.; Physical function tests.; Energy consumption measurements.	From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months	No
Secondary	Change from Baseline in Pain at 3 months, 6 months, and 12 months	Self-evaluation questionnaires.	From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months	No
Secondary	Change from Baseline in Quality of Life Assessments at 3 months, 6 months, and 12 months	Self-evaluation questionnaires.	From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months	No