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

NCT01450254 | Completed

• 1 other identifier: 0091-11-EMC
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.Analyze the short-term effects of external center of pressure manipulation of the foot in idiopathic hip osteoarthritis patients during gait on:
2. 2.Gait parameters (spatiotemporal, kinematic, and kinetic)
3. 3.Muscle activation patterns of the lower limbs and back
4. 4.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:
5. 5.Gait parameters (spatiotemporal, kinematic, and kinetic)
6. 6.Motor learning and muscle activation patterns
7. 7.Energy consumption
8. 8.Pain, physical function, and quality of life
9. 9.Changes in foot center of pressure will have an immediate effect on gait parameters and muscle activation patterns of the lower limbs and back.
10. 10.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.

Conditions

Hip Osteoarthritis

Keywords

Hip Osteoarthritis; Gait Patterns; Neuromuscular retraining

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Change from Baseline in Physical Function at 3 months, 6 months, and 12 months

  From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months

• Change from Baseline in Pain at 3 months, 6 months, and 12 months

  From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months

• Change from Baseline in Quality of Life Assessments at 3 months, 6 months, and 12 months

  From beginning of patient participation in study, after 3 months, after 6 months, and after 12 months

Study Arms (2)

Experimental

EXPERIMENTAL

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

Device: AposTherapy Biomechanical System

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

AposTherapy Biomechanical System DEVICE

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.

Experimental

Control OTHER

No intervention will be prescribed to the control group during participation in the study.

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology

Haifa, Israel

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 12, 2011
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

IL (1)