NCT01412814

Brief Summary

This study aimed to discover the biomechanics of gait pattern adaptation in patients after a total knee replacement. The first hypothesis of the project was that center-of-pressure manipulation at the foot during dynamic loading is capable of changing the forces, torques and muscle activation patterns of the lower limb. The second hypothesis of the project was that patient-specific center-of-pressure manipulation at the foot combined with repetitive perturbation training over time will improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain, quality of life and energy consumption in patients after a total knee replacement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

3.3 years

First QC Date

July 20, 2011

Last Update Submit

December 21, 2015

Conditions

Knee ArthroplastyKnee Arthritis OsteoarthritisOsteoarthritisOsteoarthritis, KneeMusculoskeletal Diseases

Keywords

Total knee arthroplastyTotal knee replacementEnd-stage knee osteoarthritisGait patternsNeuromuscular education

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Gait Patterns at 6-8 weeks, 5-6 months and 11-12 months

    Three-dimensional gait analysis of spatiotemporal, kinetic and kinematic parameters. Surface electromyographic analysis of muscle activation patterns. Center of pressure measurements and function tests.

    An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery

Secondary Outcomes (1)

  • Change from Baseline in Pain, Function and Quality of Life Assessments at 6-8 weeks, 5-6 months and 11-12 months

    An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery

Study Arms (2)

Experimental

EXPERIMENTAL

These patients will carry out the specified intervention of the study with the AposTherapy Biomechanical System in addition to the typical physical therapy regiment prescribed to them by their physician.

Device: AposTherapy Biomechanical System

Control

ACTIVE COMPARATOR

The patients within this group will also carry out the typical physical therapy program for total knee replacement as prescribed by their physician. The patients will carry out a similar therapy program to the experimental group, but without the study intervention device (placebo walking shoe).

Other: Physical Therapy Program

Interventions

AposTherapy Biomechanical SystemDEVICE

The device is 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
Physical Therapy ProgramOTHER

Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).

Control

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for first total knee arthroplasty due to end-stage knee osteoarthritis
  • Ambulatory and active patients that can participate in gait analysis

You may not qualify if:

  • Prior joint surgery of either lower extremity, with the exception of arthroscopy
  • Unsteady gait
  • Back pain
  • Neurological, pulmonary or cardiovascular pathologies or risks that may affect long-term performance
  • Inability to understand or comply with the treatment protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology

Haifa, Israel, Israel

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, KneeMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2011

First Posted

August 9, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

IL(1)