NCT00724139

Brief Summary

The aim of this study is to evaluate the outcome of specific repetitive biomechanical perturbation training on motor patterns. The first hypothesis of this project is that footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain. The second hypothesis of the project is that repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning thus conveying plasticity of existing locomotor patterns and gait strategies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

July 27, 2008

Last Update Submit

July 28, 2008

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain

    6 months

Secondary Outcomes (1)

  • would repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning

    6 months

Study Arms (1)

1

EXPERIMENTAL

patients (aged 50-75) with Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren \& Lawrence scale.

Device: : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel

Interventions

: APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, IsraelDEVICE

training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms which conveys perturbation throughout the gait cycle

1

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling older adults.
  • Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren \& Lawrence scale.
  • Ambulatory and active patients that can precipitate the gait analysis.
  • Age 50-75.
  • No prior joint replacement in the lower extremity.

You may not qualify if:

  • Knee pain due to pathologic conditions other than OA, such as rheumatoid arthritis and pseudogout.
  • Knee with flexion contracture greater than 20°.
  • Patients with hip problems, symptomatic lumbar spine disease, spinal cord.
  • Ataxic gait related to neurologic disease.
  • Patients with increased tendency to fall.
  • Lack of physical or mental ability to perform or comply with the treatment procedure.
  • Diabetes mellitus.
  • History of pathological osteoporotic fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technion Israel institute of technology

Haifa, Israel

RECRUITING

Related Publications (1)

  • Debbi EM, Wolf A, Goryachev Y, Rozen N, Haim A. Alterations in sagittal plane knee kinetics in knee osteoarthritis using a biomechanical therapy device. Ann Biomed Eng. 2015 May;43(5):1089-97. doi: 10.1007/s10439-014-1177-3. Epub 2014 Nov 7.

    PMID: 25377767DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Amir Haim, MD

CONTACT

0524262129amirhaim@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2008

First Posted

July 29, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

IL(1)