NCT01266382

Brief Summary

The purpose of the study is to examine the effect of a new biomechanical device and treatment methodology (AposTherapy) on gait patterns, pain, function and quality of life of patients with musculoskeletal and neurological disorders. Based on previous reports the investigators hypothesis that this therapy will have a positive effect on these measurements.

Trial Health

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Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
Last Updated

December 24, 2010

Status Verified

July 1, 2009

First QC Date

December 22, 2010

Last Update Submit

December 23, 2010

Conditions

Outcome Measures

Primary Outcomes (3)

  • Spatio-temporal Gait parameters

  • WOMAC

  • SF-36

Secondary Outcomes (3)

  • FAOS questionnaire

  • Oswestry questionnaire

  • Clinical measurements

Interventions

a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology. patient are instructed to walk indoor with the device. time of exercise is gradually increase

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis
  • Lower limb joint replacement
  • Lower limbs fractures
  • Spinal disorders including LBP w/wo refered symptoms, radiculopathy, spinal stenosis
  • ligaments tear
  • Meniscal tears

You may not qualify if:

  • lack of balance (3 falls in the last year)
  • incapable to complete a questionnaire •\>age 85

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AposTherapy center

Herzliya, 46733, Israel

RECRUITING

Related Publications (1)

  • Segal G, Bar-Ziv Y, Velkes S, Benkovich V, Stanger G, Debbi EM, Debi R, Mor A, Elbaz A. A non-invasive biomechanical device and treatment for patients following total hip arthroplasty: results of a 6-month pilot investigation. J Orthop Surg Res. 2013 May 21;8:13. doi: 10.1186/1749-799X-8-13.

MeSH Terms

Conditions

OsteoarthritisSpinal DiseasesNervous System Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone Diseases

Central Study Contacts

Ganit Segal, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 24, 2010

Last Updated

December 24, 2010

Record last verified: 2009-07

Locations