The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders
Primary Purpose
Osteoarthritis, Spinal Diseases, Ligament Rupture
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
AposTherapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Primary osteoarthritis
- Lower limb joint replacement
- Lower limbs fractures
- Spinal disorders including LBP w/wo refered symptoms, radiculopathy, spinal stenosis
- ligaments tear
- Meniscal tears
Exclusion Criteria:
- lack of balance (3 falls in the last year)
- incapable to complete a questionnaire •>age 85
Sites / Locations
- AposTherapy centerRecruiting
Outcomes
Primary Outcome Measures
Spatio-temporal Gait parameters
WOMAC
SF-36
Secondary Outcome Measures
FAOS questionnaire
Oswestry questionnaire
Clinical measurements
Full Information
NCT ID
NCT01266382
First Posted
December 22, 2010
Last Updated
December 23, 2010
Sponsor
Assaf-Harofeh Medical Center
Collaborators
Apos Medical and Sports Technology Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01266382
Brief Title
The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
Collaborators
Apos Medical and Sports Technology Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Spinal Diseases, Ligament Rupture, Lower Extremity Fracture, Neurological Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
AposTherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Spatio-temporal Gait parameters
Title
WOMAC
Title
SF-36
Secondary Outcome Measure Information:
Title
FAOS questionnaire
Title
Oswestry questionnaire
Title
Clinical measurements
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primary osteoarthritis
Lower limb joint replacement
Lower limbs fractures
Spinal disorders including LBP w/wo refered symptoms, radiculopathy, spinal stenosis
ligaments tear
Meniscal tears
Exclusion Criteria:
lack of balance (3 falls in the last year)
incapable to complete a questionnaire •>age 85
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ganit Segal, MA
Email
ganitm@apos.co.il
Facility Information:
Facility Name
AposTherapy center
City
Herzliya
ZIP/Postal Code
46733
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ganit Segal
Email
ganitm@apos.co.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
23692690
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders
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