Back to resultsClinical Use of Andante SmartStep System in Gait Rehabilitation
Primary Purpose
Ankle Injuries, Femoral Neck Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SmartStep(tm) biofeedback device
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Injuries focused on measuring Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Arthroscopy
Eligibility Criteria
Inclusion Criteria: Rehabilitation after operation Patient is allowed full weight bearing Patient is motivated and able to communicate and understands orders Patient is able to walk 10 meters Patient filled out agreement and consent form Exclusion Criteria: Activity limitation due to medical disorder, medications, or emotional status. Pain markedly obstructs gait ability Documented peripheral neuropathy Functional limitation prior to the current condition Premorbid, ongoing major depression or psychosis Multiple/pathological fractures Serious early complications Terminally ill patients Pregnant women Participation in current or recent (within 60 days prior to surgery) clinical trial
Sites / Locations
- Soroka University Medical Center
Outcomes
Primary Outcome Measures
load bearing over the affected lower limb
quality/symmetry of gait
level of ambulation and physical independence
Secondary Outcome Measures
Full Information
NCT ID
NCT00268658
First Posted
December 21, 2005
Last Updated
February 26, 2007
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00268658
Brief Title
Clinical Use of Andante SmartStep System in Gait Rehabilitation
Official Title
Clinical Use of Andante SmartStep System in Gait Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
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
Soroka University Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home.
Detailed Description
To evaluate the effectiveness of the biofeedback gait training device as a biofeedback training therapeutic tool in improving body-weight bearing over the affected lower limb, quality of gait, level of ambulation and physical independence during rehabilitation, in patients after orthopedic procedures during gait therapy training, and as a biofeedback device for self-training at home.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries, Femoral Neck Fractures
Keywords
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Arthroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
SmartStep(tm) biofeedback device
Primary Outcome Measure Information:
Title
load bearing over the affected lower limb
Title
quality/symmetry of gait
Title
level of ambulation and physical independence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rehabilitation after operation
Patient is allowed full weight bearing
Patient is motivated and able to communicate and understands orders
Patient is able to walk 10 meters
Patient filled out agreement and consent form
Exclusion Criteria:
Activity limitation due to medical disorder, medications, or emotional status.
Pain markedly obstructs gait ability
Documented peripheral neuropathy
Functional limitation prior to the current condition
Premorbid, ongoing major depression or psychosis
Multiple/pathological fractures
Serious early complications
Terminally ill patients
Pregnant women
Participation in current or recent (within 60 days prior to surgery) clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Plotkin, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
00000
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Plotkin, MD
Phone
972-507-633433
Email
ctrials@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Use of Andante SmartStep System in Gait Rehabilitation
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