To evaluate the effectiveness of the biofeedback gait training device in improving load bearing over operated limb , during post operative gait training therapy. Effectiveness of the device will also be tested in self training at home.

Condition	Intervention
Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Arthroscopy Ankle Injuries Femoral Neck Fractures	Device: SmartStep(tm) Biofeedback device

Further study details as provided by Soroka University Medical Center:

Primary Outcomes: load bearing over the affected lower limb; quality/symmetry of gait; level of ambulation and physical independence
Expected Total Enrollment:  60

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.

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Rehabilitation after operation (listed above)
• Patient is allowed to Full Weight Bearing
• Patient is motivated able to communicate and understands orders
• Patient is able to walk 10 meters
• Patient filled agreement and consent form

Exclusion Criteria:

• Activity limitation due to medical disorder, medications, or emotional status.
• Pain markedly obstruct 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00268658

Israel
      Soroka University Medical Center, Beer-Sheva,  00000,  Israel

Study chairs or principal investigators

Daniel Plotkin, MD,  Principal Investigator,  Soroka University Medical Center   

Study ID Numbers:  10-003
Last Updated:  December 21, 2005
Record first received:  December 21, 2005
ClinicalTrials.gov Identifier:  NCT00268658
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10