Clinical Use of Andante SmartStep System in Gait Rehabilitation

Not Applicable

• Conditions: Ankle Injuries; Femoral Neck Fractures

• Registration Number: NCT00268658
• Lead Sponsor: Soroka University Medical Center

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.

Study Timeline

• Status Verified: 2005-11
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-21
• Study First Posted: 2005-12-22
• Last Update Submitted: 2007-02-26
• Last Update Posted: 2007-02-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
load bearing over the affected lower limb
quality/symmetry of gait
level of ambulation and physical independence

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel