Clinical Use of Andante SmartStep System in Gait Rehabilitation

Soroka University Medical Center

Status: Unknown

Conditions: Femoral Neck Fractures; Ankle Injuries

Treatments: Device: SmartStep(tm) biofeedback device

Study type: Interventional

Funder types: Other

Identifiers

NCT00268658

sor412805ctil

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)