Clinical Use of Andante SmartStep System in Gait Rehabilitation

Femoral Neck Fractures Clinical Trial

Official title:

Clinical Use of Andante SmartStep System in Gait Rehabilitation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00268658
• Other study ID #: sor412805ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: December 21, 2005
• Last updated: February 26, 2007

Study information

• Verified date: November 2005
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Femoral Neck Fractures

Intervention

Device:
• SmartStep(tm) biofeedback device

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	load bearing over the affected lower limb
Primary	quality/symmetry of gait
Primary	level of ambulation and physical independence