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Clinical Trials/NCT00268658
NCT00268658
Unknown
Not Applicable

Clinical Use of Andante SmartStep System in Gait Rehabilitation

Soroka University Medical Center1 site in 1 country60 target enrollmentDecember 22, 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankle Injuries
Sponsor
Soroka University Medical Center
Enrollment
60
Locations
1
Primary Endpoint
load bearing over the affected lower limb
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 22, 2005
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

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

Outcomes

Primary Outcomes

load bearing over the affected lower limb

quality/symmetry of gait

level of ambulation and physical independence

Study Sites (1)

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