Clinical Use of Andante SmartStep System in Gait Rehabilitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00268658
First received: December 21, 2005
Last updated: February 26, 2007
Last verified: November 2005

December 21, 2005
February 26, 2007
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  • load bearing over the affected lower limb
  • quality/symmetry of gait
  • level of ambulation and physical independence
Same as current
Complete list of historical versions of study NCT00268658 on ClinicalTrials.gov Archive Site
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Clinical Use of Andante SmartStep System in Gait Rehabilitation
Clinical Use of Andante SmartStep System in Gait Rehabilitation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ankle Injuries
  • Femoral Neck Fractures
Device: SmartStep(tm) biofeedback device
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
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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
Both
18 Years to 85 Years
No
Israel
 
NCT00268658
sor412805ctil
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Soroka University Medical Center
Not Provided
Principal Investigator: Daniel Plotkin, MD Soroka University Medical Center
Soroka University Medical Center
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP