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Clinical Use of Andante SmartStep System in Gait Rehabilitation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2005 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00268658
First Posted: December 22, 2005
Last Update Posted: February 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soroka University Medical Center
  Purpose
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.

Condition Intervention
Ankle Injuries Femoral Neck Fractures Device: SmartStep(tm) biofeedback device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Use of Andante SmartStep System in Gait Rehabilitation

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • load bearing over the affected lower limb
  • quality/symmetry of gait
  • level of ambulation and physical independence

Estimated Enrollment: 60
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268658


Locations
Israel
Soroka University Medical Center Not yet recruiting
Beer Sheva, Israel, 00000
Contact: Daniel Plotkin, MD    972-507-633433    ctrials@gmail.com   
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Daniel Plotkin, MD Soroka University Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00268658     History of Changes
Other Study ID Numbers: sor412805ctil
First Submitted: December 21, 2005
First Posted: December 22, 2005
Last Update Posted: February 27, 2007
Last Verified: November 2005

Keywords provided by Soroka University Medical Center:
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Arthroscopy

Additional relevant MeSH terms:
Femoral Neck Fractures
Ankle Injuries
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Bunazosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs