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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
Information provided by:
Soroka University Medical Center Identifier:
First received: December 21, 2005
Last updated: February 26, 2007
Last verified: November 2005
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: 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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00268658

Soroka University Medical Center Not yet recruiting
Beer Sheva, Israel, 00000
Contact: Daniel Plotkin, MD    972-507-633433   
Sponsors and Collaborators
Soroka University Medical Center
Principal Investigator: Daniel Plotkin, MD Soroka University Medical Center
  More Information Identifier: NCT00268658     History of Changes
Other Study ID Numbers: sor412805ctil
Study First Received: December 21, 2005
Last Updated: February 26, 2007

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

Additional relevant MeSH terms:
Femoral Neck Fractures
Ankle Injuries
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 23, 2017