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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
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00268658     History of Changes
Other Study ID Numbers: sor412805ctil
Study First Received: December 21, 2005
Last Updated: February 26, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
Leg Injuries
Bunazosin
 Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2012