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Gait Characteristics Following a Fall

This study is currently recruiting participants.
Verified June 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01631604
First received: June 28, 2012
Last updated: July 5, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to quantify the safety degree of the patient's gait, to detect the reason for the fall and quantify the biomechanical parameters related to fall. This study also aims to evaluate the effect of different rehabilitation treatments and their effect on the risk of falling.


Condition Intervention
Motor Impairments
Orthopaedic Injuries
Neurological Conditions
 Device: Walking aids and devices
Drug: Muscle/nerve injection
Procedure: Corrective surgery
Other: Physical therapy treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
Official Title: Quantification of Gait Parameters and Muscle Activation Patterns Following a Fall

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Gait kinematics
    Joint angles, velocities and accelerations


Secondary Outcome Measures:
  • Muscle activation patterns
    Dynamic EMG of various muscles.


Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Walking aids and devices
    Walking aids, e.g. braces, canes,orthoses, prosthetics, etc.
    Drug: Muscle/nerve injection
    Injection to muscle or nerve
    Other Names:
    • Botulinum toxin
    • Marcaine
    Procedure: Corrective surgery
    correction of spinal and bony deformities, muscle transfer, tendon elongation etc.
    Other Names:
    • Knee arthroscopy, meniscectomy and chondroplasty
    • Anterior cruciate ligament reconstruction
    • Knee replacement
    • Repair of femoral neck fracture
    • Repair of trochanteric fracture
    • Debridement of skin/muscle/bone/fracture
    • Knee arthroscopy repair of both menisci
    • Hip replacement
    • Repair of ankle fracture (bimalleolar type)
    • Lumbar spinal fusion
    • Low back intervertebral disc surgery
    • Repair of femoral shaft fracture
    Other: Physical therapy treatment
Detailed Description:

In this study, patients suffering from motor disabilities as a result of orthopedic or neurologic impairments will be tested at the gait and motion laboratory. Each patient will be secured with a ceiling-mounted safety harness and will walk on the path wearing passive light-reflecting markers and surface electrodes. High-speed cameras will record the subject's movements and the markers will be tracked to produce data of joint angles, velocities and accelerations. Dynamic EMG will be recorded from various muscles.

During the examination, the gait of the subjects will be disturb by either (i) a visual or sound signal that requires the subject to stop immediately, or (ii) walking different terrains, or (iii) tying a string to the foot and pulling it shortly to induce a trip.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals suffering from gait impairment following injury to the central or peripheral nervous system, as well as following orthopedic injuries. The subjects will be able to understand and independently sign a consent form.

Exclusion Criteria:

  • Subjects who are unable to understand and independently sign a consent form
  • Subjects who are wheelchair bound.
  • Pregnant women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631604

Contacts
Contact: Sigal Portnoy, Ph.D. 97225844492 sigalp@hadassah.org.il

Locations
Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91240
Contact: Portnoy         sigalp@hadassah.org.il    
Principal Investigator: Isabella Schwartz, MD            
Sub-Investigator: Sigal Portnoy, Ph.D.            
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01631604     History of Changes
Other Study ID Numbers: Fall-HMO-CTIL
Study First Received: June 28, 2012
Last Updated: July 5, 2012
Health Authority: Israel: Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
risk of falling
gait patterns
muscle activity
fall prevention
motor impairment

Additional relevant MeSH terms:
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013