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Visual Feedback to Improve Balance During Walking

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690611
First Posted: September 24, 2012
Last Update Posted: April 21, 2016
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.
Collaborator:
University of Maryland
Information provided by (Responsible Party):
John Jeka, Temple University
  Purpose
The goal of this research is to determine if real time visual feedback of body movements improves balance control more than walking on a treadmill alone. Individuals participating in this research study will be tested using a battery of clinical strength and balance assessments twice before a 4 week training period and once after the training period. The 4 week training period will consist of 12 sessions walking on a treadmill. The experimental group will see real time visual feedback regarding their body movements, and the control group will not receive this visual feedback. Following the 4 week training each participant will again be tested using the battery of clinical strength and balance assessments.

Condition Intervention
Other Fall Patient Falls Procedure: Treadmill Walking Other: Visual Feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensory Treadmill to Improve of Balance During Walking

Further study details as provided by John Jeka, Temple University:

Primary Outcome Measures:
  • Change from Baseline in BESTest Score, A clinical assessment of balance [ Time Frame: Tested at 0, 4, and 8 weeks ]
    Balance Evaluation System Test (BESTest)

  • Change from Baseline in Berg Balance Test Score [ Time Frame: Test will be given at 0, 4, and 8 weeks ]
  • Change from Baseline in Activity Specific Balance Confidence Score [ Time Frame: Tested at 0, 4, and 8 weeks ]
    Questionnaire rating balance confidence

  • Change from Baseline in 6 Minute Walk Test [ Time Frame: Tested at 0, 4, and 8 weeks ]
  • Change from Baseline in Comfortable Walking Speed [ Time Frame: Measured daily, up to 12 days ]
    This value is determined for each training session


Secondary Outcome Measures:
  • Change from Baseline in Muscle Strength [ Time Frame: Tested at 0, 4, and 8 weeks ]
    Strength of major muscles in the legs and trunk will be measured

  • Change from Baseline in Overground Walking Speed [ Time Frame: Tested at 0, 4, and 8 weeks ]
  • Change from Baseline in Center of Mass variability [ Time Frame: Tested daily, up to 12 days ]
    This measure is derived from recorded body position during each training repetition for each of up to 12 days of training.

  • Change from Baseline in Power spectral density [ Time Frame: Tested daily, up to 12 days ]
    This measure is derived from recorded body position during each training repetition for each of up to 12 days of training.

  • Change from Baseline in Single/Dual Tasking ability [ Time Frame: Tested at 0, 4, and 8 weeks ]

Enrollment: 40
Study Start Date: June 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Walking & Visual Feedback
Individuals in this arm will walk on a treadmill while viewing real time visual feedback regarding their body motions and use the visual feedback to correct their body motions.
Procedure: Treadmill Walking
Individuals will walk at a "comfortable speed" on a treadmill without holding on to the hand rails.
Other: Visual Feedback
Real time feedback regarding body motion while walking.
Active Comparator: Walking & No Visual Feedback
Individuals in this arm will walk on a treadmill without viewing real time visual feedback regarding their body motion.
Procedure: Treadmill Walking
Individuals will walk at a "comfortable speed" on a treadmill without holding on to the hand rails.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fall Prone Older Adults (history of falls or loss of balance)
  • ability to walk on the treadmill hands-free without assistance
  • Mini-Mental Status Exam > 23

Exclusion Criteria:

  • Current enrollment in physical rehabilitation of any kind
  • Medically unstable
  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): NCT01690611


Locations
United States, Maryland
Collington Episcopal Life Care Community
Mitchellville, Maryland, United States, 20721
United States, Pennsylvania
Pearson Hall, Temple University
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Temple University
University of Maryland
Investigators
Principal Investigator: John Jeka, PhD Temple University
  More Information

Responsible Party: John Jeka, Professor, Temple University
ClinicalTrials.gov Identifier: NCT01690611     History of Changes
Other Study ID Numbers: 366151-1
First Submitted: September 12, 2012
First Posted: September 24, 2012
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by John Jeka, Temple University:
Balance Training
Walking
Falls