Visual Feedback to Improve Balance During Walking

This study is currently recruiting participants.
Verified October 2013 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
John Jeka, University of Maryland
ClinicalTrials.gov Identifier:
NCT01690611
First received: September 12, 2012
Last updated: October 29, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Sensory Treadmill to Improve of Balance During Walking

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Change from Baseline in BESTest Score, A clinical assessment of balance [ Time Frame: Tested at 0, 4, and 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Activity Specific Balance Confidence Score [ Time Frame: Tested at 0, 4, and 8 weeks ] [ Designated as safety issue: No ]
    Questionnaire rating balance confidence

  • Change from Baseline in 6 Minute Walk Test [ Time Frame: Tested at 0, 4, and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Comfortable Walking Speed [ Time Frame: Measured daily, up to 12 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Center of Mass variability [ Time Frame: Tested daily, up to 12 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: June 2011
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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 > 25

Exclusion Criteria:

  • Current enrollment in physical rehabilitation of any kind
  • Medically unstable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690611

Contacts
Contact: Lei Ma tuf04097@temple.edu
Contact: Eric Anson, MPT eanson1@umd.edu

Locations
United States, Maryland
Collington Episcopal Life Care Community Completed
Mitchellville, Maryland, United States, 20721
United States, Pennsylvania
Pearson Hall, Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Lei Ma       tuf04097@temple.edu   
Principal Investigator: John Jeka, PhD         
Sub-Investigator: Lei Ma         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: John Jeka, PhD University of Maryland College Park
  More Information

No publications provided

Responsible Party: John Jeka, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01690611     History of Changes
Other Study ID Numbers: 366151-1
Study First Received: September 12, 2012
Last Updated: October 29, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of Maryland:
Balance Training
Walking
Falls

ClinicalTrials.gov processed this record on April 15, 2014