Visual Feedback to Improve Balance During Walking

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014