- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690611
Visual Feedback to Improve Balance During Walking
April 19, 2016 updated by: John Jeka, Temple University
Sensory Treadmill to Improve of Balance During Walking
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Mitchellville, Maryland, United States, 20721
- Collington Episcopal Life Care Community
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19122
- Pearson Hall, Temple University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Individuals will walk at a "comfortable speed" on a treadmill without holding on to the hand rails.
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.
|
Individuals will walk at a "comfortable speed" on a treadmill without holding on to the hand rails.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Tested at 0, 4, and 8 weeks
|
|
Change from Baseline in Berg Balance Test Score
Time Frame: Test will be given at 0, 4, and 8 weeks
|
Test will be given at 0, 4, and 8 weeks
|
|
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Change from Baseline in Activity Specific Balance Confidence Score
Time Frame: Tested at 0, 4, and 8 weeks
|
Questionnaire rating balance confidence
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Tested at 0, 4, and 8 weeks
|
|
Change from Baseline in 6 Minute Walk Test
Time Frame: Tested at 0, 4, and 8 weeks
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Tested at 0, 4, and 8 weeks
|
|
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Change from Baseline in Comfortable Walking Speed
Time Frame: Measured daily, up to 12 days
|
This value is determined for each training session
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Measured daily, up to 12 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Tested at 0, 4, and 8 weeks
|
|
Change from Baseline in Overground Walking Speed
Time Frame: Tested at 0, 4, and 8 weeks
|
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.
|
Tested daily, up to 12 days
|
|
Change from Baseline in Power spectral density
Time Frame: Tested daily, up to 12 days
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This measure is derived from recorded body position during each training repetition for each of up to 12 days of training.
|
Tested daily, up to 12 days
|
|
Change from Baseline in Single/Dual Tasking ability
Time Frame: Tested at 0, 4, and 8 weeks
|
Tested at 0, 4, and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John Jeka, PhD, Temple University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
September 12, 2012
First Submitted That Met QC Criteria
September 18, 2012
First Posted (Estimate)
September 24, 2012
Study Record Updates
Last Update Posted (Estimate)
April 21, 2016
Last Update Submitted That Met QC Criteria
April 19, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 366151-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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