NCT01690611

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

4.3 years

First QC Date

September 12, 2012

Last Update Submit

April 19, 2016

Conditions

Other FallPatient Falls

Keywords

Balance TrainingWalkingFalls

Outcome Measures

Primary Outcomes (5)

  • Change from Baseline in BESTest Score, A clinical assessment of balance

    Balance Evaluation System Test (BESTest)

    Tested at 0, 4, and 8 weeks

  • Change from Baseline in Berg Balance Test Score

    Test will be given at 0, 4, and 8 weeks

  • Change from Baseline in Activity Specific Balance Confidence Score

    Questionnaire rating balance confidence

    Tested at 0, 4, and 8 weeks

  • Change from Baseline in 6 Minute Walk Test

    Tested at 0, 4, and 8 weeks

  • Change from Baseline in Comfortable Walking Speed

    This value is determined for each training session

    Measured daily, up to 12 days

Secondary Outcomes (5)

  • Change from Baseline in Muscle Strength

    Tested at 0, 4, and 8 weeks

  • Change from Baseline in Overground Walking Speed

    Tested at 0, 4, and 8 weeks

  • Change from Baseline in Center of Mass variability

    Tested daily, up to 12 days

  • Change from Baseline in Power spectral density

    Tested daily, up to 12 days

  • Change from Baseline in Single/Dual Tasking ability

    Tested at 0, 4, and 8 weeks

Study Arms (2)

Walking & Visual Feedback

EXPERIMENTAL

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 WalkingOther: Visual Feedback

Walking & No Visual Feedback

ACTIVE COMPARATOR

Individuals in this arm will walk on a treadmill without viewing real time visual feedback regarding their body motion.

Procedure: Treadmill Walking

Interventions

Treadmill WalkingPROCEDURE

Individuals will walk at a "comfortable speed" on a treadmill without holding on to the hand rails.

Walking & No Visual FeedbackWalking & Visual Feedback
Visual FeedbackOTHER

Real time feedback regarding body motion while walking.

Walking & Visual Feedback

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current enrollment in physical rehabilitation of any kind
  • Medically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Collington Episcopal Life Care Community

Mitchellville, Maryland, 20721, United States

Location

Pearson Hall, Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (1)

  • Anson E, Thompson E, Karpen SC, Odle BL, Seier E, Jeka J, Panus PC. Visual biofeedback training reduces quantitative drugs index scores associated with fall risk. BMC Res Notes. 2018 Oct 22;11(1):750. doi: 10.1186/s13104-018-3859-7.

    PMID: 30348198DERIVED

MeSH Terms

Interventions

Feedback, Sensory

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Study Officials

  • John Jeka, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 24, 2012

Study Start

June 1, 2011

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

US(2)