Other FallNCT01690611
Visual Feedback to Improve Balance During Walking
A study testing Treadmill Walking and Visual Feedback in people with Other Fall and Patient Falls, run by Temple University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Other Fall, Patient Falls
- What is being tested?
- Treadmill Walking and Visual Feedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Current enrollment in physical rehabilitation of any kind
- Medically unstable
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Collington Episcopal Life Care Community
Mitchellville, Maryland, 20721
Pearson Hall, Temple University
Philadelphia, Pennsylvania, 19122
About this study
Official title: 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.
- Conditions
- Other Fall, Patient Falls
- Being tested
- Treadmill Walking, Visual Feedback
- Keywords
- Balance Training, Walking, Falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill WalkingProcedure or surgery
Individuals will walk at a "comfortable speed" on a treadmill without holding on to the hand rails.
Visual FeedbackOther
Real time feedback regarding body motion while walking.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Treadmill Walking; Other: 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. Receives: Procedure: Treadmill Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in BESTest Score, A clinical assessment of balance
Balance Evaluation System Test (BESTest)
Measured: Tested at 0, 4, and 8 weeks
Change from Baseline in Berg Balance Test Score
Measured: Test will be given at 0, 4, and 8 weeks
Change from Baseline in Activity Specific Balance Confidence Score
Questionnaire rating balance confidence
Measured: Tested at 0, 4, and 8 weeks
Change from Baseline in 6 Minute Walk Test
Measured: Tested at 0, 4, and 8 weeks
Change from Baseline in Comfortable Walking Speed
This value is determined for each training session
Measured: Measured daily, up to 12 days
Secondary outcomes (5)
Change from Baseline in Muscle Strength
Strength of major muscles in the legs and trunk will be measured
Measured: Tested at 0, 4, and 8 weeks
Change from Baseline in Overground Walking Speed
Measured: Tested at 0, 4, and 8 weeks
Change from Baseline in Center of Mass variability
This measure is derived from recorded body position during each training repetition for each of up to 12 days of training.
Measured: Tested daily, up to 12 days
Change from Baseline in Power spectral density
This measure is derived from recorded body position during each training repetition for each of up to 12 days of training.
Measured: Tested daily, up to 12 days
Change from Baseline in Single/Dual Tasking ability
Measured: Tested at 0, 4, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startJun 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland
- Responsible party
- Principal investigator, John Jeka, Temple University
- Investigators
- John Jeka, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690611
- Sponsor's protocol ID
- 366151-1
- Status last verified
- Apr 2016
- First submitted
- 12 Sep 2012
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30348198
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Treadmill to Improve of Balance During Walking
- ClinicalTrials.gov ID
- NCT01690611
- Acronym / sponsor ID
- 366151-1
- Conditions
- Other Fall, Patient Falls
- Keywords
- Balance Training, Walking, Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- University of Maryland
- Study start
- Jun 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking & Visual Feedback | Experimental | Procedure: Treadmill Walking, Other: Visual FeedbackIndividuals 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. |
| Walking & No Visual Feedback | Active comparator | Procedure: Treadmill WalkingIndividuals in this arm will walk on a treadmill without viewing real time visual feedback regarding their body motion. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Current enrollment in physical rehabilitation of any kind
- Medically unstable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill WalkingIndividuals will walk at a "comfortable speed" on a treadmill without holding on to the hand rails. | Procedure or surgery | Walking & No Visual Feedback, Walking & Visual Feedback |
| Visual FeedbackReal time feedback regarding body motion while walking. | Other | Walking & Visual Feedback |
Primary outcome
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
5 secondary outcomes
Change from Baseline in Muscle Strength
Time frame: Tested at 0, 4, and 8 weeks
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
Change from Baseline in Power spectral density
Time frame: Tested daily, up to 12 days
Change from Baseline in Single/Dual Tasking ability
Time frame: Tested at 0, 4, and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Derived from this study: PubMed 30348198Anson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Jeka, PhD principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Walking and Visual Feedback in people with Other Fall and Patient Falls, run by Temple University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in BESTest Score, A clinical assessment of balance (time frame: Tested at 0, 4, and 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016; AzTrials last refreshed its copy on 27 Oct 2026.