Gait Disorders, NeurologicVISNANCT03737331
Variable Visual Stimulus as a Novel Approach for Gait Rehabilitation
A study testing Fractal visual cueing, Periodic visual cueing and Random visual cueing in people with Gait Disorders, Neurologic, run by University of Nebraska at 1 site in United States.
Trial summary
Deterioration in walking performance as a result of disease or simply as a result of aging is a serious threat to independence in older adults. In this project, the investigators propose an innovative visual stimulus, based on advanced mathematical and biological theories, with which older adults can walk in time to… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Disorders, Neurologic
- What is being tested?
- Fractal visual cueing, Periodic visual cueing and Random visual cueing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 15 Jul 2019
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be able to provide informed consent.
- Be able to walk independently without an assistive device.
- Not suffer from neurological disease.
- Not suffer from any lower limb disabilities, injuries or disease.
Who cannot join
- If diagnosed with a pathology that directly affects the musculoskeletal system such as rheumatoid arthritis, neuropathy or myopathy, vertigo, joint replacement, diabetes, stroke or other vascular problems, scoliosis, uncorrected vision problems,major surgery in the last 6 months, or acute illness.
- Any neurologic conditions or lower limb disabilities or disease.
- History of seizures, migraines or headaches, or are visually impaired.
- Subjects unable to walk unassisted or unable to perform 10 minutes of continuous walking.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska at Omaha
Omaha, Nebraska, 68182
About this study
Deterioration in walking performance as a result of disease or simply as a result of aging is a serious threat to independence in older adults. In this project, the investigators propose an innovative visual stimulus, based on advanced mathematical and biological theories, with which older adults can walk in time to improve their walking. The investigators' goal is to apply this simple, cost-effective, and novel gait rehabilitation therapy across all populations who have difficulties walking, e.g. stroke patients, fallers or those who undergo joint replacement.
Read the detailed description
Walking synchronized to a visual stimulus is commonly used for gait rehabilitation, and has been shown to alter gait parameters such as stride length and stride time in a variety of patient populations. Typically, the patient is instructed to walk by stepping on lines or other markers placed on the ground presented in a fixed, invariant distance with each other. Whilst improvements in gait parameters have been observed in these experimental conditions, the investigators submit that a fundamentally different approach could lead to much greater benefits. The investigators' laboratory has successfully shown that walking to an invariant stimulus, with no variability, runs contrary to the natural stride-to-stride fluctuations (i.e., gait variability) that are known to exist in human gait. The investigators propose that the elimination of variability from gait, as is the case when walking with invariant external cueing, will not provide the movement abilities needed by individuals with reduced mobility to navigate the real world, unpredictable environments. In this project, the investigators propose an alternative approach to rehabilitation of gait disorders with respect to external cueing that takes the natural variability of healthy gait into account. The investigators have previously shown that young and older adults when walking to an invariant stimulus, display diminished natural stride-to-stride fluctuations. Preliminary data has also shown that the natural stride-to-stride fluctuations that exist in healthy gait are altered with aging, but can also be restored to levels similar to young adults when walking to a Variable Visual Stimulus. The investigators proposed solution is then to transform the standard invariant visual cueing paradigm by using a Variable Visual Stimulus that reflects the variable movement patterns found in healthy gait. This is because the presentation of our Stimulus will be variable, but it will not be random. There will be a pattern contained within the presentation of our Stimulus that is based upon the patterns found in healthy young adults. This project will investigate the long-term effects of viewing an invariant, a random and a variable visual stimulus on gait variability in older adults. Furthermore, the investigators will investigate the retention effects at 1- and 3-months of an 8-week program. The central hypothesis is that older adults who are at risk of falling will demonstrate greater improvements in gait variability and adaptive gait tasks when walking with a Variable Visual Stimulus that reflects the variable movement patterns found in healthy gait. The impact of this project will be transformational regarding gait rehabilitation for older adults who are at risk of falls. This simple, cost-effective method would be accessible to all gait rehabilitation clinics requiring only ubiquitously available glasses.
- Conditions
- Gait Disorders, Neurologic
- Being tested
- Fractal visual cueing, Periodic visual cueing, Random visual cueing
- Keywords
- Visual, Variability, Gait, Fractals, Rehabilitation, Brain
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractal visual cueingBehavioural
Walking to an external visual fractal (i.e., pink noise) stimulus.
Periodic visual cueingBehavioural
Walking to an external visual periodic (i.e., invariant) stimulus.
Random visual cueingBehavioural
Walking to an external visual random (i.e., white noise) stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Fractal visual cueing | Experimental | This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be fractal (i.e., pink noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom. Receives: Behavioral: Fractal visual cueing |
| Periodic visual cueing | Active comparator | This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be periodic (i.e., invariant). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom. Receives: Behavioral: Periodic visual cueing |
| Random visual cueing | Sham comparator | This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be random (i.e., white noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom. Receives: Behavioral: Random visual cueing |
| Control | No intervention | Natural walking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride length
Meters
Measured: Through study completion, an average of 1 year
Stride time
Seconds
Measured: Through study completion, an average of 1 year
Stride speed
Meters/seconds
Measured: Through study completion, an average of 1 year
Cortical hemodynamics
Micromoles
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Joint angles
Radians
Measured: Through study completion, an average of 1 year
Peak torque of knee extensor muscles at 60º/s
Newton-meters
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start9 Nov 2018
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Why it stopped: Canceled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gait Disorders, NeurologicStudies 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
- Model description
- Older adults at risk of a fall will participate in an 8-week training program. There will be four groups: no stimulus (i.e., control), invariant, random and variable stimuli. The training program will consist in an 8-week program, 3 sessions per week. For each training session, participants will come to the Biomechanics Research Building for a 30-minute training session (2 x 10-minute walking trials with a 10-minute resting period in between), 3 times per week. During the training session, the subjects will be instructed to walk while viewing and synchronizing the steps with the visual stimulus. In the first session of weeks 3, 5 and 7, the subjects will undergo a reassessment of the preferred stride time, wearing the footswitches. This reassessment will be needed to recalculate the preferred stride time and incorporate it in the stimulus in use, in case it has been changed as an effect of the training.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis M Silva, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737331
- Sponsor's protocol ID
- 0395-18-FB
- Acronym
- VISNA
- Status last verified
- Aug 2024
- First submitted
- 7 Nov 2018
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stergiou N, Decker LM. Human movement variability, nonlinear dynamics, and pathology: is there a connection? Hum Mov Sci. 2011 Oct;30(5):869-88. doi: 10.1016/j.humov.2011.06.002. Epub 2011 Jul 29.
PubMed 21802756Brach JS, Wert D, VanSwearingen JM, Newman AB, Studenski SA. Use of stance time variability for predicting mobility disability in community-dwelling older persons: a prospective study. J Geriatr Phys Ther. 2012 Jul-Sep;35(3):112-7. doi: 10.1519/JPT.0b013e318243e5f9.
PubMed 22314273Brach JS, Studenski S, Perera S, VanSwearingen JM, Newman AB. Stance time and step width variability have unique contributing impairments in older persons. Gait Posture. 2008 Apr;27(3):431-9. doi: 10.1016/j.gaitpost.2007.05.016. Epub 2007 Jul 13.
PubMed 17632004Brach JS, Lowry K, Perera S, Hornyak V, Wert D, Studenski SA, VanSwearingen JM. Improving motor control in walking: a randomized clinical trial in older adults with subclinical walking difficulty. Arch Phys Med Rehabil. 2015 Mar;96(3):388-94. doi: 10.1016/j.apmr.2014.10.018. Epub 2014 Nov 10.
PubMed 25448244
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable Visual Stimulus as a Novel Approach for Gait Rehabilitation
- ClinicalTrials.gov ID
- NCT03737331
- Acronym / sponsor ID
- VISNA / 0395-18-FB
- Conditions
- Gait Disorders, Neurologic
- Keywords
- Visual, Variability, Gait, Fractals, Rehabilitation, Brain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Canceled
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 9 Nov 2018 (actual)
- 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.
Deterioration in walking performance as a result of disease or simply as a result of aging is a serious threat to independence in older adults. In this project, the investigators propose an innovative visual stimulus, based on advanced mathematical and biological theories, with which older adults can walk in time to improve their walking. The investigators' goal is to apply this simple, cost-effective, and novel gait rehabilitation therapy across all populations who have difficulties walking, e.g. stroke patients, fallers or those who undergo joint replacement.
Detailed description
Walking synchronized to a visual stimulus is commonly used for gait rehabilitation, and has been shown to alter gait parameters such as stride length and stride time in a variety of patient populations. Typically, the patient is instructed to walk by stepping on lines or other markers placed on the ground presented in a fixed, invariant distance with each other. Whilst improvements in gait parameters have been observed in these experimental conditions, the investigators submit that a fundamentally different approach could lead to much greater benefits. The investigators' laboratory has successfully shown that walking to an invariant stimulus, with no variability, runs contrary to the natural stride-to-stride fluctuations (i.e., gait variability) that are known to exist in human gait. The investigators propose that the elimination of variability from gait, as is the case when walking with invariant external cueing, will not provide the movement abilities needed by individuals with reduced mobility to navigate the real world, unpredictable environments. In this project, the investigators propose an alternative approach to rehabilitation of gait disorders with respect to external cueing that takes the natural variability of healthy gait into account. The investigators have previously shown that young and older adults when walking to an invariant stimulus, display diminished natural stride-to-stride fluctuations. Preliminary data has also shown that the natural stride-to-stride fluctuations that exist in healthy gait are altered with aging, but can also be restored to levels similar to young adults when walking to a Variable Visual Stimulus. The investigators proposed solution is then to transform the standard invariant visual cueing paradigm by using a Variable Visual Stimulus that reflects the variable movement patterns found in healthy gait. This is because the presentation of our Stimulus will be variable, but it will not be random. There will be a pattern contained within the presentation of our Stimulus that is based upon the patterns found in healthy young adults. This project will investigate the long-term effects of viewing an invariant, a random and a variable visual stimulus on gait variability in older adults. Furthermore, the investigators will investigate the retention effects at 1- and 3-months of an 8-week program. The central hypothesis is that older adults who are at risk of falling will demonstrate greater improvements in gait variability and adaptive gait tasks when walking with a Variable Visual Stimulus that reflects the variable movement patterns found in healthy gait. The impact of this project will be transformational regarding gait rehabilitation for older adults who are at risk of falls. This simple, cost-effective method would be accessible to all gait rehabilitation clinics requiring only ubiquitously available glasses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Older adults at risk of a fall will participate in an 8-week training program. There will be four groups: no stimulus (i.e., control), invariant, random and variable stimuli. The training program will consist in an 8-week program, 3 sessions per week. For each training session, participants will come to the Biomechanics Research Building for a 30-minute training session (2 x 10-minute walking trials with a 10-minute resting period in between), 3 times per week. During the training session, the subjects will be instructed to walk while viewing and synchronizing the steps with the visual stimulus. In the first session of weeks 3, 5 and 7, the subjects will undergo a reassessment of the preferred stride time, wearing the footswitches. This reassessment will be needed to recalculate the preferred stride time and incorporate it in the stimulus in use, in case it has been changed as an effect of the training.
| Arm | Type | Receives |
|---|---|---|
| Fractal visual cueing | Experimental | Behavioral: Fractal visual cueingThis stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be fractal (i.e., pink noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom. |
| Periodic visual cueing | Active comparator | Behavioral: Periodic visual cueingThis stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be periodic (i.e., invariant). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom. |
| Random visual cueing | Sham comparator | Behavioral: Random visual cueingThis stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be random (i.e., white noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom. |
| Control | No intervention | –Natural walking. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Be able to provide informed consent.
- Be able to walk independently without an assistive device.
- Not suffer from neurological disease.
- Not suffer from any lower limb disabilities, injuries or disease.
Key exclusion criteria (4 listed)
- If diagnosed with a pathology that directly affects the musculoskeletal system such as rheumatoid arthritis, neuropathy or myopathy, vertigo, joint replacement, diabetes, stroke or other vascular problems, scoliosis, uncorrected vision problems,major surgery in the last 6 months, or acute illness.
- Any neurologic conditions or lower limb disabilities or disease.
- History of seizures, migraines or headaches, or are visually impaired.
- Subjects unable to walk unassisted or unable to perform 10 minutes of continuous walking.
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 |
|---|---|---|
| Fractal visual cueingWalking to an external visual fractal (i.e., pink noise) stimulus. | Behavioural | Fractal visual cueing |
| Periodic visual cueingWalking to an external visual periodic (i.e., invariant) stimulus. | Behavioural | Periodic visual cueing |
| Random visual cueingWalking to an external visual random (i.e., white noise) stimulus. | Behavioural | Random visual cueing |
Primary outcome
Stride length
Time frame: Through study completion, an average of 1 year
Meters
Stride time
Time frame: Through study completion, an average of 1 year
Seconds
Stride speed
Time frame: Through study completion, an average of 1 year
Meters/seconds
Cortical hemodynamics
Time frame: Through study completion, an average of 1 year
Micromoles
2 secondary outcomes
Joint angles
Time frame: Through study completion, an average of 1 year
Peak torque of knee extensor muscles at 60º/s
Time frame: Through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Canceled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 21802756Stergiou N, Decker LM. Human movement variability, nonlinear dynamics, and pathology: is there a connection? Hum Mov Sci. 2011 Oct;30(5):869-88. doi: 10.1016/j.humov.2011.06.002. Epub 2011 Jul 29.
- Background: PubMed 22314273Brach JS, Wert D, VanSwearingen JM, Newman AB, Studenski SA. Use of stance time variability for predicting mobility disability in community-dwelling older persons: a prospective study. J Geriatr Phys Ther. 2012 Jul-Sep;35(3):112-7. doi: 10.1519/JPT.0b013e318243e5f9.
- Background: PubMed 17632004Brach JS, Studenski S, Perera S, VanSwearingen JM, Newman AB. Stance time and step width variability have unique contributing impairments in older persons. Gait Posture. 2008 Apr;27(3):431-9. doi: 10.1016/j.gaitpost.2007.05.016. Epub 2007 Jul 13.
- Background: PubMed 25448244Brach JS, Lowry K, Perera S, Hornyak V, Wert D, Studenski SA, VanSwearingen JM. Improving motor control in walking: a randomized clinical trial in older adults with subclinical walking difficulty. Arch Phys Med Rehabil. 2015 Mar;96(3):388-94. doi: 10.1016/j.apmr.2014.10.018. Epub 2014 Nov 10.
- Kaipust JP, McGrath D, Mukherjee M, Stergiou N. Gait variability is altered in older adults when listening to auditory stimuli with differing temporal structures. Ann Biomed Eng. 2013;41(8):1595-1603. doi:10.1007/s10439-012-0654-9.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Luis M Silva, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractal visual cueing, Periodic visual cueing and Random visual cueing in people with Gait Disorders, Neurologic, run by University of Nebraska at 1 site 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Canceled). Results are not available in the source record.
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?
Stride length (time frame: Through study completion, an average of 1 year). The study lists 4 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 NCT03737331, which also lists 4 linked publications.
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 3 Sep 2024.