Intermittent Visual Perturbations to Enhance Balance Training
ConditionBalance
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Florida
About this trial
The purpose of this research study is to determine if intermittent visual perturbations can improve balance training. The investigators will quantify differences in body movement, muscle activity, and beam walking performance during and after practice walking on a balance beam that is 1" high. The investigators will ask the participants to come to the laboratory twice (2 sessions). The first session will not last more than 3 hours. The second session will not last more than 1 hour and will be two weeks after the first session. In total, the maximum amount of time the participant would be asked to participate is 4 hours.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 18-30 years, or 65-89 years.
Ability to walk independently for 10 minutes continuously.
Willingness to be randomized to any experimental group and to participate in all aspects of study assessment and intervention
Disqualifiers
Current or recent (within 6 months) lower limb musculoskeletal injury that causes pain during walking or limits walking ability.
History of neurological injury or disability (including spinal cord injury, stroke, Parkinson's disease, or multiple sclerosis).
Difficulty communicating with study personnel.
Current enrollment in any other clinical trial.
Trial design
Design model
Parallel
Treatments tested in this trial
Visual Occlusion Goggles
DeviceThe visual occlusion goggles alternate between sight and visual occlusion in a regular and programmable pattern. Based on the electrical properties of the goggles, they are also able to have the tint adjusted instead of blacking out entirely for the occlusion times during the programmed timings.
Balance Beam Walking
BehavioralParticipants will walk on a treadmill mounted balance beam to assess their balance
Treatment groups
540 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Control - No GogglesPlacebo comparator 2 interventions
Group B: Intervention - Goggles Worn But Turned OffExperimental treatment 2 interventions
Group C: Intervention - Vision for 3.75s and Occlusion for 1.5sExperimental treatment 2 interventions
Group D: Intervention - Vision for 7.5s and Occlusion for 0.75sExperimental treatment 2 interventions
Group E: Intervention - Vision for 7.5s and Occlusion for 1.5sExperimental treatment 2 interventions
Group F: Intervention - Vision for 7.5s and Occlusion for 3sExperimental treatment 2 interventions
Group G: Intervention - Vision for 15s and Occlusion for 1.5sExperimental treatment 2 interventions
Group H: Intervention - Low Visible Light TransmissionExperimental treatment 2 interventions
Group I: Intervention - High Visible Light TransmissionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Balance Changes Between Pre and Post-Tests
The primary outcome is a change in balance between the pre-test and post-tests and the pretest and follow-up. For the pre-test, post-test, and follow-up, participants will walk on the treadmill-mounted beam for 5 minutes without wearing the goggles. The pre-test will occur before the training periods begin, the post-test will occur after the training periods, and the follow-up occurs two weeks after the the first training. Step offs and time on the beam is recorded for each trial to make balance comparisons. The step offs and time on the beam used in conjunction to get step offs per minute by dividing step offs by time on the beam. Balance will be measured in step offs per minute.
Time frame
Each subject completes the study in two weeksSecondary outcomes
1
Balance Changes Between Static, Single Leg Standing on the Day of Training and Follow-up
The secondary outcome will be a change in balance of the single legged balance between the first day and follow-up. Subjects will be asked to stand quietly with eyes open, standing barefoot on the limb of their choice, with the other limb raised so that the raised foot is near but not touching the ankle of their stance limb, looking forward, and with their arms crossed over their chest. This will be done any beam walking is done on both days. The subjects will be timed, ending when they uncross their arms, move their raised foot, move their weight bearing foot, or 45 seconds elapse. This will be done three times on each day. The times will then be compared between the first day of training and the follow-up to look for improvement.
Time frame
Each subject completes the study in two weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov