Intermittent Visual Perturbations to Enhance Balance Training

NCT06804512 | Recruiting Early Phase 1

• 2 other identifiers: IRB2023022042R01NS104772-06A1
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Balance

Keywords

walking balance; gait

Outcome Measures

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.

  Each subject completes the study in two weeks

Secondary Outcomes (1)

• Balance Changes Between Static, Single Leg Standing on the Day of Training and Follow-up

  Each subject completes the study in two weeks

Study Arms (9)

Control - No Goggles

PLACEBO COMPARATOR

Participants will complete the balance beam walking practice without any changes to vision.

Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking

Intervention - Goggles Worn But Turned Off

EXPERIMENTAL

Participants will complete the balance beam walking practice while wearing the goggles, but they will not be turned on.

Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking

Intervention - Vision for 3.75s and Occlusion for 1.5s

EXPERIMENTAL

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 3.75s, and the occlusion time will be set to 1.5s for the duration of the practice time.

Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking

Intervention - Vision for 7.5s and Occlusion for 0.75s

EXPERIMENTAL

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 0.75s for the duration of the practice time.

Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking

Intervention - Vision for 7.5s and Occlusion for 1.5s

EXPERIMENTAL

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time.

Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking

Intervention - Vision for 7.5s and Occlusion for 3s

EXPERIMENTAL

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 3s for the duration of the practice time.

Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking

Intervention - Vision for 15s and Occlusion for 1.5s

EXPERIMENTAL

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 15s, and the occlusion time will be set to 1.5s for the duration of the practice time.

Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking

Intervention - Low Visible Light Transmission

EXPERIMENTAL

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. The visible light transmission will be set to a low value around 20% instead of total blackout for the occlusion time.

Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking

Intervention - High Visible Light Transmission

EXPERIMENTAL

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. The visible light transmission will be set to a high value around 90% instead of total blackout for the occlusion time.

Device: Visual Occlusion Goggles; Behavioral: Balance Beam Walking

Interventions

Balance Beam Walking BEHAVIORAL

Participants will walk on a treadmill mounted balance beam to assess their balance

Control - No Goggles; Intervention - Goggles Worn But Turned Off; Intervention - High Visible Light Transmission; Intervention - Low Visible Light Transmission; Intervention - Vision for 15s and Occlusion for 1.5s; Intervention - Vision for 3.75s and Occlusion for 1.5s; Intervention - Vision for 7.5s and Occlusion for 0.75s; Intervention - Vision for 7.5s and Occlusion for 1.5s; Intervention - Vision for 7.5s and Occlusion for 3s

Visual Occlusion Goggles DEVICE

The 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.

Also known as: Senaptec

Control - No Goggles; Intervention - Goggles Worn But Turned Off; Intervention - High Visible Light Transmission; Intervention - Low Visible Light Transmission; Intervention - Vision for 15s and Occlusion for 1.5s; Intervention - Vision for 3.75s and Occlusion for 1.5s; Intervention - Vision for 7.5s and Occlusion for 0.75s; Intervention - Vision for 7.5s and Occlusion for 1.5s; Intervention - Vision for 7.5s and Occlusion for 3s

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major cognitive disorder that interferes with independence, based on affirmative response (always/usually/sometimes) to the following question: "As a result of confusion or memory loss, how often do you need assistance with day-to-day activities such as cooking, cleaning, taking medications, driving, or paying bills? Would you say it is 1) Always; 2) Usually; 3) Sometimes; 4) Rarely; or 5) Never".
• 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.
• Low vision that cannot be corrected by wearing contact lens. Low vision will be operationally defined as visual acuity less than 20/70 on standard eye chart, or difficulty perform complex walking tasks due to visual conditions affecting accurate navigation around and over obstacles (self-reported or observed by examiner). The goggles to be used in the study do not permit eyeglasses while using them.
• Illiterate or non-English speaking, due to the likelihood of difficulties following protocol instructions.

Sponsors & Collaborators

• University of Florida: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

The University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

Central Study Contacts

Daniel P Ferris, Ph.D.

CONTACT

734-834-0379; dferris@bme.ufl.edu

Ethan T Swierski, B.S.

CONTACT

716-399-7761; eswierski@ufl.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of 9 different training conditions. The intervention is walking on a treadmill mounted balance beam while wearing goggles that can perturb vision intermittently.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 3, 2025
• Study Start: August 20, 2024
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)