NCT07108491

Brief Summary

Based on the purpose of this study, the following hypotheses were established: There will be a significant difference in balance changes within and between groups following balance training with progressive intermittent visual occlusions compared to general balance training. There will be a significant difference in instability changes within and between groups following balance training with progressive intermittent visual occlusions compared to general balance training. There will be a significant difference in muscle strength changes within and between groups following balance training with progressive intermittent visual occlusions compared to general balance training. There will be a significant difference in functional performance changes within and between groups following balance training with progressive intermittent visual occlusions compared to general balance training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

July 22, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

Intermittent Visual OcclusionsBalanceMuscle StrengthFunctional PerformanceChronic Ankle Instability

Outcome Measures

Primary Outcomes (2)

  • dynamic balance

    Dynamic balance ability was assessed using the Y-Balance Test. The posterior-medial and posterior-lateral directions were set at 90 degrees to each other, and each was set at 135 degrees relative to the anterior direction. The directions were determined based on the supporting leg. Participants performed three practice trials followed by three test trials for each direction. All measurements were conducted barefoot, and reach distances were measured in centimeters using a measuring tape. Participants stood at the center point where the tape lines intersected and reached as far as possible in the anterior, posterior-medial, and posterior-lateral directions.

    At baseline (pre-intervention) and 4 weeks after completing the intervention

  • Static balance

    Static balance ability was assessed using the Modified Static Postural Stability Test. Participants stood on one leg with the knee fully extended and maintained a heel-raised position, lifting the heel approximately 2-3 cm off the ground. The measurement was stopped if balance was lost, and the duration of maintaining the position was recorded in seconds.

    At baseline (pre-intervention) and 4 weeks after completing the intervention

Secondary Outcomes (3)

  • instability

    At baseline (pre-intervention) and 4 weeks after completing the intervention

  • muscle strength

    At baseline (pre-intervention) and 4 weeks after completing the intervention

  • function

    At baseline (pre-intervention) and 4 weeks after completing the intervention

Study Arms (2)

Stroboscopic Balance Training Group

EXPERIMENTAL

The experimental group performed balance training with stroboscopic glasses twice a week for four weeks

Biological: Balance Training with Stroboscopic Glasses

Control Group (General Balance Training)

ACTIVE COMPARATOR

The control group performed the same balance training twice a week for four weeks

Biological: Balance Training without Glasses

Interventions

The difficulty level of intermittent visual occlusion was structured from Level 1 to Level 8 based on frequency. As the flicker speed of the lenses decreased and the frequency lowered, the difficulty increased. For example, a setting of 6 Hz means the lenses flicker six times per second, whereas 1 Hz indicates one flicker per second. Levels 1 to 5 are suitable for dynamic movements such as catching or hitting a ball, while Levels 3 to 8 are appropriate for balance and proprioceptive training. In this study, participants wore stroboscopic glasses (Senaptec Strobe, Senaptec, USA, 2016) and began at Level 1 (6 Hz). The difficulty was gradually increased each week, with the setting adjusted to Level 3 (4 Hz) in Week 2, Level 4 (3 Hz) in Week 3, and Level 5 (2.25 Hz) in Week 4 (see Table 5). The training was conducted using the standard Mode A, in which both lenses flicker simultaneously.

Stroboscopic Balance Training Group

The exercise program consisted of six types of exercises and was conducted in a 30-minute circuit training format repeated twice per session. Participants took part in two sessions per week for four weeks, totaling eight sessions. The six exercises were completed as a circuit, repeated twice per session. A 30-second rest was provided between exercises and a 2-minute rest between circuits. All exercises were conducted by a licensed physical therapist to ensure safety.

Control Group (General Balance Training)

Eligibility Criteria

Age20 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of recurrent ankle sprains within the 12 months prior to the study
  • At least two episodes of the ankle "giving way"
  • Current ankle instability, indicated by a Cumberland Ankle Instability Tool (CAIT) score of 24 or less

You may not qualify if:

  • History of lower extremity fracture or musculoskeletal surgery
  • Lower extremity injury within the past 3 months
  • Vestibular disorders or uncorrectable visual impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahmyook University

Seoul, 01795, South Korea

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • MIYONG JEONG, MSc

    Sahmyook University Graduate School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were divided into an experimental group and a control group. The experimental group performed balance exercises while wearing stroboscopic glasses, whereas the control group performed the same balance exercises without the glasses. Both groups trained twice a week for four weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student Researcher

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 7, 2025

Study Start

February 24, 2025

Primary Completion

April 4, 2025

Study Completion

April 4, 2025

Last Updated

August 7, 2025

Record last verified: 2025-08

Locations