Balance Training With Progressive Intermittent Visual Occlusions in Chronic Ankle Instability(RCT)
BTPIVO-CAI
The Effects of Balance Training With Progressive Intermittent Visual Occlusions on Balance, Instability, Muscle Strength, and Functional Performance in Patients With Chronic Ankle Instability (RCT)
2 other identifiers
interventional
28
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2025
CompletedFirst Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
August 7, 2025
CompletedAugust 7, 2025
August 1, 2025
1 month
July 22, 2025
August 6, 2025
Conditions
Keywords
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
EXPERIMENTALThe experimental group performed balance training with stroboscopic glasses twice a week for four weeks
Control Group (General Balance Training)
ACTIVE COMPARATORThe control group performed the same balance training twice a week for four weeks
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MIYONG JEONG, MSc
Sahmyook University Graduate School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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