Ankle InjuriesBTPIVO-CAINCT07108491
Balance Training With Progressive Intermittent Visual Occlusions in Chronic Ankle Instability(RCT)
A study testing Balance Training with Stroboscopic Glasses and Balance Training without Glasses in people with Ankle Injuries, run by Sahmyook University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Balance Training with Stroboscopic Glasses and Balance Training without Glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Feb 2025to 4 Apr 2025
- 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 20 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- History of lower extremity fracture or musculoskeletal surgery
- Lower extremity injury within the past 3 months
- Vestibular disorders or uncorrectable visual impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read more
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.
Read the detailed description
In this study, participants were voluntarily recruited through social networking services, university bulletin boards, and in-hospital advertisements at N Hospital in Seoul. A total of 28 participants were provided with sufficient information regarding the purpose, procedures, and assessment methods of the study. After obtaining written informed consent, the participants were randomly assigned into either the experimental group (n = 14), which received balance training with progressive intermittent visual occlusions, or the control group (n = 14), which received general balance training only, using the randomization website (www.randomizer.org). Random assignment was conducted in a single-blind manner, and participants were unaware of their group allocation.
During the pre-intervention assessment, general characteristics (sex, side tested, age, height, weight, BMI, leg length) were recorded. Measures of balance, instability, muscle strength, and functional performance were taken. Each variable was measured three times to reduce error, and the average value was calculated.
Interventions were conducted individually in a designated private space, and participants were scheduled according to their availability. The experimental group participated in balance training with progressive intermittent visual occlusions twice a week for four weeks (eight sessions in total), with each session lasting 30 minutes. The control group performed the same balance training protocol without wearing stroboscopic glasses.
All interventions were administered by an experienced physical therapist with more than 10 years of clinical experience. Pre- and post-assessments were conducted by a blinded assessor who was unaware of the participants' group allocation. All procedures before and after the intervention were conducted under the same conditions. Following the intervention, balance, instability, muscle strength, and functional performance were reassessed using the same protocols as in the pretest.
During the intervention period, one participant in the experimental group dropped out due to plantar foot pain, resulting in a final sample size of 13 in the experimental group and 14 in the control group for the statistical analysis.
- Conditions
- Ankle Injuries
- Being tested
- Balance Training with Stroboscopic Glasses, Balance Training without Glasses
- Keywords
- Intermittent Visual Occlusions, Balance, Muscle Strength, Functional Performance, Chronic Ankle Instability
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Training with Stroboscopic GlassesBiological
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.
Balance Training without GlassesBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroboscopic Balance Training Group | Experimental | The experimental group performed balance training with stroboscopic glasses twice a week for four weeks Receives: 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 Receives: Biological: Balance Training without Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline (pre-intervention) and 4 weeks after completing the intervention
Secondary outcomes (3)
instability
Ankle instability was assessed using the Cumberland Ankle Instability Tool (CAIT). The CAIT is a questionnaire developed to objectively evaluate symptoms of ankle instability. It consists of a total of 9 items, with a score range from 0 to 30. A score of 28 or higher indicates ankle stability, while a score of 24 or lower indicates ankle instability.
Measured: At baseline (pre-intervention) and 4 weeks after completing the intervention
muscle strength
Ankle muscle strength was measured using a handheld dynamometer. Participants lay supine on a table, maintaining a straight position with the ankle and knee fully extended, and the ankle positioned at approximately 10-15° of plantar flexion at the edge of the table. Plantar flexion and dorsiflexion strength were measured by attaching the handheld dynamometer to the first metatarsal area. Each participant performed three trials of a 5-second maximal isometric contraction, with a 30-second rest between trials and a 90-second rest between sets. The assessor instructed participants to repeat a trial if maximal effort was not achieved or if posture was compromised.
Measured: At baseline (pre-intervention) and 4 weeks after completing the intervention
function
Functional performance was assessed using the Side Hop Test. Participants stood on the unstable ankle and jumped side-to-side as quickly as possible between two parallel lines marked 30 cm apart. Each participant performed 10 consecutive jumps per set, completing a total of 3 sets with a 1-minute rest between sets. The test was considered complete when the participant successfully performed 10 jumps without stepping on the lines with the supporting foot or touching the ground with the non-supporting foot. The time to complete each set was recorded in seconds using a stopwatch, and the average time across the 3 sets was used for final analysis.
Measured: At baseline (pre-intervention) and 4 weeks after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start24 Feb 2025
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies 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
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miyong Jeong, Sahmyook University
- Investigators
- MIYONG JEONG, MSc, Principal investigator, Sahmyook University Graduate School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108491
- Sponsor's protocol ID
- SYU 2025-01-011-002
- Other IDs
- IRB Number
- Acronym
- BTPIVO-CAI
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07108491
- Acronym / sponsor ID
- BTPIVO-CAI / SYU 2025-01-011-002
- Conditions
- Ankle Injuries
- Keywords
- Intermittent Visual Occlusions, Balance, Muscle Strength, Functional Performance, Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 7 Aug 2025 (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.
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.
Detailed description
In this study, participants were voluntarily recruited through social networking services, university bulletin boards, and in-hospital advertisements at N Hospital in Seoul. A total of 28 participants were provided with sufficient information regarding the purpose, procedures, and assessment methods of the study. After obtaining written informed consent, the participants were randomly assigned into either the experimental group (n = 14), which received balance training with progressive intermittent visual occlusions, or the control group (n = 14), which received general balance training only, using the randomization website (www.randomizer.org). Random assignment was conducted in a single-blind manner, and participants were unaware of their group allocation.
During the pre-intervention assessment, general characteristics (sex, side tested, age, height, weight, BMI, leg length) were recorded. Measures of balance, instability, muscle strength, and functional performance were taken. Each variable was measured three times to reduce error, and the average value was calculated.
Interventions were conducted individually in a designated private space, and participants were scheduled according to their availability. The experimental group participated in balance training with progressive intermittent visual occlusions twice a week for four weeks (eight sessions in total), with each session lasting 30 minutes. The control group performed the same balance training protocol without wearing stroboscopic glasses.
All interventions were administered by an experienced physical therapist with more than 10 years of clinical experience. Pre- and post-assessments were conducted by a blinded assessor who was unaware of the participants' group allocation. All procedures before and after the intervention were conducted under the same conditions. Following the intervention, balance, instability, muscle strength, and functional performance were reassessed using the same protocols as in the pretest.
During the intervention period, one participant in the experimental group dropped out due to plantar foot pain, resulting in a final sample size of 13 in the experimental group and 14 in the control group for the statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Stroboscopic Balance Training Group | Experimental | Biological: Balance Training with Stroboscopic GlassesThe experimental group performed balance training with stroboscopic glasses twice a week for four weeks |
| Control Group (General Balance Training) | Active comparator | Biological: Balance Training without GlassesThe control group performed the same balance training twice a week for four weeks |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- History of lower extremity fracture or musculoskeletal surgery
- Lower extremity injury within the past 3 months
- Vestibular disorders or uncorrectable visual impairments
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 |
|---|---|---|
| Balance Training with Stroboscopic GlassesThe 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. | Biological | Stroboscopic Balance Training Group |
| Balance Training without GlassesThe 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. | Biological | Control Group (General Balance Training) |
Primary outcome
dynamic balance
Time frame: At baseline (pre-intervention) and 4 weeks after completing the intervention
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.
Static balance
Time frame: At baseline (pre-intervention) and 4 weeks after completing the intervention
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.
3 secondary outcomes
instability
Time frame: At baseline (pre-intervention) and 4 weeks after completing the intervention
muscle strength
Time frame: At baseline (pre-intervention) and 4 weeks after completing the intervention
function
Time frame: At baseline (pre-intervention) and 4 weeks after completing the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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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.
MIYONG JEONG, MSc principal investigator
Sahmyook University Graduate School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training with Stroboscopic Glasses and Balance Training without Glasses in people with Ankle Injuries, run by Sahmyook University at 1 site in South Korea.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Aug 2025. 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 South Korea. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
dynamic balance (time frame: At baseline (pre-intervention) and 4 weeks after completing the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2025.