NCT07067931

Brief Summary

The aim of this study is to investigate the effects of an 8-week combined balance and plyometric exercise program using stroboscopic glasses on muscle morphology, dynamic balance, and proprioception in athletes with a history of ankle sprains. The primary objective is to assess the effectiveness of innovative rehabilitation strategies and their integration into clinical practice. Ultimately, the study seeks to accelerate recovery, reduce recurrence risk, and support long-term functional outcomes. Additionally, the findings are expected to fill current gaps in the literature on muscle architecture and performance, contributing scientifically to rehabilitation protocols. Hypotheses: Hypothesis 1: Stroboscopic visual feedback exercise training affects ankle muscle architecture in athletes. Hypothesis 2: Stroboscopic visual feedback exercise training affects dynamic balance in athletes. Hypothesis 3: Stroboscopic visual feedback exercise training affects ankle proprioception in athletes. Hypothesis 4: Stroboscopic visual feedback exercise training affects postural stability in athletes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

Same day

First QC Date

July 6, 2025

Last Update Submit

July 6, 2025

Conditions

Keywords

chronic ankle instabiltystroboscopic visionmuscle architecturepiliometric

Outcome Measures

Primary Outcomes (4)

  • Muscle Architecture Assessment

    Muscle architectural variables will be assessed using an HS60 (Samsung Medicine, Gangwon-do, Korea) ultrasound system equipped with a 5-13 MHz linear probe. Muscle cross-sectional area (MCA) measurements of the ankle circumference muscles will be performed under two different conditions, resting and maximal voluntary contraction (MVC), using the B-mode (brightness mode) ultrasound method. All measurements will be completed under these two conditions. Ultrasound imaging procedures will be performed by a researcher physical therapist experienced in musculoskeletal ultrasound.

    1 hour

  • Dynamic Balance Assessment

    The Y balance test, a short and practical variation of the star balance test, will be used to assess dynamic stability. Athletes will perform the Y balance test according to the test procedures defined by Plisky et al. Three white bands, each 125 cm in length, will be affixed to the ground to form a Y shape, with the small angle at 90° and the two larger angles at 135°, and centimeter-scale markings will be added to the bands by hand.Participants will be positioned at the center of the apparatus with the second phalanges of the extremity being tested in the coronal plane and the metatarsophalangeal joints in the sagittal plane, both aligned with the midline. Participants will be asked to stand with their hands at the level of the iliac crest, adjacent to their bodies, and with the foot to be measured on the ground, to reach out with the other foot in the anterior, posteromedial, and posterolateral directions, once in each direction, and to lightly touch the final point they can reach.

    15 minute

  • Proprioception Assessment

    An ankle joint position sense test will be administered to assess deficiencies in ankle proprioception. An electronic goniometer will be used to assess ankle joint position sense. The reliability of this test among recreational athletes with ankle instability has been reported as ICC = 0.94-0.98 \[45\]. Athletes will be seated with their knees flexed at 90°, and their eyes will be closed to eliminate visual cues. The ankle subtalar joint (STJN) will be held in a neutral position, and the goniometer will be set to zero. The ankle will be passively moved through 10° dorsiflexion, 10° eversion, 15° plantar flexion, or 15° inversion, and then returned to the neutral position \[46\]. Participants will then be asked to actively perform these movements as closely as possible to the previous movements. Three repeated measurements will be taken for each test angle, and deviations from the target angle will be recorded.

    15 minute

  • Postural Stability Assessment

    Athletes' postural stability and center of pressure (CoP) assessments will be performed using the Prokin force platform (Prokin PK 252). The Prokin PK 252 is a proprioceptive system used for static and dynamic balance assessment and training. In this study, the "Static and Dynamic Stability Assessment Program" will be used to provide detailed and accurate data on participants' static standing posture through the stabilometry platform and sensors placed on the body \[47\]. During the test, participants' standing position will be determined with their feet shoulder-width apart, and their foot positions will be aligned at equal distances from the origin point, using the lines on the platform's x and y axes as references.First, a single-leg static stability test will be performed. This test will be administered in two sub-tests: with eyes open and with eyes closed.

    20 minute

Secondary Outcomes (2)

  • Foot and Ankle Ability Measure (FAAM)

    15 minute

  • Cumberland Ankle Instability Tool (CAIT)

    10 minute

Study Arms (3)

The non-stroboscopic group

EXPERIMENTAL

The non-stroboscopic group will perform the exercises without glasses. The exercise training groups will follow an 8-week program, two sessions per week, involving combined balance and plyometric exercises. Plyometric training emphasizes the stretch-shortening cycle of the muscle-tendon complex, enhancing elastic capacity and neuromuscular responsiveness. Therefore, these exercises are often referred to as reactive neuromuscular training \[46\]. The program combines plyometric jumps and landings with balance-enhancing movements, all performed on the affected extremity. The program consists of three main phases: a warm-up, the main training session, and a cool-down. The warm-up includes 5 minutes of slow jogging and 5 minutes of high-knee running. The main session involves progressively intensified combined balance and plyometric exercises. The cool-down includes 5 minutes of low-intensity running followed by static stretching exercises targeting lumbar extensors, hamstrings, quadriceps

Other: Exercise

The stroboscopic group

EXPERIMENTAL

The stroboscopic group will perform all exercises wearing stroboscopic glasses (SENAPTEC, Beaverton, Oregon). These glasses use liquid crystal lenses that alternate between transparent and (nearly) opaque states via electric current.a mid-range opacity setting will be used to avoid extreme visual deprivation \[50,51\]. Plyometric training emphasizes the stretch-shortening cycle of the muscle-tendon complex, enhancing elastic capacity and neuromuscular responsiveness. Therefore, these exercises are often referred to as reactive neuromuscular training \[46\]. The program combines plyometric jumps and landings with balance-enhancing movements, all performed on the affected extremity. The program consists of three main phases: a warm-up, the main training session, and a cool-down. Exercise volume, repetitions, and rest intervals are systematically planned. Each set is followed by 15-30 seconds of rest. Intensity progresses from low to moderate throughout the program.

Other: Exercise stroboscopic

Control group

OTHER

The control group will continue with their routine training program and will not participate in any intervention.

Other: training

Interventions

In this study, balance and plyometric exercises will be performed by one group using stroboscopic glasses.

The stroboscopic group

routine training program

Control group

balance and plyometric exercises

The non-stroboscopic group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least 5 years of active participation in any sports branch.
  • At least two significant LAS incidents associated with inflammatory symptoms (pain, swelling).
  • Most recent sprain occurred at least 3 months before study commencement.
  • Feeling of ankle giving way at least twice in the past 6 months.
  • No history of surgical intervention affecting lower extremity sensorimotor function and no history of ankle fractures.
  • Cumberland Ankle Instability Tool (CAIT) score ≤25.
  • Foot and Ankle Ability Measure (FAAM) score below 90%.
  • FAAM Sports subscale score below 80%.

You may not qualify if:

  • History of any ankle fracture.
  • Surgical intervention or systemic disease affecting lower extremity sensorimotor function.
  • History of neurological disorders.
  • Acute musculoskeletal injury to the lower extremity within the last month.
  • Visual or vestibular disorders affecting balance or coordination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
SPONSOR

Study Record Dates

First Submitted

July 6, 2025

First Posted

July 16, 2025

Study Start

February 15, 2025

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations