ClinicalTrials.gg
Active, not recruitingNCT07789691Updated Sep 2, 2026

Effects of Reformer Pilates and Vestibular Exercise Programs on Balance and Gait in Children With Visual Impairment

An interventional study of Equipment-Based Pilates Exercise (Reformer) and Vestibular Exercise Program in Visual Impairments, sponsored by Marmara University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Feb 2025, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study summary

This study looks at whether Reformer Pilates can help children and adolescents with visual impairment improve their balance, walking patterns, and muscle strength.

Participants are between 10 and 17 years old. They are randomly placed into one of two groups: an exercise group or a control group.

Those in the exercise group take part in 12 supervised Reformer Pilates sessions over 6 weeks, meeting twice a week. Those in the control group keep up with their usual daily activities and do not join the exercise program during this time.

Before and after the 6-week period, researchers measure each participant's balance, walking patterns, and muscle strength. They then compare how much each group changed.

02

Conditions studied

  • Visual Impairments

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Keywords

  • Pilates (Equipment-Based Pilates)
  • Vestibular Exercise
  • Balance Performance
  • Gait Biomechanics
  • Muscle Strength
  • Children
  • Adolescents
03

In context

Vision Disorders

360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.

This study's enrollment of 75 is close to the median of 78 across 244 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children and adolescents aged 10 to 17 years
  • Diagnosis of visual impairment, classified as degree 2 to 5
  • provided by a parent or legal guardian

Exclusion criteria

Exclusion Criteria:

  • Presence of an orthopedic disorder affecting balance, gait, or participation in the exercise program
  • Presence of a neurological disorder affecting balance, gait, or participation in the exercise program
  • Use of medications known to affect balance or gait
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Pilates (Equipment-Based Pilates(Reformer)) Group

    Participants in this arm received a supervised Reformer Pilates exercise program twice weekly for 6 weeks, for a total of 12 sessions

    Behavioral: Equipment-Based Pilates Exercise (Reformer)

  • Experimental
    Vestibular Exercise Group

    Participants in this group receive a supervised vestibular balance exercise program for 6 weeks, consisting of 12 sessions (two sessions per week).

    Behavioral: Vestibular Exercise Program

  • No intervention
    Control Group

    Participants in this arm continued their usual daily activities and did not receive either of the study exercise programs during the study period.

Interventions

  • BehavioralEquipment-Based Pilates Exercise (Reformer)

    Participants in this arm attended a supervised Reformer Pilates program, held twice a week for six weeks (12 sessions in total). Sessions were structured around the Reformer apparatus and followed a progressive format, with exercise difficulty gradually increasing as participants advanced through the program.

  • BehavioralVestibular Exercise Program

    Participants in this arm attended a supervised vestibular balance exercise program, held twice a week for six weeks (12 sessions in total). Exercises were performed under varying sensory conditions and progressed in difficulty as participants advanced through the program.

06

What researchers measure

Primary outcomes

  1. Static Balance Performance: Center of Pressure Sway Area

    Center of Pressure Sway Area: Static balance performance is assessed using the TekScan pressure platform. Center of pressure (COP) sway area is measured during standardized quiet standing and expressed in square centimeters (cm²) and Higher values indicate greater postural sway.

    Time frame: Baseline and post-intervention at Week 6

  2. Static Balance Performance: Center of Pressure Path Length

    Center of pressure path length is measured using the TekScan pressure platform during quiet standing, representing the total displacement distance of the center of pressure, expressed in centimeters (cm).

    Time frame: Baseline and post-intervention at Week 6

  3. Static Balance Performance: Antero-posterior Center of Pressure Excursion

    Anteroposterior center of pressure excursion is measured using the TekScan pressure platform during quiet standing, representing postural sway in the forward-backward direction, expressed in centimeters (cm).

    Time frame: Baseline and post-intervention at Week 6

  4. Static Balance Performance: Mediolateral Center of Pressure Excursion

    Medio-lateral center of pressure excursion is measured using the TekScan pressure platform during quiet standing, representing postural sway in the side-to-side direction, expressed in centimeters (cm).

    Time frame: Baseline and post-intervention at Week 6

  5. Gait - Spatiotemporal:Walking Speed

    Walking speed is assessed using the iSen Inertial Motion Capture System by STT Systems (iSEN IMUs )during the walking test and it is expressed in meters per second (m/s).

    Time frame: Baseline and post-intervention at Week 6

  6. Gait - Spatiotemporal: Gait Cadence

    Gait cadence is assessed using the iSen IMUs and it represents the average number of steps taken per minute during walking.

    Time frame: Baseline and post-intervention at Week 6

  7. Gait - Spatiotemporal: Step Length and Stride Length During Gait

    Step length and stride length are assessed using the iSEN IMU system during walking, expressed in meters (m). Step length represents the average distance between consecutive foot contacts of opposite feet and stride length represents the average distance between successive contacts of the same foot.

    Time frame: Baseline and post-intervention at Week 6

  8. Pelvic Symmetry

    Pelvic symmetry during gait is assessed using the iSEN IMUs and it is expressed as a percentage (%).

    Time frame: Baseline and post-intervention at Week 6

  9. Gait: Stance and Swing Phase Duration

    During Gait Stance and swing phase durations are assessed bilaterally using the iSEN IMUs. Stance phase represents the portion of the gait cycle during which the foot is in contact with the ground, and swing phase represents the portion during which the foot is not in contact with the ground. Values are recorded separately for the right and left limbs, expressed in seconds and as a percentage of the gait cycle.

    Time frame: Baseline and post-intervention at Week 6

  10. Gait: Double Support Duration During Gait

    Double support duration is assessed bilaterally using iSEN IMUs and represents the portion of the gait cycle during which both feet are concurrently in contact with the ground. Values are recorded separately for the right and left limbs, expressed as a percentage of the gait cycle.

    Time frame: Baseline and post-intervention at Week 6

  11. Gait Kinematics: Hip Flexion-Extension Angle During Gait

    Hip flexion and extension angles during the gait cycle are assessed bilaterally using the iSEN IMUs and expressed in degrees (º). Maximum hip flexion angle and minimum hip extension angle are recorded separately for the right and left limbs.

    Time frame: Baseline and post-intervention at Week 6

  12. Gait Kinematics: Hip Flexion-Extension Range of Motion During Gait

    Hip flexion-extension range of motion during the gait cycle is assessed bilaterally using the iSEN IMUs and expressed in degrees (º),it is recorded separately for the right and left limbs.

    Time frame: Baseline and post-intervention at Week 6

  13. Gait Kinematics: Knee Flexion-Extension Angle During Gait

    Knee flexion and extension angles during the gait cycle are assessed bilaterally using the iSEN IMUs and expressed in degrees (º). Maximum knee flexion angle and minimum knee extension angle are recorded separately for the right and left limbs.

    Time frame: Baseline and post-intervention at Week 6

  14. Gait Kinematics: Knee Flexion-Extension Range of Motion During Gait

    Knee flexion-extension range of motion during the gait cycle is assessed bilaterally using the iSEN IMUs and expressed in degrees (º), recorded separately for the right and left limbs.

    Time frame: Baseline and post-intervention at Week 6

  15. Gait Kinematics: Ankle Dorsiflexion-Plantarflexion Angle During Gait

    Ankle dorsiflexion and plantarflexion angles during the gait cycle are assessed bilaterally using the iSEN IMUs and expressed in degrees (º). Maximum dorsiflexion angle and minimum plantarflexion angle are recorded separately for the right and left limbs.

    Time frame: Baseline and post-intervention at Week 6

  16. Gait Kinematics: Ankle Dorsiflexion-Plantarflexion Range of Motion During Gait

    Ankle dorsiflexion-plantarflexion range of motion during the gait cycle is assessed bilaterally using the iSEN IMUs system and expressed in degrees (º), it is recorded separately for the right and left limbs.

    Time frame: Baseline and post-intervention at Week 6

  17. Gait Kinematics: Pelvic Tilt Angle During Gait

    Maximum posterior and anterior pelvic tilt angles during the gait cycle are assessed using the iSEN IMUs inertial measurement unit system and expressed in degrees (º), recorded separately as posterior tilt and anterior tilt values.

    Time frame: Baseline and post-intervention at Week 6

  18. Gait Kinematics: Pelvic Tilt Range of Motion

    Pelvic tilt range of motion during the gait cycle is assessed using the iSEN IMUs , representing the combined anterior (posterior tilt) and interior (anterior tilt) excursion, expressed in degrees (º).

    Time frame: Baseline and post-intervention at Week 6

Secondary outcomes

  1. Muscle Strength: Isometric Knee Extensor Muscle Strength

    Knee Extension Isometric Strength Assessment: Participants will sit with knees at \~90° flexion, feet unsupported, distal posterior thigh positioned \~10 cm from the chair's front edge, arms on the armrests with hands gripping the handles, and thighs/pelvis stabilized with a strap. A dynamometer will be fixed to an apparatus mounted behind the chair using a rigid, non-stretch strap positioned \~2 cm proximal to the lateral malleolus and secured across the anterior tibial surface; participants will perform knee extension, applying maximal isometric force against the dynamometer through the strap. Three 5-second maximal contractions will be performed, with 1-minute rest between trials and verbal encouragement to ensure maximal effort; peak force will be recorded for each trial.

    Time frame: Baseline and post-intervention at Week 6

  2. Muscle Strength: Isometric Knee Flexor Muscle Strength

    Knee Flexion Isometric Strength Assessment: Participants will sit with feet unsupported, arms on the armrests with hands gripping the handles, and popliteal fossa positioned \~10 cm anterior to the chair's front edge, with thighs/pelvis stabilized using a strap. A dynamometer will be fixed to an apparatus mounted in front of the chair using a rigid, non-stretch strap positioned \~2 cm proximal to the lateral malleolus and secured across the posterior tibial surface; participants will flex the knee to 90° and apply maximal isometric force against the dynamometer through the strap. Three 5-second maximal contractions will be performed, with 1-minute rest between trials and verbal encouragement to ensure maximal effort; peak force will be recorded for each trial.

    Time frame: Baseline and post-intervention at Week 6

  3. Trunk Muscle Endurance: Trunk Flexor Endurance

    Trunk flexor endurance is assessed using a 1-minute curl-up test. Participants perform repeated curl-ups from a supine position with knees flexed at 90°, sliding their hands forward toward the knees and returning to the starting position with proper form. The number of correctly completed repetitions within 1 minute is recorded.

    Time frame: Baseline and post-intervention at Week 6

  4. Trunk Extensor Endurance

    Description: Trunk extensor endurance is assessed using a modified Sørensen test performed on a Roman chair, with the pelvis and lower extremities secured. Participants cross their arms over the chest and maintain the trunk horizontally aligned with the lower extremities, knees extended, for as long as possible. The test is terminated when the participant can no longer sustain the position, and the duration is recorded in seconds.

    Time frame: Baseline and post-intervention at Week 6

07

Study locations

1 site
  • Türkan Sabancı Görme Engelliler Okulu
    Istanbul, Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be made available to other researchers. Because the study population consists of children, data sharing is restricted in line with the permission obtained from the Provincial Directorate of National Education. Study results will only be presented in aggregate form, without any information that could identify individual participants.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07789691
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Feb 14, 2025
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 25, 2026 (estimated)
Last update
Sep 2, 2026

Study contacts

Selda Uzun, PhD
principal investigator · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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