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Visual ImpairmentsNCT07789691

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

A study testing Equipment-Based Pilates Exercise (Reformer) and Vestibular Exercise Program in people with Visual Impairments, run by Marmara University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Visual Impairments
What is being tested?
Equipment-Based Pilates Exercise (Reformer) and Vestibular Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Feb 2025to 25 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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

    Istanbul, Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Different Exercise Programs on Balance Performance and Gait Biomechanics in Children With Visual Impairment

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.

Read more

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.

Being tested
Equipment-Based Pilates Exercise (Reformer), Vestibular Exercise Program
Keywords
Pilates (Equipment-Based Pilates), Vestibular Exercise, Balance Performance, Gait Biomechanics, Muscle Strength, Children, Adolescents
Medical subject headings
Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Equipment-Based Pilates Exercise (Reformer)Behavioural

    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.

  • Vestibular Exercise ProgramBehavioural

    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.

Study groups in NCT07789691
Study groupRoleWhat they receive
Pilates (Equipment-Based Pilates(Reformer)) GroupExperimentalParticipants in this arm received a supervised Reformer Pilates exercise program twice weekly for 6 weeks, for a total of 12 sessions
Receives: Behavioral: Equipment-Based Pilates Exercise (Reformer)
Vestibular Exercise GroupExperimentalParticipants in this group receive a supervised vestibular balance exercise program for 6 weeks, consisting of 12 sessions (two sessions per week).
Receives: Behavioral: Vestibular Exercise Program
Control GroupNo interventionParticipants in this arm continued their usual daily activities and did not receive either of the study exercise programs during the study period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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 (%).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: Baseline and post-intervention at Week 6

Secondary outcomes (4)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and post-intervention at Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start14 Feb 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion25 Dec 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07789691
Sponsor's protocol ID
MARMARA-VI-RP-2026-01
Status last verified
Aug 2026
First submitted
24 Aug 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Equipment-Based Pilates Exercise (Reformer) and Vestibular Exercise Program in people with Visual Impairments, run by Marmara University at 1 site in Turkey (Türkiye).

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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

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?

Static Balance Performance: Center of Pressure Sway Area (time frame: Baseline and post-intervention at Week 6). The study lists 18 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 2 Sep 2026.

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