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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07789691
Enrollment
75
Registered
2026-08-27
Start date
2025-02-14
Completion date
2026-12-25
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Impairments

Keywords

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

Brief 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.

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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

The two research assistants performing outcome measurements were unaware of participants' intervention/control group allocation; however, the principal investigator's involvement, despite being aware of allocation, rendered the study effectively open-label.

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* 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

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

Design outcomes

Primary

MeasureTime frameDescription
Gait - Spatiotemporal: Gait CadenceBaseline and post-intervention at Week 6Gait cadence is assessed using the iSen IMUs and it represents the average number of steps taken per minute during walking.
Gait - Spatiotemporal: Step Length and Stride Length During GaitBaseline and post-intervention at Week 6Step 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.
Pelvic SymmetryBaseline and post-intervention at Week 6Pelvic symmetry during gait is assessed using the iSEN IMUs and it is expressed as a percentage (%).
Gait: Stance and Swing Phase DurationBaseline and post-intervention at Week 6During 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.
Gait: Double Support Duration During GaitBaseline and post-intervention at Week 6Double 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.
Gait Kinematics: Hip Flexion-Extension Angle During GaitBaseline and post-intervention at Week 6Hip 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.
Gait Kinematics: Hip Flexion-Extension Range of Motion During GaitBaseline and post-intervention at Week 6Hip 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.
Gait Kinematics: Knee Flexion-Extension Angle During GaitBaseline and post-intervention at Week 6Knee 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.
Gait Kinematics: Knee Flexion-Extension Range of Motion During GaitBaseline and post-intervention at Week 6Knee 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.
Gait - Spatiotemporal:Walking SpeedBaseline and post-intervention at Week 6Walking 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).
Static Balance Performance: Center of Pressure Sway AreaBaseline and post-intervention at Week 6Center 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.
Static Balance Performance: Center of Pressure Path LengthBaseline and post-intervention at Week 6Center 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).
Static Balance Performance: Antero-posterior Center of Pressure ExcursionBaseline and post-intervention at Week 6Anteroposterior 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).
Static Balance Performance: Mediolateral Center of Pressure ExcursionBaseline and post-intervention at Week 6Medio-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).
Gait Kinematics: Ankle Dorsiflexion-Plantarflexion Angle During GaitBaseline and post-intervention at Week 6Ankle 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.
Gait Kinematics: Ankle Dorsiflexion-Plantarflexion Range of Motion During GaitBaseline and post-intervention at Week 6Ankle 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.
Gait Kinematics: Pelvic Tilt Angle During GaitBaseline and post-intervention at Week 6Maximum 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.
Gait Kinematics: Pelvic Tilt Range of MotionBaseline and post-intervention at Week 6Pelvic 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).

Secondary

MeasureTime frameDescription
Muscle Strength: Isometric Knee Extensor Muscle StrengthBaseline and post-intervention at Week 6Knee 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.
Muscle Strength: Isometric Knee Flexor Muscle StrengthBaseline and post-intervention at Week 6Knee 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.
Trunk Muscle Endurance: Trunk Flexor EnduranceBaseline and post-intervention at Week 6Trunk 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.
Trunk Extensor EnduranceBaseline and post-intervention at Week 6Description: 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORSelda Uzun, PhD

Marmara University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026