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

NCT07789691 | Active Not Recruiting

• 1 other identifier: MARMARA-VI-RP-2026-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Impairments

Keywords

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

Outcome Measures

Primary Outcomes (18)

• 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.

  Baseline and post-intervention at Week 6

• 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).

  Baseline and post-intervention at Week 6

• 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).

  Baseline and post-intervention at Week 6

• 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).

  Baseline and post-intervention at Week 6

• Gait - Spatiotemporal:Walking Speed

  Walking speed is assessed using the STT-WS inertial measurement unit system during the walking test and it is expressed in meters per second (m/s).

  Baseline and post-intervention at Week 6

• Gait - Spatiotemporal: Gait Cadence

  Gait cadence is assessed using the STT-WS system and it represents the average number of steps taken per minute during walking.

  Baseline and post-intervention at Week 6

• Gait - Spatiotemporal: Step Length and Stride Length During Gait

  Step length and stride length are assessed using the STT-WS inertial measurement unit 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.

  Baseline and post-intervention at Week 6

• Pelvic Symmetry

  Pelvic symmetry during gait is assessed using the STT-WS system and it is expressed as a percentage (%).

  Baseline and post-intervention at Week 6

• Gait: Stance and Swing Phase Duration

  During Gait Stance and swing phase durations are assessed bilaterally using the STT-WS system. 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.

  Baseline and post-intervention at Week 6

• Gait: Double Support Duration During Gait

  Double support duration is assessed bilaterally using the STT-WS system 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.

  Baseline and post-intervention at Week 6

• Gait Kinematics: Hip Flexion-Extension Angle During Gait

  Hip flexion and extension angles during the gait cycle are assessed bilaterally using the STT-WS inertial measurement unit system and expressed in degrees (º). Maximum hip flexion angle and minimum hip extension angle are recorded separately for the right and left limbs.

  Baseline and post-intervention at Week 6

• 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 STT-WS system and expressed in degrees (º),it is recorded separately for the right and left limbs.

  Baseline and post-intervention at Week 6

• Gait Kinematics: Knee Flexion-Extension Angle During Gait

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

  Baseline and post-intervention at Week 6

• 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 STT-WS system and expressed in degrees (º), recorded separately for the right and left limbs.

  Baseline and post-intervention at Week 6

• Gait Kinematics: Ankle Dorsiflexion-Plantarflexion Angle During Gait

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

  Baseline and post-intervention at Week 6

• 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 STT-WS system and expressed in degrees (º), it is recorded separately for the right and left limbs.

  Baseline and post-intervention at Week 6

• Gait Kinematics: Pelvic Tilt Angle During Gait

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

  Baseline and post-intervention at Week 6

• Gait Kinematics: Pelvic Tilt Range of Motion

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

  Baseline and post-intervention at Week 6

Secondary Outcomes (4)

• Muscle Strength: Isometric Knee Extensor Muscle Strength

  Baseline and post-intervention at Week 6

• Muscle Strength: Isometric Knee Flexor Muscle Strength

  Baseline and post-intervention at Week 6

• Trunk Muscle Endurance: Trunk Extensor Endurance

  Baseline and post-intervention at Week 6

• Trunk Extensor Endurance

  Baseline and post-intervention at Week 6

Study Arms (3)

Pilates (Equipment-Based Pilates(Reformer)) Group

EXPERIMENTAL

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)

Vestibular Exercise Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Equipment-Based Pilates Exercise (Reformer) BEHAVIORAL

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.

Pilates (Equipment-Based Pilates(Reformer)) Group

Vestibular Exercise Program BEHAVIORAL

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.

Vestibular Exercise Group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Türkan Sabancı Görme Engelliler Okulu

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selda Uzun, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: February 14, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)