Türkan Sabancı Görme Engelliler Okulu
Istanbul, Turkey (Türkiye)
NCT Number: NCT07789691
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.
This study is active but is not currently recruiting participants.
Notify Me10 year–17 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline and post-intervention at Week 6
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Marmara University
Other
Effects of Different Exercise Programs on Balance Performance and Gait Biomechanics in Children With Visual Impairment
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