Effects of Different Exercise Programs on Balance Performance and Gait Biomechanics in Children With Visual Impairment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Static Balance Performance: Center of Pressure Sway Area
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Vestibular Exercise Program (Behavioral)
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.
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
干预措施: Equipment-Based Pilates Exercise (Reformer) (Behavioral)
结局指标
主要结局
Static Balance Performance: Center of Pressure Sway Area
时间窗: 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.
Static Balance Performance: Center of Pressure Path Length
时间窗: 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).
Static Balance Performance: Antero-posterior Center of Pressure Excursion
时间窗: 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).
Static Balance Performance: Mediolateral Center of Pressure Excursion
时间窗: 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).
Gait - Spatiotemporal:Walking Speed
时间窗: 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).
Gait - Spatiotemporal: Gait Cadence
时间窗: 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.
Gait - Spatiotemporal: Step Length and Stride Length During Gait
时间窗: 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.
Pelvic Symmetry
时间窗: Baseline and post-intervention at Week 6
Pelvic symmetry during gait is assessed using the iSEN IMUs and it is expressed as a percentage (%).
Gait: Stance and Swing Phase Duration
时间窗: 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.
Gait: Double Support Duration During Gait
时间窗: 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.
Gait Kinematics: Hip Flexion-Extension Angle During Gait
时间窗: 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.
Gait Kinematics: Hip Flexion-Extension Range of Motion During Gait
时间窗: 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.
Gait Kinematics: Knee Flexion-Extension Angle During Gait
时间窗: 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.
Gait Kinematics: Knee Flexion-Extension Range of Motion During Gait
时间窗: 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.
Gait Kinematics: Ankle Dorsiflexion-Plantarflexion Angle During Gait
时间窗: 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.
Gait Kinematics: Ankle Dorsiflexion-Plantarflexion Range of Motion During Gait
时间窗: 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.
Gait Kinematics: Pelvic Tilt Angle During Gait
时间窗: 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.
Gait Kinematics: Pelvic Tilt Range of Motion
时间窗: 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).
次要结局
- Trunk Muscle Endurance: Trunk Extensor Endurance(Baseline and post-intervention at Week 6)
- 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 Flexor Endurance(Baseline and post-intervention at Week 6)
- Trunk Extensor Endurance(Baseline and post-intervention at Week 6)