The study aims to evaluate the effects of robotic-assisted gait training (Lokomat) on dynamic postural stability in patients with incomplete spinal cord injury (SCI). Participants will be randomized into two groups: one receiving robotic training and another receiving conventional postural stability exercises. The primary evaluation will use the Mini-BESTest, supplemented by objective gait analysis using wearable inertial sensors (IMUs) to measure symmetry, fluidity, and stability. A secondary objective is to compare these gait indices between SCI patients and healthy individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
It is a robotic rehabilitation with Lokomat training.
Conventional rehabilitation (Physiotherapy)
Santa Lucia Foundation, Scientific Institute for Research and Health Care
Roma, RM, Italy
Mini-Balance Evaluation Systems Test (Mini-BESTest) Score
Assessment of dynamic balance across 14 tasks (Score range: 0-28, with higher scores indicating better balance performance and lower fall risk).
Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
Berg Balance Scale (BBS)
Static and dynamic balance assessment (Score range: 0-56, with higher scores indicating better balance performance and lower fall risk).
Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
Dynamic Gait Index (DGI)
Ability to modify gait in response to task demands (Score range: 0-24, with higher scores indicating better balance performance and lower fall risk).
Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
Inertial Measurement Unit (IMU)-derived Gait Parameters
Quantitative measures spatiotemporal gait parameters
Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
IMU-derived Gait Parameters - Root Mean Square
Quantitative measures of dynamic postural stability (Root Mean Square)
Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
IMU-derived Gait Parameters -Improved Harmonic Ratio
Quantitative measures of simmetry of gait (Improved Harmonic Ratio)
Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
IMU-derived Gait Parameters -log dimensionless jerk
Quantitative measures of smoothness of gait (log dimensionless jerk)
Time frame: Baseline (prior to the first intervention session) and 4 weeks post-baseline (after 12 intervention sessions).
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