Patient-therapist INTERaction During RObotic GAIT Rehabilitation After Spinal Cord Injury
NCT Number: NCT06531304
Acronym: INTERROGAIT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injuries
Interventions: DEVICE: Lokomat Robot Assisted Gait Training
Sponsor: I.R.C.C.S. Fondazione Santa Lucia
Collaborators: University of Roma La Sapienza
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-05
Completion Date: 2025-05-31
Locations: I.R.C.C.S. Fondazione Santa Lucia, Roma, Rome, 00179, Italy

Summary:
INTERROGAIT will disentangle the role of Physical Therapist - Patient (Pht-Pt) interaction in robotic assisted gait rehabilitation in spinal cord injury patients. The study is structured as a single blind randomized controlled trial with two arms, in which effects of different Pht-Pt interaction levels will be assessed on the ongoing robotic treatment with the Lokomat device. The main hypothesis is that when Pht-Pt interaction is maximized (experimental group), this will allow to better rehabilitation outcome with respect to a minimun level of Pht-Pt interaction (control group).

Primary Outcome Measures: Changes in 10 Meters Walking Test (10MWT), Time test for gait speed assessment on short distance. The patients are instructed to walk a 10 meters distance, and the gait speed is calculated., Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)|Changes in Min Walking test (6MWT), Time test for gait speed assessment on long distance. The distance covered over a time of 6 minutes is recorded, and the gait speed is calculated, Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)
Secondary Outcome Measures: Changes in Walking Index for Spinal Cord Injury II (WISCI-II), WISCI-II assess the amount of physical assistance needed, as well as devices or orthosis required, for walking following iSCI. Scores range from 0 (inability to walk) and 20 (patient can walk with no assistance, no aids, no orthoses), Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)|Changes in Lower-extremity motor scores (LEMS) of American Spinal Cord Injury Association, The LEMS evaluates motor function on a scale that ranges from 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side). The key muscles of the lower limbs assessed for LEMS are: hip flexor muscles, knee extensor muscles, ankle dorsiflexor muscles, long toe extensors muscles, and ankle plantarflexor muscles., Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)|Changes in Modified Ashworth Scale (MAS), The MAS for spasticity assessment is a 6 points numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension., Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)|Changes in Independence in activities of daily living per the Spinal Cord Independence Measure III (SCIM-III), The SCIM-III is designed for individuals with SCI and assesses performance in activities of daily living and mobility. There are a total of 19 items, which are divided into 3 subscales (self-care, respiration and sphincter management, and mobility). A total score out of 100 is achieved, with the subscales weighted as follows: self-care: scored 0-20; respiration and sphincter management: scored 0-40; and mobility: scored 0-40. Scores are higher in patients that require less assistance or fewer aids to complete basic activities of daily living and life support activities., Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)
Other Outcome Measures: Changes in Patient EEG spectral activity and Pht-Pt inter-brain connectivity, High density Electroencephalography (hdEEG) signals will be recorded simultaneously (EEG hyperscanning) from Pt and Pht during their interaction. Changes in Pt patterns of cortical oscillatory activity and Pht-Pt inter-brain connectivity, as assessed during neurophysiological assessment before and after the intervention, will be investigated. The analysis will focus on spectral activations of specific brain regions and objective indices characterizing Pht-Pt multiple-brain connectivity patterns within motor related frequency band., Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)|Changes in Kinematic, Kinetic and Electromyography parameters, Kinematic, Kinetic and surface Electromyography parameters of the lower limbs will be recorded both during gait on a flat surface, to detect at least 5 gait cycles, with the Optitrack system for instrumental gait analysis., Within 24 h before starting RAGT intervention (Pre) and within 24 hours from the twelfth Lokomat session (Post)