Exploratory study on the effect of Rimonabant on hand function in patients with spinal cord injury (RIMOHANDOPEN)

简要总结

主要结局

次要结局

• Visual Analogue Scale for Fatigue (VAS-F): assesses perceived fatigue intensity by having participants rate their level of fatigue after FTT
• 6-Minute Walk Test (6MWT): measures the distance a participant can walk in six minutes, providing an index to measure fatigue, endurance and functional walking capacity
• 10-Meter Walk Test (10MWT): measures the time taken to walk 10 meters at a comfortable or maximal pace, used to assess motor function through walking speed, fatigue and endurance
• Berg Balance Scale (BBS): evaluates static and dynamic balance through 14 functional tasks, providing a quantitative assessment of fall risk and postural control
• Walking Index for Spinal Cord Injury II (WISCI-II): assesses walking ability based on the level of assistance, use of assistive devices and need for support, yielding a score reflecting functional ambulation capacity.
• Finger Tapping Test (FTT): measures motor speed and coordination by recording the number of finger taps within a set time period
• Box and Block Test (BBT): assesses gross manual dexterity by counting the number of blocks transferred from one compartment to another in 60 seconds
• Nine-Hole Peg Test (9HPT): measures fine manual dexterity by timing how long it takes to place and remove nine pegs from a boardNine-Hole Peg Test (9HPT): measures fine manual dexterity by timing how long it takes to place and remove nine pegs from a board
• Dynamometry: measures handgrip strength by recording the maximum force exerted during a grip using a handheld dynamometer.
• Upper Extremity Motor Score (UEMS): evaluates motor strength of five key upper limb muscles bilaterally. This data is obtained from the ISNCSCI scale
• Functional Reach Test (FRT): assesses upper limb functional reach and dynamic balance by measuring the maximum distance an individual can reach forward without losing stability
• Borg CR10 Scale: assesses perceived exertional fatigue immediately after the 6MWT and FTT, providing a subjective measure of effort intensity
• Fatigue Severity Scale (FSS): evaluates fatigue severity over the previous week. Scores ≥ 4 indicate clinically significant fatigue
• Multidimensional Fatigue Inventory (MFI-20): measures five dimensions of fatigue, offering a comprehensive assessment of fatigue impact
• Breathing test: test designed to evaluate the respiratory function and lung capacity of the participant.
• Oximetry: non-invasively measures blood oxygen saturation and heart rate, providing a quick indicator of the participant's respiratory status
• Heart rate: non-invasive measurement used to monitor cardiovascular response and detect potential abnormalities in heart function.
• Blood pressure (systolic and diastolic): non-invasive assessment providing key information on vascular resistance and overall cardiovascular health.
• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI): determines the neurological level and completeness of spinal cord injury through systematic assessment of motor and sensory function
• Transcranial magnetic stimulation (TMS): evaluate corticospinal excitability and motor pathway integrity registering motor evoked potentials (MEPs).
• Somatosensory evoked potentials (SEPs) via electrical stimulation: assess sensory pathway conduction and integrity by recording cortical responses to peripheral nerve electrical stimulation.
• Spinal Cord Independence Measure (SCIM-III): measures functional independence in activities of daily living, mobility, and sphincter management, providing an index of overall functional recovery.
• Medical Outcomes Study Sleep Scale (MOS-SS): assesses multiple aspects of sleep, including quality, disturbances, somnolence, and adequacy, over the previous four weeks.
• Patient Global Impression of Change (PGIC): captures the patient’s subjective perception of overall improvement or deterioration since the beginning of the study.
• Recording and assessment of adverse events (AEs) occurring during treatment, serious adverse events (SAEs), and adverse events of special interest (AESIs).
• Clinically significant changes in physical examination, biochemical parameters, vital signs.
• Clinically significant changes in subjective pain perception, assessed using the Visual Analogue Scale (VAS-P).
• Clinically significant changes in the level of muscle spasticity, assessed using the Modified Ashworth Scale (MAS).
• Clinically significant changes in the frequency of muscle spasms, assessed using the Penn Spasm Frequency Scale (PSFS).
• Clinically significant changes in mood, specifically depression and anxiety, assessed using the Beck Depression Inventory-II (BDI-II) and the Hospital Anxiety and Depression Scale (HADS).
• Suicide risk, assessed using C-SSRS.