An interventional study of Standard occupational therapy and Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton in Cervical Vertebrae Injury, sponsored by University Rehabilitation Institute, Republic of Slovenia. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by University Rehabilitation Institute, Republic of Slovenia · Not applicable, Interventional, and Treatment
The aim of the project is to test the effectiveness of robot-assisted upper-limb exercise in persons after cervical spinal cord injury. In a randomised controlled two-arm trial, the effect of adding two types of robot-assisted upper-limb exercise to standard occupational therapy will be tested. Three primary and two secondary outcomes will be assessed using well-established measures.
Unlike for persons after stroke, there is no high-quality evidence of the effectiveness of robot-assisted upper-limb exercise in persons after cervical spinal cord injury. For this reason, we are aiming to conduct a randomised trial. The trial will involve two groups of adult patients admitted to inpatient rehabilitation. One group will receive standard occupational therapy, tailored to the patient's needs and abilities, five times per week for 90 minutes. In addition to the standard occupational therapy, the other group will receive ten 30-minute session of robot-assisted exercise: five sessions of exercise for fingers and hand using a specialised device, and five sessions of gross-motor exercise using an exoskeleton. Three outcome measures will be used to comprehensively assess the patients at the beginning and at the end of the intervention, i.e., upon admission and discharge: the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP; general and Myelopathy version), the Spinal Cord Independence Measure (SCIM), and the Canadian Occupational Performance Measure (COPM). The progress in those measures will be compared between the two groups.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 30 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University Rehabilitation Institute, Republic of Slovenia is the lead sponsor of 21 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Standard occupational therapy five times per week for 90 minutes (tailored to the patient's needs and abilities) + five 30' sessions (2-3 per week) of robot-assisted exercise for fingers and hand using Amadeo device + five 30' sessions (2-3 per week) of robot-assisted exercise using Armeo Spring exoskeleton for facilitating gross movements of upper limbs
Behavioral: Standard occupational therapy · Device: Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton
Standard occupational therapy five times per week for 90 minutes (tailored to the patient's needs and abilities)
Behavioral: Standard occupational therapy
Standard occupational therapy as part of inpatient rehabilitation
Exercise for fingers and hand using Amadeo device plus gross-motor exercise using Armeo Spring exoskeleton
Difference in Graded Redefined Assessment of Strength, Sensibility and Prehension Version 2 (GRASSP V2) score
Clinical impairment measure specific to the upper limb for use after tetraplegia that measures sensorimotor and prehension function through three domains; total score for each body side ranges from 0 to 94; higher scores mean a better outcome
Time frame: Before intervention (at admission) and after the intervention (on average after 3 weeks)
Difference in Graded Redefined Assessment of Strength, Sensibility and Prehension - Mielopathy (GRASSP-M) score
Objective tool designed to characterize patients' functional impairment related to the upper limb, useful for diagnosing and quantifying mild dysfunction and monitoring patients for deterioration; total score for each body side ranges from 0 to 74; higher scores mean a better outcome
Time frame: Before intervention (at admission) and after the intervention (on average after 3 weeks)
Difference in Spinal Cord Independence Measure (SCIM) score
Assessement of performance in activities of daily living and mobility for individuals with spinal cord injury; score ranges from 0 to 100; higher scores mean a better outcome
Time frame: Before intervention (at admission) and after the intervention (on average after 3 weeks)
Difference in Canadian Occupational Performance Measure (COPM) results
Individualized, client-centred outcome measure designed to capture a client's self-perception of performance in everyday living, over time; performance and satisfaction scores range from 1 to 10; higher scores mean a better outcome
Time frame: Before intervention (at admission) and after the intervention (on average after 3 weeks)
Plan to share: No
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Started Sep 2023 (actual). Primary completion is estimated for Dec 2026, 39 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 39 months is close to that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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University Rehabilitation Institute, Republic of Slovenia