Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard occupational therapy, Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton.
- Who it may be relevant to
- Registry conditions: Cervical Vertebrae Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing Effectiveness of Robot-assisted Upper-limb Exercise in Persons After Cervical Spinal Cord Injury
Overview
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.
Detailed description
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.
Interventions
- Behavioral Standard occupational therapy
Standard occupational therapy as part of inpatient rehabilitation - Device Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton
Exercise for fingers and hand using Amadeo device plus gross-motor exercise using Armeo Spring exoskeleton
Primary outcome measures
- Difference in Graded Redefined Assessment of Strength, Sensibility and Prehension Version 2 (GRASSP V2) score [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 [Time frame: Before intervention (at admission) and after the intervention (on average after 3 weeks)]
Secondary outcome measures (2)
- Difference in Spinal Cord Independence Measure (SCIM) score [Time frame: Before intervention (at admission) and after the intervention (on average after 3 weeks)]
- Difference in Canadian Occupational Performance Measure (COPM) results [Time frame: Before intervention (at admission) and after the intervention (on average after 3 weeks)]
Eligibility criteria
Inclusion criteria
- ability to move unloaded upper limbs
- at least 18 years of age
- ability to sit for one hour
- ability to understand the instructions for robot-assisted exercise
Exclusion criteria
- inability to sit for one hour
- presence of hospital-acquired infection that requires isolation
- bodily impairment other than spinal cord injury
- inability to understand the instructions for robot-assisted exercise
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- University Rehabilitation Institute, Republic of Slovenia — Ljubljana
Identifiers
NCT: NCT06089915 · URIS202301