Cervical Vertebrae InjuryRVZUNCT06089915
Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI
A study testing Standard occupational therapy and Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton in people with Cervical Vertebrae Injury, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Vertebrae Injury
- What is being tested?
- Standard occupational therapy and Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
Urška Kidrič Sivec, MD, MSc, +386 1 4758438, urska.kidric@ir-rs.si
Tibor Kafel, OT
About this study
Official title: Assessing Effectiveness of Robot-assisted Upper-limb Exercise in Persons After Cervical Spinal Cord Injury
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.
Read the 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.
- Conditions
- Cervical Vertebrae Injury
- Being tested
- Standard occupational therapy, Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton
- Keywords
- spinal cord injury, upper limbs, impairment, rehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard occupational therapyBehavioural
Standard occupational therapy as part of inpatient rehabilitation
Robot-assisted exercise using Amadeo device and Armeo Spring exoskeletonDevice
Exercise for fingers and hand using Amadeo device plus gross-motor exercise using Armeo Spring exoskeleton
| Study group | Role | What they receive |
|---|---|---|
| Occupational therapy + robot-assisted exercise | Experimental | 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 Receives: Behavioral: Standard occupational therapy; Device: Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton |
| Occupational therapy only | Active comparator | Standard occupational therapy five times per week for 90 minutes (tailored to the patient's needs and abilities) Receives: Behavioral: Standard occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Before intervention (at admission) and after the intervention (on average after 3 weeks)
Secondary outcomes (2)
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
Measured: 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
Measured: Before intervention (at admission) and after the intervention (on average after 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Vertebrae InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tibor Kafel, OT, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089915
- Sponsor's protocol ID
- URIS202301
- Acronym
- RVZU
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Effectiveness of Robot-assisted Upper-limb Exercise in Persons After Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06089915
- Acronym / sponsor ID
- RVZU / URIS202301
- Conditions
- Cervical Vertebrae Injury
- Keywords
- spinal cord injury, upper limbs, impairment, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy + robot-assisted exercise | Experimental | Behavioral: Standard occupational therapy, Device: Robot-assisted exercise using Amadeo device and Armeo Spring exoskeletonStandard 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 |
| Occupational therapy only | Active comparator | Behavioral: Standard occupational therapyStandard occupational therapy five times per week for 90 minutes (tailored to the patient's needs and abilities) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard occupational therapyStandard occupational therapy as part of inpatient rehabilitation | Behavioural | Occupational therapy + robot-assisted exercise, Occupational therapy only |
| Robot-assisted exercise using Amadeo device and Armeo Spring exoskeletonExercise for fingers and hand using Amadeo device plus gross-motor exercise using Armeo Spring exoskeleton | Device | Occupational therapy + robot-assisted exercise |
Primary outcome
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)
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
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)
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
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tibor Kafel, OT principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard occupational therapy and Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton in people with Cervical Vertebrae Injury, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Metka Moharić, MD, PhD (+386 1 4758441, metka.moharic@ir-rs.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.