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NCT Number: NCT06089915

Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI

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.

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Key information

Conditions

Cervical Vertebrae Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Tibor Kafel, OT

PRINCIPAL_INVESTIGATOR

Urška Kidrič Sivec, MD, MSc

CONTACT

[email protected]

+386 1 4758438

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Occupational Therapy

Behavioral

Standard occupational therapy as part of inpatient rehabilitation

Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton

Device

Exercise for fingers and hand using Amadeo device plus gross-motor exercise using Armeo Spring exoskeleton

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Difference in Spinal Cord Independence Measure (SCIM) score

    Time frame: Before intervention (at admission) and after the intervention (on average after 3 weeks)

    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

  2. Difference in Canadian Occupational Performance Measure (COPM) results

    Time frame: Before intervention (at admission) and after the intervention (on average after 3 weeks)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Metka Moharić, MD, PhD

CONTACT

[email protected]

+386 1 4758441

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Registry information

Official study title

Assessing Effectiveness of Robot-assisted Upper-limb Exercise in Persons After Cervical Spinal Cord Injury

Acronym: RVZU

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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