NCT06089915

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Rehabilitation Institute, Republic of Slovenia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Cervical Vertebrae Injury

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-10-19
• Last updated: 2025-03-25

Locations

1 site across 1 country: Slovenia