Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI (RVZU)

University Rehabilitation Institute, Republic of Slovenia

Status: Enrolling

Conditions: Cervical Vertebrae Injury

Treatments: Device: Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton; Behavioral: Standard occupational therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06089915

URIS202301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Occupational therapy + robot-assisted exercise

Experimental group

Description:

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

Treatment:

Behavioral: Standard occupational therapy

Device: Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton

Occupational therapy only

Active Comparator group

Description:

Standard occupational therapy five times per week for 90 minutes (tailored to the patient's needs and abilities)

Treatment:

Behavioral: Standard occupational therapy