Clinical trial NCT06089915: Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI
Official title: Assessing Effectiveness of Robot-assisted Upper-limb Exercise in Persons After Cervical Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Vertebrae Injury
Keywords: spinal cord injury
upper limbs
impairment
rehabilitation
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Difference in Graded Redefined Assessment of Strength, Sensibility and Prehension Version 2 (GRASSP V2) score
timeFrame: Before intervention (at admission) and after the intervention (on average after 3 weeks)
measure: Difference in Graded Redefined Assessment of Strength, Sensibility and Prehension - Mielopathy (GRASSP-M) score
timeFrame: Before intervention (at admission) and after the intervention (on average after 3 weeks)
Secondary outcomes:
measure: Difference in Spinal Cord Independence Measure (SCIM) score
timeFrame: Before intervention (at admission) and after the intervention (on average after 3 weeks)
measure: Difference in Canadian Occupational Performance Measure (COPM) results
timeFrame: Before intervention (at admission) and after the intervention (on average after 3 weeks)
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Tibor Kafel, OT
role: PRINCIPAL_INVESTIGATOR
References: