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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Vertebrae Injury
• Intervention / Treatment: Behavioral: Standard occupational therapy; Device: Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Metka Moharić, MD, PhD; Phone Number: +386 1 4758441; Email: metka.moharic@ir-rs.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • University Rehabilitation Institute, Republic of Slovenia
    • Contact: Urška Kidrič Sivec, MD, MSc; Phone Number: +386 1 4758438; Email: urska.kidric@ir-rs.si
    • Principal Investigator: Tibor Kafel, OT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Occupational therapy + robot-assisted exercise; 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	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
Active Comparator: Occupational therapy only; Standard occupational therapy five times per week for 90 minutes (tailored to the patient's needs and abilities)	Behavioral: Standard occupational therapy; Standard occupational therapy as part of inpatient rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Before intervention (at admission) and after the intervention (on average after 3 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Before intervention (at admission) and after the intervention (on average after 3 weeks)

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia
• Investigators: Principal Investigator: Tibor Kafel, OT, University Rehabilitation Institute, Republic of Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; spinal cord injury; impairment; upper limbs
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: URIS202301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No