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

NCT06089915 | Recruiting

• 1 other identifier: URIS202301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Vertebrae Injury

Keywords

spinal cord injury; upper limbs; impairment; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Difference in Spinal Cord Independence Measure (SCIM) score

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

• Difference in Canadian Occupational Performance Measure (COPM) results

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

Study Arms (2)

Occupational therapy + robot-assisted exercise

EXPERIMENTAL

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

Occupational therapy only

ACTIVE COMPARATOR

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

Behavioral: Standard occupational therapy

Interventions

Standard occupational therapy BEHAVIORAL

Standard occupational therapy as part of inpatient rehabilitation

Occupational therapy + robot-assisted exercise; Occupational therapy only

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

Occupational therapy + robot-assisted exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Tibor Kafel, OT

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Metka Moharić, MD, PhD

CONTACT

+386 1 4758441; metka.moharic@ir-rs.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 19, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)