Health TrialsbyHealthPanel

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

ConditionCervical Vertebrae Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Rehabilitation Institute, Republic of Slovenia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Standard occupational therapy

    Behavioral

    Standard occupational therapy as part of inpatient rehabilitation

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Occupational therapy + robot-assisted exerciseExperimental treatment 2 interventions
Group B: Occupational therapy onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Before intervention (at admission) and after the intervention (on average after 3 weeks)
2

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

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

Secondary outcomes

1

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

Time frame
Before intervention (at admission) and after the intervention (on average after 3 weeks)
2

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Rehabilitation Institute, Republic of Slovenia

Lead sponsor

Source ClinicalTrials.gov
Apply now