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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing Effectiveness of Robot-assisted Upper-limb Exercise in Persons After Cervical Spinal Cord Injury

Conditions
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Cervical Vertebrae Injury

Intervention / Treatment
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* Behavioral: Standard occupational therapy
* Device: Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occupational therapy + robot-assisted exercise<br>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<br>* Standard occupational therapy as part of inpatient rehabilitation<br>Device: Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton<br>* Exercise for fingers and hand using Amadeo device plus gross-motor exercise using Armeo Spring exoskeleton<br>|
| Active Comparator: Occupational therapy only<br>Standard occupational therapy five times per week for 90 minutes (tailored to the patient's needs and abilities) | Behavioral: Standard occupational therapy<br>* Standard occupational therapy as part of inpatient rehabilitation<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, upper limbs, impairment, rehabilitation