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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Cervical Vertebrae Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Standard occupational therapy

Intervention Type BEHAVIORAL

Standard occupational therapy as part of inpatient rehabilitation

Robot-assisted exercise using Amadeo device and Armeo Spring exoskeleton

Intervention Type DEVICE

Exercise for fingers and hand using Amadeo device plus gross-motor exercise using Armeo Spring exoskeleton

Occupational therapy only

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

Group Type ACTIVE_COMPARATOR

Standard occupational therapy

Intervention Type BEHAVIORAL

Standard occupational therapy as part of inpatient rehabilitation

Interventions

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Standard occupational therapy

Standard occupational therapy as part of inpatient rehabilitation

Intervention Type BEHAVIORAL

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No