About this trial
The goal of this clinical trial is to learn the effects of robot-assisted therapy using the ArmeoSpring on upper limb function compared to conventional occupational therpay in individuals with cervical spinal cord injury (cSCI). The main questions it aims to answer are:
\- Which of the two forms of therapy, robot-assisted therapy or conventional occupational therapy, is more effective in terms of improving arm and hand function?
The study is designed as a cross-over trial, which means that each participant will receive both therapy forms consecutively, whereas the order is assigned randomly (either robot-assisted therapy first and then occupational therapy, or vice versa).
In addition to their clinical routine therapy , participants will:
* complete a baseline assessment * practice one therapy form (either robot-assisted or occupational therapy) with one arm for 6 weeks (3 x 30 min per week) * complete a intermediate assessment * practice the other therapy form (either occupational or robot-assisted therapy) with one arm for 6 weeks (3 x 30 min per week) * complete a post assessment * complete a follow-up assessment (if the post assessment was completed prior to 150 days post-injury)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed Consent signed by the subject
Intermediate (>16 days and ≤81 days post-injury) traumatic or non-traumatic cSCI during primary rehabilitation at the Swiss Paraplegic Centre (SPC)
Neurological level of injury: C1-T1
American Spinal Injury Association Impairment Scale (AIS): A-D
Disqualifiers
Inability to follow the procedures of the investigation
Severe concomitant neurological disease
Concomitant neurodegenerative or progressive diseases
Impairment of upper limb function due to peripheral nerve lesions
Trial design
Crossover
Treatments tested in this trial
Unilateral robot-assisted therapy (RT)
Other interventionRT will be performed as an add-on therapy to the clinical routine therapy scheme for 3 x 30 minutes per week for 6 weeks. RT is applied using the ArmeoSpring, an exoskeleton that provides adjustable antigravity weight support for the arm through a system of springs (no actuators).
Unilateral conventional occupational therapy (OT)
Other interventionThe OT is applied as add-on therapy for 3 x 30 minutes per week for 6 weeks. OT comprises strengthening exercises (concentric and eccentric) with and without resistance, grasping exercises, fine motor training, peg games, and activity-based tasks which are unilaterally doable.
Treatment groups
Trial outcomes
Primary outcomes
Grasp performance
Quantitative subtest of Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP-QtG). 6 GRASSP-QtG tasks in total, each task is graded from 0 (the task cannot be conducted at all) to 5 (the task is conducted without difficulties using the expected grasping pattern and upper limb function is unaffected).
Secondary outcomes
Qualitative upper limb function
Qualitative, sensation and strength subtest of GRASSP. 3 prehension ability tasks, of which each task is graded from 0 (the task cannot be conducted at all) to 4 (the task is conducted without difficulties and appropriate force) for each arm.
Independence in ADL
Spinal Cord Independence Measure III - Self-report (SCIM-SR). The SCIM-SR is assessed in 3 domains. The first domain "Self-Care" consists of 6 items and the scores range from 0 (e.g. full support needed) to 20 (e.g. completely independent). The second domain "Respiration and sphincter management" include 4 items whereas the third domain " Mobility" contain 9 items, both with scores from 0 - 40. Thus, the total score of SCIM-SR ranges from 0 to 100.
Upper Extremity Motor Score
International Standards for the Neurological Classification of Spinal Cord Injury examination (ISNCSCI-UEMS). Manual muscle testing of 5 upper extremity movements is conducted and scored. Each score is graded between 0 (no palpable or visible muscle contraction) to 5 (Full range of motion against maximum resistance) by the medical research council scale.
Handgrip strength
dynamometer
Sponsors and contacts
Click on the lead sponsor to view all of their trials.