An interventional study of Unilateral robot-assisted therapy (RT) and Unilateral conventional occupational therapy (OT) in Cervical Spinal Cord Injury, sponsored by Swiss Paraplegic Research, Nottwil. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Treatment
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:
After cervical spinal cord injury (cSCI), motor and sensory impairments cause limitations in upper limb function which affect performance of activities of daily living (ADLs), independence and, ultimately, restrict participation and quality of life. Previous studies have shown that individuals with tetraplegia consider improvements in upper limb function to be one of the most significant factors in improving their quality of life. Small improvements in upper extremity function through rehabilitation can lead to substantial increases in independence with ADLs, quality of life and community integration. Repetitive and activity-based exercise can facilitate recovery after SCI by inducing practice-dependent brain and spinal plasticity. To achieve high numbers of repetitions, specialised rehabilitation centres apply innovative therapy methods like robot-assisted therapy (RT) aiming to improve upper limb function. Integrating robotic devices into daily clinical practice may save personnel resources while enabling high-intensive and individualised therapy using motivating feedback (e.g., gamification) and allowing for close monitoring of therapy sessions. Evidence suggests that robot-assisted interventions are safe, feasible and can reduce active assistance provided by therapists.
However, the clinical effectiveness of robot-assisted interventions for patients after cSCI has not been proven so far. For the devices used at the Swiss Paraplegic Centre (SPC) for upper extremity therapy after cSCI, there are only two studies to date that have followed a randomised controlled trial (RCT) design, and both were conducted with inadequate methodological quality (e.g. recruitment period one or two years post-injury respectively). This introduces a lot of variance and it thus remains open whether RT and conventional occupational therapy (OT) just have similar effects, or whether potential effects have been blurred due to imprecise study designs. Moreover, while both RCTs used the actively supporting ArmeoPower, internal analyses have shown that the passively supporting ArmeoSpring is the by far mostly used robotic device for training of the upper extremity inhouse. The ArmeoSpring is an instrumented arm orthosis with a spring mechanism (no actuators) for adjustable antigravity weight support for the arm in a large 3D workspace. However, neither of these robotic devices has ever been properly evaluated for clinical effectiveness .
Therefore, the aim of this study is to systematically investigate the effects of robot-assisted therapy (using the ArmeoSpring) on upper limb function compared to conventional occupational therapy in individuals with intermediate (between 2 weeks and 6 months after injury) cSCI.
Exclusion Criteria:
A stratified randomisation procedure will be used to allocate the sequence with either RT followed by OT or vice versa. The participants will performe unilateral robot-asssited therapy for 3 x 30 minutes per week for 6 weeks first, and then the unilateral conventional occupational therapy also for 3 x 30 minutes per week for 6 weeks.
Other: Unilateral robot-assisted therapy (RT) · Other: Unilateral conventional occupational therapy (OT)
A stratified randomisation procedure will be used to allocate the sequence with either OT followed by RT or vice versa. The participants will perform unilateral conventional occupational therapy for 3 x 30 minutes per week for 6 weeks first, and then unilateral robot-assisted therapy also for 3 x 30 minutes per week for 6 weeks.
Other: Unilateral robot-assisted therapy (RT) · Other: Unilateral conventional occupational therapy (OT)
RT 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).
The 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.
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).
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
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.
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
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.
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
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.
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Handgrip strength
dynamometer
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Arm control
Instrumented Action Research Arm Test (iARAT)
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Therapy intensity
amount of movement quantified by inertial measurement units (IMUs)
Time frame: 18 times during the 12 weeks interventions
Intrinsic Motivation
Intrinsic Motivation Inventory (IMI). The full IMI includes 45 items distributed across seven subscales, of which the applicable items and subscales can be chosen. Each item is graded between 1 (not at all true) to 7 (very true).
Time frame: 6 times during the 12 weeks interventions
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Study protocol
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Swiss Paraplegic Research, Nottwil