NCT06775925 Robot-assisted Vs. Conventional Occupational Therapy of the Upper Limb in Individuals with Cervical Spinal Cord Injury
| NCT ID | NCT06775925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Swiss Paraplegic Research, Nottwil |
| Condition | Cervical Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-12 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: * 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 * Impairment of upper limb function (GRASSP-QtG score unilateral \< 25 at baseline t0) * Ability to sit for 60 minutes and perform training with ArmeoSpring * Stratification parameters available Exclusion Criteria: * 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 * Severe concurrent medical disease or any other issue that in the opinion of the investigator would confound the results * Orthopedic limitations of the upper limb * Device specific contraindications * Participation in other interventional trial