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NCT06775925
Robot-assisted vs. Conventional Occupational Therapy of the Upper Limb in Individuals With Cervical Spinal Cord Injury
Conditions: Cervical Spinal Cord Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Swiss Paraplegic Research, Nottwil
Location: Swiss Paraplegic Centre Nottwil Canton of Lucerne
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 trials
Source: ClinicalTrials.gov (NCT06775925). StuddyBuddy aggregates publicly available trial information.