Robot-assisted Vs. Conventional Occupational Therapy of the Upper Limb in Individuals with Cervical Spinal Cord Injury
Robot-assisted Vs. Conventional Occupational Therapy of the Upper Limb in Individuals with Cervical Spinal Cord Injury: the Armeo X-over Trial
Swiss Paraplegic Research, Nottwil
40 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria8
- 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
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Interventions
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.
Locations(1)
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NCT06775925