Robot-assisted Vs. Conventional Occupational Therapy of the Upper Limb in Individuals with Cervical Spinal Cord Injury

Launched by SWISS PARAPLEGIC RESEARCH, NOTTWIL · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to find out whether robot-assisted therapy, using a device called ArmeoSpring, is more effective than traditional occupational therapy for helping people with cervical spinal cord injuries (cSCI) improve their arm and hand function. Participants in the study will receive both types of therapy one after the other, with the order assigned randomly. This means that some participants will try robot-assisted therapy first, while others will start with conventional therapy. Each therapy session will last 30 minutes and will occur three times a week for six weeks.

To be eligible for the trial, participants should be between 16 and 81 days post-injury and have a specific level of injury in their cervical spine (C1-T1) that affects their upper limb function. They should also be able to sit for 60 minutes and participate in training with the robot. Throughout the study, participants will undergo assessments to track their progress at the beginning, midway, and at the end of each therapy phase. If they complete the study before 150 days after their injury, they may also have a follow-up assessment. This trial is currently recruiting participants of all genders who meet these criteria.

Gender

ALL

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