Comparing robot-assisted and conventional therapy for upper limb function in 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
This study is testing whether robot-assisted therapy or regular occupational therapy helps people with cervical spinal cord injuries improve their arm and hand function better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swiss Paraplegic Research, Nottwil Research network |
| Locations | 1 site (Nottwil, Canton of Lucerne) |
| Trial ID | NCT06775925 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of robot-assisted therapy using the ArmeoSpring compared to conventional occupational therapy for improving upper limb function in individuals with cervical spinal cord injury (cSCI). Participants will undergo both therapy forms in a randomized order, with each therapy lasting six weeks. The study includes baseline and intermediate assessments to measure improvements in arm and hand function. The goal is to determine which therapy is more effective in enhancing daily living activities and overall quality of life for patients with cSCI.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have experienced a traumatic or non-traumatic cervical spinal cord injury and are within 16 to 81 days post-injury.
Not a fit: Patients with severe concomitant neurological diseases or those whose upper limb function impairment is due to peripheral nerve lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies that enhance upper limb function and quality of life for individuals with cervical spinal cord injuries.
How similar studies have performed: While robot-assisted therapy has shown promise in other contexts, the clinical effectiveness specifically for patients with cervical spinal cord injury remains unproven, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nottwil, Canton of Lucerne
- Swiss Paraplegic Centre — Nottwil, Canton of Lucerne, Switzerland (Recruiting)
Study contacts
- Study coordinator: Mario Widmer, Dr. sc. ETH
- Email: mario.widmer@paraplegie.ch
- Phone: 0041 41 939 51 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.