G82.3 G82.4 G82.5
Conditions
Interventions
Group 1: The target group for this study comprises individuals with cervical spinal cord injury. In this context, the onset of paralysis should be at least 2 months ago. These individuals exhibit impa
Sponsors
Universitätsklinikum Heidelberg - Klinik für Paraplegiologie - Sektion Experimentelle Neurorehabilitation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • People with cervical spinal cord injury (SCI), at least 2 months after SCI, with weak or absent hand or grasp function • Age over 18 • Sufficient preserved voluntary shoulder movements and elbow flexion on at least one, ideally the dominant side of the body • Capacity to provide informed consent
Exclusion criteria
Exclusion criteria: • Significant limitations of passive joint mobility (contractures) of arms and hands (>30% of physiological range of motion) • Excessive spasticity in the arms • Skin disorders on the arms (inflammations/infections, psoriasis, eczema, burns, etc.) • Hyperesthetic areas on the arms (upper and lower arm) preventing achieving sufficient muscle contraction strength • Presence of a pacemaker or other active implants, such as (medication) pumps or diaphragm pacemakers • Metal implants in the direct flow area of the stimulation electrodes • Lesions of the brachial plexus with consequent paresis or other diseases or injuries leading to significant denervation of arm and hand muscles (FES stimulation only possible in innervated muscles!) • Known seizure disorder (epilepsy) • Higher cognitive impairments or psychiatric disorders that would limit the application of the neuroprosthesis • Pregnancy • Febrile infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of the study is to evaluate the functionality of and the user satifaction with the SmartSense4Life system. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary goal of the study is to examine and assess the user-friendliness and ergonomics of the system. The focus here is on capturing user experience in terms of intuitive usability and optimal ergonomic features. | — |
Countries
Germany
Contacts
Public ContactRüdiger Rupp
Universitätsklinikum Heidelberg - Klinik für Paraplegiologie - Sektion Experimentelle Neurorehabilitation
Outcome results
None listed