G82.02 G82.60
Conditions
Interventions
Group 1: An initial screening determines whether inclusion and exclusion criteria are met. Furthermore, the subject's degree of denervation is checked.
After study inclusion Functional electrical sti
Sponsors
Universitätsklinikum Heidelberg, Klinik für Paraplegiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Chronic spinal cord injury with time since injury > 9 months; cervical spinal cord injury level C3-C5; no voluntary finger and hand movement; Sufficient passive mobility of hand and finger joints; Sufficient voluntary shoulder movements and ideally elbow flexion on one side
Exclusion criteria
Exclusion criteria: Cardiac pacemaker, other active implants like pumps, phrenic pacemaker; Known history of epilepsy; Metal implants in the direct area of current flow under stimulation electrodes; Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary outcome is the suitability for daily use of the neuroprosthesis measured with the Grasp-and-Release-Test (GRT) and the van Lieshout-Test (VLT): During application of the GRT, which is directly measuring the functional capabilities of the hand, study participants are asked to grasp, move and release objects as often as possible within a 2 minute time limit. The test consists of six different tasks, each of which asks for a higher level of grip force and fine motor skills by demanding the transfer of different kinds of objects (blocks, pegs, paperweights, cans and VHS cassettes and simulated pressure of putting a fork in a cooked potato). Successful attempts are divided by the overall number of attempts to give a success rate of successfully moved objects. The mean success rate of all participates for each type of object is being calculated and comparison is made between the mean success rate with the system turned on and off, in order to measure direct impact of the neuroprosthesis. The VLT assesses general function of the upper extremities and lists ten items including arm extension, thumb closure, finger strength, pen grip, and fine motor skills like lighting a match or grasping and holding a coin. Again this test is performed both with the system turned on and off. Furthermore, these tests are carried out on three different occasions: First, after finishing the training period, when the participant is being given the actual electrode sleeve and using the neuroprosthesis for the first time. Second, after 8 weeks of application at home, the subject will take part in the tests again and for a third time after another 8 weeks, when the application phase ends and the participant is asked to return the neuroprosthesis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include change in body functions and change in independence as well as an assessment of device satisfaction. All assessments were chosen with the aim to cover all of the domains introduced by the International Classification of Function (ICF) of the WHO. In detail these are: Neurological examination of the upper extremities according to International Standards for Neurological Classification of Spinal Cord Injury (ISSNCSCI) Range of Motion Medical Research Council Motor Scale (MRC) Modified Ashworth Scale (MAS) Beck-Depressions-Inventar II (BDI II) Center for Epidemiological Studies Depression Scale (CES-D) Visual analogue scale for pain (VAS) Anamnestic Comparative Self-Assessment (ACSA) These assessments are done during each of the participant's four (or five, including the follow up) visits. Furthermore, measurements to assess device satisfaction and a possible impact on the level of independence include: The Psychosocial Impact of Assistive Devices Scale (PIADS) Assistive Technology Device Predisposition Assessment (Section D) Canadian Model of Occupational Performance (COPM) Capabilities of Upper Extremities (CUE) Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) These patient reported outcomes are being assessed during the application phase, that is 8 weeks after the neuroprosthesis has been handed out to the participant (mid application session) and 16 weeks after its provision (end of application session). | — |
Countries
Germany
Contacts
Public ContactPetra Rauch
Universitätsklinikum Heidelberg, Klinik für Paraplegiologie
Outcome results
None listed