G82.4 G82.3 G82.5
Conditions
Interventions
Group 1: The study participation will be divided into three phases. First, the user takes part in a 4-12 week FES-training to increase fatigue resistance of the muscle groups relevant for grasping. BC
Sponsors
Universitätsklinikum Heidelberg - Klinik für Paraplegiologie - Experimentelle Neurorehabilitation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Sub-acute to chronic cervical SCI with time since injury = 6 months and missing or weak grasp function - Age over 17 - Sufficient voluntary shoulder movements and elbow flexion on one side, preferably on the dominant side - Capacity to consent
Exclusion criteria
Exclusion criteria: - Severe restrictions in the passive range of movement of the joints of the upper limb (> 30% of physiological range of motion) - Severe spasticity in the upper limbs - Skin diseases like infections, psoriasis, burns etc. at the upper limbs - Hyperesthesia of the upper limbs (upper and lower arm), which would not allow to increase FES intensity to a sufficient level of contraction force - Cardiac pacemaker, other active implants like medication pumps, phrenic pacemaker etc. - Metal implants in the direct area of current flow under the stimulation electrodes - Plexus paresis or other injuries / diseases that lead to extensive denervation of muscles of the upper limbs - Known history of epilepsy - Severe cognitive impairment or psychiatric conditions that restrict the use of a neuroprosthesis - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome of the Pilot study is the general feasibility of the robust generation of different grasp patterns including lateral and palmar grasp with the MoreGrasp neuroprosthesis and their natural control by attempted/imagined movements detected by an EEG-based Brain-Computer Interface (BCI). This general feasibility will be assessed by the „Grasp-and-Release-Test“ with and without the neuroprosthesis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes of body function in general during the 8 weeks of use of the active neuroprosthesis: - active/passive range of motion (ROM) of upper limb joints - neurological status assessed by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) - Medical Research Council Scale (MRC) of upper extremities muscles - spasticity assessed by the Modified Ashworth Scale (MAS) - pain assessed by a numeric analogue scale - depression assessed by Center for Epidemiological Studies Depressions-Scale (CES-D) - relative and absolute grip force generated by FES 2. Changes in functional abilities during the 8 weeks of use of the active neuroprosthesis assessed by: - Grasp-and-Release-Test (GRT) - Van-Lieshout-Test Short Version (VLT-SV) - Activities of daily living (ADLs) 3. Degree of satisfaction with the noninvasive neuroprosthesis assessed by: - Assistive Technology Device Predisposition Assessment (ATD-PA, Section D) - Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) 4. Changes in quality of life over the course of the use of the active neuroprosthesis assessed by: - Psychosocial Impact of Assistive Devices Scale (PIADS) - Anamnestic Comparative Self-Assessment (ACSA) | — |
Countries
Austria, Germany
Contacts
Public ContactUte Eck
Universitätsklinikum Heidelberg - Klinik für Paraplegiologie - Experimentelle Neurorehabilitation
Outcome results
None listed