Paresis of the hand due to all causes, particularly in cases of paraplegia, hemiparesis of various origins including after hemispherotomy, hemorrhage, stroke, or inflammatory diseases of the central nervous system.
Conditions
Interventions
Group 1: The study includes two intervention areas within the same cohort: the hand orthosis and the rehabilitation game. These are designed to assess, train, and improve residual motor functions over
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Age
3 Years to 17 Years
Inclusion criteria
Inclusion criteria: Neurological disorders presenting with hand paresis
Exclusion criteria
Exclusion criteria: Age < 3 years No detectable muscle activity Intractable spasticity Open injuries Drug or alcohol use Lack of ability to cooperate Severe psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuroorthosis: 1. Change in GRASSP Version 2 Prehension Performance and RULM score when using the orthosis in the paralyzed hand, compared with baseline at first use. 2. Proportion of participants achieving recovery of manual dexterity, defined as a Box and Block Test score 3. Increase in range of Motion (ROM) to the level of natural, healthy grasping (fist). Rehagame: 1. EMG Recording: F1 score for intention recognition 2. Movement can be reliably detected, as measured by classification accuracy and sensitivity or by a reduction in latency between the cue stimulus and movement intention to < 0.5 s. 3. EMG signals can be decomposed into individual motor units. | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuroorthosis: -Patient- and parent-reported satisfaction with performance of daily hand-related activities and ease of use, assessed on a visual Likert scale -Usability assessed by the System Usability Scale (SUS). -Measurable voluntary force applied with the orthosis and the paralyzed hand. -Changes in EMG signal characteristics during orthosis use. Rehagame: -Increase in residual movement, assessed by range of motion (ROM). -Motivation and acceptance, assessed by SUS. -Increase in the number of decomposable motor units with training. -Increase in RMS during voluntary movement compared with baseline after 12 weeks. Number of voluntary triggered movements, which can we decoded with machine learning. | — |
Countries
Austria, Germany, Italy, Norway, Switzerland, United Kingdom
Contacts
Public ContactFerdinand Knieling
Universitätsklinikum Erlangen
Outcome results
None listed