G80.0 G80.1
Conditions
Interventions
Group 1: This is a randomized, non-concurrent multiple-baseline design. Participants will receive 10 sessions of a game-based intervention to improve SVMC additionally to their regular therapy (e.g.,
Sponsors
Kinder-Reha SchweizUniversitäts-Kinderspital Zürich
Eligibility
Sex/Gender
All
Age
6 Years to 20 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Acquired or congenital upper motor neuron lesion, aged between 6 and 20 years, impaired SVMC
Exclusion criteria
Exclusion criteria: Exclusion criteria: Ataxia or dyskinesia, Botox or surgery prior = 3 months, non-compliance. Participants with contraindications for the application of TMS will be excluded from TMS assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is SVMC measured with a game-based mini-assessment repeatedly during baseline (5-8 times) and intervention phase (10 times). The mini-assessment encompasses an outcome parameter describing the accuracy of the movements and one describing the amount of involuntary movements occurring. These two parameters are combined to one primary outcome by means of z-scores relative to the baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Difference between changes during baseline and intervention phase (relative to the length of phase) in SVMC measured with the other outcome assessments (SCALE/SCUES, SI, and assessgame), muscle strength, and functional independence. - Active training time during intervention sessions and training session logs. - Number, type, and broad content (i.e., upper or lower limb focus, SVMC training yes or no) of other therapies the participant received during the baseline and intervention phase to investigate and control for a possible confounding effect. - Individual patient analysis of the primary outcome. - Repeated assessment of muscle strength during baseline and intervention phase (as for primary outcome). - Accuracy of movement control of the joint/muscle that will be trained to remain inactive. - Muscle strength and SVMC assessed with the game-based mini-assessment and SCALE/SCUES three months after the intervention and number, and type of therapies the participant attended during the follow-up period to determine whether changes are maintained. - The difference between changes during baseline and intervention phase in motor threshold and MEP amplitude/latency measured with TMS to infer about changes in the corticospinal tract. - The number of training sessions required until SVMC (assessed with the game-based mini-assessment) has improved by = 10% and by the meaningful change (determined in this study) compared to baseline levels. As studies about meaningful changes in SVMC are not available yet, we estimate this threshold via the standard error of measurement of several assessments of SVMC. One standard error of measurement corresponds roughly to changes of 10%. - Relevance/meaningfulness of improvements achieved during the intervention evaluated with a global rating scale. This will serve as an anchor to determine which improvement in SVMC denotes a meaningful change. - Preliminary responsiveness of two assessments of SVMC, the similarity index and t | — |
Countries
Switzerland
Contacts
Public ContactAnnina Fahr
Kinder-Reha SchweizUniversitäts-Kinderspital Zürich
Outcome results
None listed