Trial document




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  DRKS00025184

Trial Description

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Title

Effectiveness of game-based training of selective voluntary motor control in children with upper motor neuron lesions: A single-subject study

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Trial Acronym

SVMC training

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URL of the Trial

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Brief Summary in Lay Language

In this study, we aim to investigate the effectiveness of a specifically designed computer game to improve selective motor control (the ability to move individual joints in isolation) in children and adolescents with impaired selectivity.
To investigate the effectiveness of this game-based intervention, we chose a study design (single-subject design) with an individualized treatment approach, similar to the clinical setting. In the course of the study, both during the intervention and a few times before, selective joint control will be tested regularly to show baseline and progression. In addition, other parameters (e.g. muscle strength) are measured at individual time points.
The interactive computer game we have developed allows training selective motor control in a targeted manner. The game is controlled by the movement of a joint or the activation of a muscle group, for which we use two different systems. At the same time, the player receives feedback about any co-movements of other joints/muscles. The study includes ten therapy sessions of 45 minutes each, which are completed in addition to the normal therapy program.

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Brief Summary in Scientific Language

A reduction of selective voluntary motor control (SVMC) typically occurs in patients with an upper motor neuron lesion. Loss of SVMC can clinically manifest in reduced motor control and a multitude of involuntary movements. These impairments of SVMC interfere with functional movements of daily life activities and limit the patients’ independence. Our systematic review about interventions to improve SVMC revealed a lack of interventions that specifically target selective control. To fill this gap, we have developed an intervention exploiting the advantages of interactive computer play technology. Our intervention targets SVMC by either training selective activation of a target muscle or selective movement of a target joint without activating/moving any other undesired muscles/joints.
This study aims to investigate the effectiveness of this specifically developed game-based intervention to enhance SVMC in children and adolescents with an upper motor neuron lesion. Secondary aims are to determine the time to response, which improvement denotes a meaningful change, and concomitant changes in muscle strength.
Participants will receive 10 sessions of a specific intervention to improve SVMC additionally to their regular therapy (e.g., inpatient rehabilitation). Regular assessment of SVMC with the mini-assessment will be conducted throughout the intervention and during a preceding baseline phase. Prior to and after the intervention, there will be further clinical and other assessments (e.g., muscle strength, other SVMC assessments).

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Data are pseudo-anonymized. Our patient number is small and the description of the patients is comprehensive.

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Organizational Data

  •   DRKS00025184
  •   2021/04/28
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  •   yes
  •   Approved
  •   2021-00791, Kantonale Ethikkommission Zürich Stampfenbachstrasse 121 8090 Zürich Schweiz +41 43 259 79 70 info.kek@kek.zh.ch https://www.zh.ch/de/gesundheitsdirektion/ethikkommission.html#contact
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Secondary IDs

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Health Condition or Problem studied

  •   G80.0 -  Spastic quadriplegic cerebral palsy
  •   G80.1 -  Spastic diplegic cerebral palsy
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Interventions/Observational Groups

  •   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., inpatient rehabilitation).
    Two devices, the varioport, Becker Meditec or the ArmeoSenso (Version 1.0, Hocoma AG) will be used to control a game that specifically trains SVMC (selective joint movement/muscle activation and feedback about involuntary movements). Participants will complete 10 training sessions à approximately 40 minutes.
  •   Effects of the intervention will be compared to changes during a baseline phase of regular rehabilitation only.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   No
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Primary Outcome

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.

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Secondary Outcome

- 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 the assessgame.

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/06/20
  •   21
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   20   Years
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Additional Inclusion Criteria

Inclusion criteria: Acquired or congenital upper motor neuron lesion, aged between 6 and 20 years, impaired SVMC

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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.

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Addresses

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    • Kinder-Reha SchweizUniversitäts-Kinderspital Zürich
    • Mr.  Prof. Dr.  Hubertus  van Hedel 
    • Mühlebergstrasse 104
    • 8910  Affoltern am Albis
    • Switzerland
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    • Kinder-Reha SchweizUniversitäts-Kinderspital Zürich
    • Mr.  Prof. Dr.  Hubertus  van Hedel 
    • Mühlebergstrasse 104
    • 8910  Affoltern am Albis
    • Switzerland
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    • Kinder-Reha SchweizUniversitäts-Kinderspital Zürich
    • Ms.  MSc  Annina  Fahr 
    • Mühlebergstrasse 104
    • 8910  Affoltern am Albis
    • Switzerland
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Sources of Monetary or Material Support

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    • Swiss National Science Foundation (32003B_179471)
    • Wildhainweg 3
    • 3001  Bern
    • Switzerland
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Status

  •   Recruiting complete, follow-up continuing
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  •   0
  •   20
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.