Trial document





This trial has been registered retrospectively.
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  DRKS00012690

Trial Description

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Title

Therapy accompanying use of VR glasses in hemiparetic children and adolescents

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The goal of this study is to investigate whether training in Virtual Reality can complement conventional physiotherapy and occupational therapy in children and adolescents with hemiparesis. Through a varied, repetitive and task- specific training over 12 weeks, the effects of the intervention with VR glasses on the functions of the upper extremity and the walking speed are to be examined. Children and adolescents with hemiparesis can train with VR glasses as part of the examination and it is checked whether this type of training leads to daily repetitions of movement and more fun and pleasure in movement. The parents of those affected are also involved and an independent and sustainable implementation of the training is checked. Access to innovative treatment options in neuropaediatrics plays just as important a role as the implementation of VR glasses after the first experiences and results of examinations. If the functions of the upper extremity and the walking speed improve, this has an impact on activities and participation in daily life. Children and adolescents with hemiplegia and their relatives would have a new possibility of individual daily training that supports the therapy goals.

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Brief Summary in Scientific Language

The design of the pilot study corresponds to a 12- week randomized controlled trial with single blinded evaluation. The n= 28 children and adolescents are examined with different tests at four measurement times.
The intervention with VR-glasses is carried out for children and adolescents every day for 15 minutes. The parents of the study participants receive a Samsung smartphone and the associated VR-glasses as well as the videos stored on the mobile phone. The used Samsung Galaxy S8 mobile phones run with the operating system Android 7.1. The Gear 360 Action Director software (SM-C200) is used to process video sequences. The video sequences show for example eating with both hands, playing the piano with both hands, tabletop soccer and pinball playing with both hands, playing table tennis with one hand as well as putting on pants and shoes and pulling back with both hands.

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Organizational Data

  •   DRKS00012690
  •   2018/05/29
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, Hochschule Fresenius Idstein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G80.2 -  Spastic hemiplegic cerebral palsy
  •   G81.1 -  Spastic hemiplegia
  •   G81.0 -  Flaccid hemiplegia
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Interventions/Observational Groups

  •   A smartphone and the corresponding VR glasses from Samsung are provided as technical aids. First, a video recording of 12 different video sequences is made with healthy children of the same age group. The following everyday movements are filmed with a head or helmet camera for 15 minutes:
    - Eating with both hands (Spaghetti, Pizza)
    - Playing flipper with both hands
    - Playing table soccer with both hands
    - Put on trousers and shoes and take them off again with both hands
    - Cycling, getting on and off, stopping, starting again

    The parents of the study participants carry out the intervention with VR glasses for 12 weeks every day for 15 minutes with the children and adolescents with hemiparesis. In the event of difficulties in carrying out the treatment, the physiotherapist or occupational therapist supports the parents. In addition, the parents of the study participants receive the smartphone and the corresponding VR glasses as well as the videos stored on the mobile phone. Parents are instructed how to put on the VR-glasses. The use of the smartphone is also explained so that parents can play the videos.
    In a previously described order of 1-12, 1 video per week (7 days) is shown daily for 15 minutes, preferably always at the same time each day, to the child or teenager. This ensures that the same video with the VR glasses is watched every day for 7 days. Every week the video changes so that the children and teenagers have seen all 12 videos in the 12 weeks. The children and adolescents with hemiparesis sit or stand, depending on their general condition and limitations, while they put on their VR glasses and watch the video.
    The parents of the study participants sit or stand next to the child or adolescent during the intervention in order to provide assistance in case of insecurity while sitting or standing. It is possible to schedule the therapy time with the VR-glasses to the time before or after physiotherapy or occupational therapy, so that a physiotherapist or occupational therapist can intervene in case of difficulties during the implementation. A follow-up appointment with the study leader takes place after 6 weeks in parallel with the measurement time after 6 weeks. Questions, suggestions and problems arising during the implementation can be discussed.
    For adult stroke patients undergoing intervention with VR glasses, it is recommended not to exceed the treatment time of 20 minutes. For this reason, a treatment time per day of 15 minutes in children and adolescents with hemiparesis is not exceeded. More than 15 "treatments" seem to be necessary to prove a positive effect.
  •   Patients in arm 2 do not receive any VR glasses for 12 weeks but will be presented with 2- dimensional images for review.
    If these children and adolescents receive a basic therapy (physiotherapy and/ or occupational therapy), it continues as usual.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoints are collected after the 12-week intervention or control phase and as a 6-month follow-up measurement as follows:
- The hand-finger motor function is determined with the "Nine Hole Peg Test". The time in hundredths of a second is measured, which the study participant needs for the execution.
- The function of the upper extremity is checked by means of the "Box and Block Test". The actions are measured within 60 seconds.
- Bimanual coordination of the upper extremities is tested with the "Movement ABC-2" manual dexterity tests. Here the time until the task is completed is measured.
- The balance and the risk of falling during an everyday movement task is measured with the "Timed-up & go test". The time used for the test is measured in seconds.
- The walking speed over a short distance of 10 meters is checked with the "Ten Meters Walking Test".
- The "Goal Attainment Scale" (GAS) provides a clear definition of objectives at the beginning of the study as well as a review of target achievement.
- The cardiopulmonary endurance capacity is determined with the "Six Minute Walking Test". The walking distance is measured in meters.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2018/03/23
  •   28
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Children from 6 to 19 years with hemiplegia.
A single affection of the arm or an affection of both - arm and leg - could be included.

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Exclusion Criteria

Children under the age of 6 and over 19 years are excluded. Experts recommend the computer entrance and thus the experience of virtual reality not before 6 years.
Children and adolescents with parents who do not speak and write German are also excluded from the study so that parents, children and adolescents can be provided with detailed information and care by the head of the study, pediatrician, physical - and occupational therapists.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • SRH University HeidelbergFaculty of Therapeutic Sciences
    • Mr.  Prof. Dr.  Michael Wilhelm  Jung 
    • Maria-Probst-Str. 3
    • D-69123  Heidelberg
    • Germany
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    • SRH University HeidelbergFaculty of Therapeutic Sciences
    • Mr.  Prof. Dr.  Michael Wilhelm  Jung 
    • Maria-Probst-Str. 3
    • D-69123  Heidelberg
    • Germany
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    • Hochschule Fresenius
    • Ms.  MSc  Jennifer  Höning 
    • Marienburgstr. 6
    • 60528  Frankfurt
    • Germany
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    • Hochschule Fresenius
    • Limburger Straße 2
    • 65510  Idstein
    • Germany
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Sources of Monetary or Material Support

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    • SRH University HeidelbergFaculty of Therapeutic Sciences
    • Mr.  Prof. Dr.  Michael Wilhelm  Jung 
    • Maria-Probst-Str. 3
    • D-69123  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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