Trial document





This trial has been registered retrospectively.
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  DRKS00011081

Trial Description

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Title

Comparison of training performance and effectiveness of two contol modes for assistive devices based on the voluntary activation of ear muscles

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Humans with paralyzed or amputated arms depend on assistive devices to interact with their environment. For human-machine interaction established technology is available using mouth-, chin, or eye-controlled interfaces. However, these devices often interfere with the patients’ residual functions. Sip-and-puff control e.g. cannot be used during speaking or eating. A muscle activity not involved in natural behaviours is ear wiggling. In former experiments we were able to show that almost everybody can learn to contract the ear muscles voluntarily.
Based on These results within this study two modes of electrical wheelchair control will be tested. One mode, the "lateralized, analogue control” measures the difference in contraction strengths between the left and right ear muscles to navigate the wheelchair. A stronger activation of e.g. the right ear causes a turn to the right. The second mode, the "bilateral digital coded control” uses sequences of short and long contractions of ear muscles to control driving. The test subjects are randomly assigned to either to the analogue control or the digital control group and train with a Computer one of the two methods 1 h per day for max. 10 days. The daily sessions are divided into two parts. In the first part of the session the participant performs several exercises, in the second part he navigates a Computer wheelchair through a virtual course.

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Brief Summary in Scientific Language

The main goal of the joint project TELMYOS is the development of a telemetric myoelectric ear muscle device to control assistive devices. The system should enable humans with complete cervical spinal cord injury or amputation of the arms to control technical aids and devices of their environment (e.g. neuroprosthesis of the arm, wheelchairs). It has been shown that people can activate their ear muscles voluntarily after training. The goal of this pilot study is to compare two different implementations of ear control with a focus on success and performance of training.
Therefore 20 adult subjects (10 ear wiggler/10 non ear wiggler) with und without spinal cord injury will be are included and randomly assigned to two groups of 10 subjects (5 non ear wigglers/5 ear wigglers). All study participants go through a study protocol of max. 10 days. The participants of the “analogue control” group train for 1 h/day to activate their ear muscles side dependent, the ones of the “digital control” group train sequences of short and long contractions of the muscles of both ears. The documented training parameters include reaction times for activation and relaxation, the max. rate of repetition, the duration of the contractions and the number of reliable levels of contraction force. At the end of each training session the participant navigates a virtual wheelchair through a standardized course. The results of the training as well as velocity, path length and collisions of the navigation are documented as measures of performance.

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Organizational Data

  •   DRKS00011081
  •   2016/10/07
  •   [---]*
  •   yes
  •   Approved
  •   S-511/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   G82 -  Paraplegia and tetraplegia
  •   able-bodied individuals
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Interventions/Observational Groups

  •   Training of bilateral, digital control: the individuals of this group perform in 2 weeks 10 days of a one-hour-training of temporal Patterns of bilateral activations of both ears. At the end of each session a navigation through a virtual parcour is performed, which is done by different activation patterns of both ears.
  •   Training of lateralized, analog control: the individuals of this group perform in 2 weeks 10 days of a one-hour-training of a lateralized activation of one ear. At the end of each session a navigation through a virtual parcour is performed, which is done by different degrees of activation of the right or left ear muscles.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Computerized measurements during each training session contain the following parameter:
reaction times of contraction and relaxation;
maximum contraction duration (between 60% and 80% of the maximal force); contraction rate (number of contractions in a 10 s frame);
degrees of graded ear muscle activation (holding a contraction between 20 % and 70 % for 10 s); degree of lateralized activation; speed, path length and collisions during navigation through a virtual obstacle course

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/06/15
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Humans with an age of 18 to 70 with and without spinal cord injury.

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Exclusion Criteria

cognitive limitations; mental disorder concerning cooperation and depression; dementia or other factors, which interfere the cooperation or the compliance of the patient/able-bodied subject;
subjects, who can activate the muscle of one ear; continuous artificial ventilation; active pacemaker; epilepsy, pregnancy; patients with spinal cord injury, who are not able to autonomously operate an electric wheelchair by a joystick; all circumstances that do not allow for a continuous study participation over 2 weeks.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Paraplegiologie
    • Mr.  Prof.Dr.  Norbert  Weidner 
    • Schlierbacher Landstraße 200 a
    • 69118  Heidelberg
    • Germany
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    • Klinik für Paraplegiologie - Expermimentelle Neurorehabilitation
    • Mr.  Dr.  Rüdiger  Rupp 
    • Schlierbacher Landstraße 200 a
    • 69118  Heidelberg
    • Germany
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    • Klinik für Paraplegiologie - Experimentelle Neurorehabilitation
    • Ms.  Ute  Eck 
    • Schlierbacher Landstraße 200 a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Schmalfuß, L., et al. "Steer by ear: Myoelectric auricular control of powered wheelchairs for individuals with spinal cord injury." Restorative neurology and neuroscience 34.1 (2015): 79-95.
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* This entry means the parameter is not applicable or has not been set.