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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00011081 |
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Date of registration:
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07/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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15/06/2015 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00011081 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: basic science
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Rüdiger
Rupp |
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Address:
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Schlierbacher Landstraße 200 a
69118
Heidelberg
Germany |
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Telephone:
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-49(0)6221/562-9230 |
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Email:
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ruediger.rupp@med.uni-heidelberg.de |
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Affiliation:
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Klinik für Paraplegiologie - Expermimentelle Neurorehabilitation |
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Name:
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Ute
Eck |
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Address:
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Schlierbacher Landstraße 200 a
69118
Heidelberg
Germany |
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Telephone:
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+49(0)6221/56-39799 |
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Email:
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ute.eck@med.uni-heidelberg.de |
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Affiliation:
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Klinik für Paraplegiologie - Experimentelle Neurorehabilitation |
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Key inclusion & exclusion criteria
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Inclusion criteria: Humans with an age of 18 to 70 with and without spinal cord injury.
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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Paraplegia and tetraplegia
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able-bodied individuals
G82
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Intervention(s)
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Group 1: 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.
Group 2: 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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Primary Outcome(s)
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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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Source(s) of Monetary Support
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Bundesministerium für Bildung und Forschung Dienstsitz Berlin
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Ethics review
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Status: Approved
Approval date: 27/10/2014
Contact:
ethikkommission-I@med.uni-heidelberg.de
Ethikkommission der Medizinischen Fakultät Heidelberg
+49-6221-338220
ethikkommission-I@med.uni-heidelberg.de
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