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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

Organizational Data

DRKS-ID:
DRKS00011081
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2016-10-07
Last update in DRKS:
2016-10-07
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

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.

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.

Health condition or problem studied

ICD10:
G82 - Paraplegia and tetraplegia
Free text:
able-bodied individuals
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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.
Arm 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.

Endpoints

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
Secondary outcome:
none

Study Design

Purpose:
Basic research/physiological study
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Paraplegiologie Heidelberg

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2015-06-15
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
20
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
70 Years
Additional 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.

Addresses

Primary Sponsor

Klinik für Paraplegiologie
Prof.Dr. Norbert Weidner
Schlierbacher Landstraße 200 a
69118 Heidelberg
Germany
Telephone:
+49 (0) 6221/ 562 -6322
Fax:
+49 (0) 6221/ 562 6345
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de/Willkommen.115090.0.html
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Paraplegiologie - Expermimentelle Neurorehabilitation
Dr. Rüdiger Rupp
Schlierbacher Landstraße 200 a
69118 Heidelberg
Germany
Telephone:
-49(0)6221/562-9230
Fax:
+49(0)6221/562-9234
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de/Neurorehabilitation.115101.0.html

Contact for Public Queries

Klinik für Paraplegiologie - Experimentelle Neurorehabilitation
Ute Eck
Schlierbacher Landstraße 200 a
69118 Heidelberg
Germany
Telephone:
+49(0)6221/56-39799
Fax:
+49(0)6221/562/9234
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de/Neurorehabilitation.115101.0.html

Principal Investigator

Klinik für Paraplegiologie - Expermimentelle Neurorehabilitation
Dr. Rüdiger Rupp
Schlierbacher Landstraße 200 a
69118 Heidelberg
Germany
Telephone:
-49(0)6221/562-9230
Fax:
+49(0)6221/562-9234
Contact per E-Mail
URL:
http://www.klinikum.uni-heidelberg.de/Neurorehabilitation.115101.0.html

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung Dienstsitz Berlin
Friedrichstraße 130 B
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-09-25
Ethics committee number:
S-511/2014
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-10-27

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study 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.
Background literature:
No Entry
Related DRKS studies:
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Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
No Entry