Trial document




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  DRKS00015524

Trial Description

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Title

Pilot study on the effects of different proprioceptive stimulation conditions on motor functions using the example of the knee angle

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Damage to the central nervous system (CNS) can lead to insecure gait. In the long term, the non-normal gait pattern can cause further health problems such back or joint pain, further reducing mobility. Thus, there is a high need for therapies aiming at an improvement of movement patterns towards normal gait. A specific therapeutical challenge in these patients is posed by their limitations in their position sense. To compensate for the impairment in this intrinsic joint position sense and the sense for body posture aiming at an normalization of the gait pattern, movement feedback mediated by therapists or devices is successfully applied. By conscious perception of the deviations from the normal gait pattern, the patients can actively correct their gait pattern.
One possibility to change the conscious perception of joint positions and / or to trigger an unconscious, reflexogenic activation of muscles is to apply a proprioceptive (proprioception = sensation of joint and body position) stimulation via vibratory stimuli. Up to now those vibratory stimuli have only been applied in static conditions (fixed joint angles) and not for correction of joint angles during walking.
In the forefront of a study involving patients, a variety of vibration parameters (amplitude, frequency, location (tendon/muscle)) are systematically tested on the thigh of able-bodied individuals in seating position on their effect on the knee angle.
The knee angle is measured with a camera system recording the position of 7 retroflective markers attached to the chosen leg. During the experiment, the individual sits on a soft mat on a table and wears a blindfold. To generate vibratory stimuli on the thigh a commercially available system is used. The vibrator is pressed on the respective location (muscle or tendon area on the thigh) with a defined force during a defined time span by the assessor. In different parts of the experiment the individual is asked to solve certain tasks, e.g., “please try to reach a knee angle of +30°, as soon as a verbal start signal is given!”. In total, 48 sessions with a duration of 30 seconds and 32 sessions with a maximum duration of 5 seconds will be conducted.

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Brief Summary in Scientific Language

Damage to the central nervous system (CNS) can lead to insecure gait. In the long term, the non-physiological gait pattern can cause further problems due to overload problems like back or joint pain, further reducing mobility. Thus, there is a high need for therapies aiming at a normalization of movement patterns towards a normal gait. A special therapeutic challenge in these patients is posed by their limitations in proprioception. To compensate for the impaired proprioception aiming at an improvement in gait, movement feedback mediated by therapists or devices is successfully applied. By conscious perception of the deviations from a normal gait pattern, the patients are able to correct their gait pattern. One possibility to change the conscious perception of joint positions and / or to trigger an unconscious, reflexogenic activation of muscles is to apply a proprioceptive stimulation via vibratory stimuli. Up to now this kind of stimulation has only been applied in static conditions and not for a correction of gait during walking. Furthermore, it has not yet been applied within the framework of a closed-loop feedback algorithm.
Before a study on patients can take place, a variety of vibration parameters (amplitude, frequency, location (tendon/muscle belly)) are systematically tested on the thigh of able-bodied individuals in seating position regarding the effects on the knee angle.
The knee angle is measured with a camera system recording the position of 7 retroflective markers attached to the chosen leg. During the experiment, the individual sits on a soft mat on a table and wears a blindfold. To generate vibratory stimuli on the thigh a commercially available system is used. The vibrator is pressed on the respective location (muscle or tendon area on the thigh) with a defined force during a defined time span by the assessor. In different parts of the experiment the individual is asked to solve certain tasks, e.g., “please try to reach a knee angle of +30°, as soon as a verbal start signal is given!”. In total, 48 sessions with a duration of 30 seconds and 32 sessions with a maximum duration of 5 seconds will be conducted.

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Organizational Data

  •   DRKS00015524
  •   2018/10/18
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  •   yes
  •   Approved
  •   S-593/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   healthy individuals and individuals with an incomplete spinal cord injury above (AIS C, D) above Th11
  •   G82.29 -  [generalization G82.2: Paraplegia, unspecified]
  •   G82.59 -  [generalization G82.5: Tetraplegia, unspecified]
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Interventions/Observational Groups

  •   Proprioceptive stimulation by vibration, systematic testing of all combinations of the vibration parameters amplitude (1mm, 2mm), location (tendon, muscle) and vibration frequency (0, 20, 40, 60, 80, 100, 120, 140 Hz) in randomized order. The experimental conditions "passive static" (leg relaxed), "active static" (individual is asked to maintain a specific knee angle) and "active dynamic" (individual is asked to reach a specific knee angle during vibration starting from the relaxed position) are passed through. In the experimental conditions "active static" and "passive static", vibration is applied for 25 seconds per parameter combination after which the course of the knee angle is recorded for more 5 seconds. In "active dynamic", the session is ended by the individual, or stopped automatically after 5 seconds. During proprioceptive stimulation, the vibration device is pressed on the respective skin area with 50 ± 10 N by the assessor.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

"passive static" and "active static": Change in knee angle relative to starting position over 25 seconds vibration. "Active dynamic": Deviation of the angle produced by the individual from the target angle.

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Secondary Outcome

The results of the Rydel-Seiffer-Test (tuning fork test to quantify vibratory sense) at epicondylus medialis and lateralis of the leg used in the experiment at 4 points in time (before the first session, after the last session, and in between experimental conditions).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/10/02
  •   25
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Healthy individuals:
age 18 - 50 years
Patients:
-age 18 - 50 years
-incomplete spinal cord injury (AIS C, D) above Th11
-time after onset of paralysis > 6 weeks
-ambulates (with walking aids) at least 5 min. without pause

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Exclusion Criteria

Pregnancy, implants in the examined leg, pain / neurological (= peripheral nerve damage) / orthopedic pre-existing problem in the examined leg, acute and chronic tendon or ligament injuries, not fully healed fractures in the examined leg, skin irritations / eczemas / inflammations / grazes or other wounds on the thigh of the examined leg. Additionally in patients: Strong spasticity (MAS ≥ 10) in focal leg.

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Addresses

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    • Klinik für Paraplegiologie - Expermimentelle Neurorehabilitation
    • Mr.  PD Dr.  Rüdiger  Rupp 
    • Schlierbacher Landstraße 200 a
    • 69118  Heidelberg
    • Germany
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    • Sektion experimentelle Neurorehabilitation, Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
    • Mr.  Daniel  Schließmann 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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    • Sektion experimentelle Neurorehabilitation, Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
    • Ms.  Ute  Eck 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Paraplegiologie - Expermimentelle Neurorehabilitation
    • Mr.  PD Dr.  Rüdiger  Rupp 
    • Schlierbacher Landstraße 200 a
    • 69118  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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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.