Trial document





This trial has been registered retrospectively.
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  DRKS00012298

Trial Description

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Title

Evaluation of balance and gait stability in patients with incomplete spinal cord injury - a prospective study

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study the Balance and the gait stability from patients with incomplete spinal cord injury vs. healthy People should be evaluated. For this is made a balancetest and a pedobarographic Analysis. Additionally the Fear of Fall and Life Quality is tested.

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Brief Summary in Scientific Language

This prospective, controlled diagnostic study tests patients with incomplete spinal cord injury vs. healthy People. The Center of Pressure is measured, a pedobarographic analysis should be done plus the FES-I and SF 36 is accomplished.

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Organizational Data

  •   DRKS00012298
  •   2017/04/10
  •   [---]*
  •   yes
  •   Approved
  •   16119, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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

  •   G82 -  Paraplegia and tetraplegia
  •   Incomplete spinal cord injury
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Interventions/Observational Groups

  •   patients with incomplete spinal cord injury (balancetest, pedobarographic Analysis, FES-I, SF 36)
  •   healthy people (balancetest, pedobarographic Analysis, FES-I, SF 36)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Length of the Center of Pressure, measured with the pressure plate emed -q100

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Secondary Outcome

Gait Line (pedobarographic Analysis)Fear of Fall (FES-I)
Life Quality (SF 36)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/02/23
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

incomplete spinal cord injury sub L 1
18 - 65 years
chronic SCI (spinal cord injury) > 1 year
AIS D
incomplete paraparesis below neurological Level
incomplete motoric function preserved
at least half of the key muscle have muscle grade > 3

Healthy People:
18 - 65 years
no clinicopathological results

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Exclusion Criteria

no ability stand and walk independently
barefoot measurement is not possible
use of orthopaedic and prosthetic devices

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Addresses

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    • BG Klinikum Murnau
    • Professor-Küntscher-Straße 8
    • 82418  Murnau
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Biomechanik, BG Klinikum Murnau gGmbH
    • Mr.  Hannes  Wackerle 
    • Professor-Küntscher-Straße 8
    • 82418  Murnau
    • Germany
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    • Institut für Biomechanik, BG Klinikum Murnau gGmbH
    • Mr.  Hannes  Wackerle 
    • Professor-Küntscher-Straße 8
    • 82418  Murnau
    • Germany
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Sources of Monetary or Material Support

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    • BG Klinikum Murnau
    • Professor-Küntscher-Straße 8
    • 82418  Murnau
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/05/12
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* This entry means the parameter is not applicable or has not been set.