Trial document





This trial has been registered retrospectively.
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  DRKS00020805

Trial Description

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Title

Gait analysis in acute and chronic SCI patients before and after training with wearable cyborg HAL - Hybrid Assistive Limb

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Previous studies using the HAL® (Hybrid Assistive Limb) have primarily focused on functional outcome parameters. The planned study is the first to provide evidence of the qualitative improvement of gait parameters after exoskelletal training with the HAL® in patients with spinal cord injuries. Inclusion criteria: Patients with a gait disorder due to an acute (<1 year) or chronic (> 1 year) spinal cord lesion.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00020805
  •   2020/02/12
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  •   yes
  •   Approved
  •   17-7875-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   Acute and chronic SCI
  •   G82 -  Paraplegia and tetraplegia
  •   S14 -  Injury of nerves and spinal cord at neck level
  •   S24 -  Injury of nerves and spinal cord at thorax level
  •   S34 -  Injury of nerves and lumbar spinal cord at abdomen, lower back and pelvis level
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Interventions/Observational Groups

  •   Pre test - 60 training sessions - post test
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

At the beginning and at the end of the individual training period (60 sessions, approx. 3 months), a gait analysis is carried out using inertial sensors to record the individual gait change.

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Secondary Outcome

Functional test procedures (10-meter walk test, 6-minute walk test, timed up-and-go test, WISCI-II score) are evaluated secondarily.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2018/04/23
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Patients with a gait disorder due to an acute (<1 year) or chronic (> 1 year) spinal cord lesion.

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Exclusion Criteria

Cardiopulmonary comorbidities, pressure ulcers on the lower extremity / breech region, infections, osteoporosis, thromboses / embolisms in the past, contractures or higher-grade spasticity of the lower extremity, body weight > 100 kg. Epilepsy, the presence of electronic medical devices that cannot be removed (e.g. pacemakers).

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Addresses

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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    • Mr.  Dr.  Alexis  Brinkemper 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    • Mr.  Dr.  Alexis  Brinkemper 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    • 44789  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/07/09
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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.