Trial document




drksid header

  DRKS00020789

Trial Description

start of 1:1-Block title

Title

Effects of robotic training with the exoskeleton on the walking ability of patients after incomplete spinal cord injury

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study aims to investigate the effects of robotic exoskeletal training on the walking ability of patients after Spinal Cord Injury. Previous research has shown positive results for the exoskeleton, especially with regard to walking ability, muscle activity and quality of life. However it has not yet been investigated how the gait, measured by the tests planned here, changes in four weeks of exoskeletal training.
The planned study will involve patients with acute symptoms who have not yet received exoskeletal therapy. Before the first treatment and after four weeks of exo-training, the patients' ability to walk will be assessed. This is done by means of the walking tests Timed-up-and-go (TUG), 10-meter-walking-test, 6-minute-walking-test (6MWT) and the Walking Index for Spinal Cord Injury ll (WISCI ll). This is a single arm study.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The study aims to investigate the effects of robotic exoskeletal training on the walking ability of patients with incomplete paraplegia after Spinal Cord Injury. Previous research has shown positive results for the exoskeleton, especially with regard to walking ability, muscle activity and quality of life. However, how the gait changes in four weeks of exo-training, as measured by the tests planned here, has not yet been investigated.
The planned study is a single arm study in which the data will be evaluated after the end of the study. Independent of this study, a physician from the BG Klinikum Hamburg will determine the indication for exo-therapy, which will be performed by trained physiotherapists. None of the participants should have already trained with an exoskeleton before the start of the study. In addition, the test persons will be examined for their ability to walk before and after four weeks using the Timed Up and Go (TUG), 10-meter walking test and 6-minute walking test (6MWT), as well as the Walking Index for Spinal Cord Injury ll. These tests take place without the help of the exoskeleton.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

The data of the walking tests carried out will be passed on for further research of the study course Physiotherapy of the University of Lübeck if necessary. The anonymized patient data will be stored in electronic form for this purpose and can be made available on request.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00020789
  •   2020/02/20
  •   [---]*
  •   yes
  •   Approved
  •   20-007A, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G82 -  Paraplegia and tetraplegia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Training with the exoskeleton over four weeks. At the beginning and after four weeks the walking tests TUG, 10-meter walking test, 6-minute walking test (6MWT) and WISCI ll are performed without the exoskeleton
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

gait parameters:
- Elevated at: Start of therapy, at end of therapy
- Raised by: Time in the Timed-up-and-go Test

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

gait parameters:
- Elevated at: Start of therapy, at end of therapy
- Time in the 10-meter walking test, walking distance in meters in the 6-minute walking test, assessment of the assistance required for a walking distance of 10 meters using the Walking Index for Spinal Cord Injury ll
- Time between injury and start of therapy
- Size
- Weight
- Gender
- Cause of Spinal Cord Injury
- Age at time of accident
- Lesion height

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2020/02/25
  •   10
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Age 18 - 80 years
- Medical indication for training with the exoskeleton
- incomplete paraplegia of any cause
- no previous therapy with the exoskeleton

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- limited bony stability of spine, trunk, pelvis and lower extremities
- Restricted/no ability to walk due to other health causes such as malignant tumours, internal, cardiopulmonary or respiratory diseases
- Acute or subacute deep vein thrombosis of the leg
- open wounds on the contact surfaces of the exoskeleton
- lack of willingness to participate in exoskeletal therapy
- Isolation obligation due to multi-resistant pathogens

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität zu Lübeck
    • Ms.  Sarah  Fehrenkamp 
    • Am Brink 11
    • 23564  Lübeck
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • BG Klinikum Hamburg
    • Mr.  PD Dr. med.  Roland  Thietje 
    • Bergedorfer Straße 10
    • 21033  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universität zu Lübeck
    • Ms.  Sarah  Fehrenkamp 
    • Am Brink 11
    • 23564  Lübeck
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universität zu Lübeck
    • Ms.  Sarah  Fehrenkamp 
    • Am Brink 11
    • 23564  Lübeck
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universität zu Lübeck
    • Ms.  Sarah  Fehrenkamp 
    • Am Brink 11
    • 23564  Lübeck
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.