Trial document




drksid header

  DRKS00015254

Trial Description

start of 1:1-Block title

Title

The role of the somatosensory system in the balance control of lower-limb amputees

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

Trial Acronym

BCinA

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

We are studying how the body controls posture when a person is missing a lower limb and has to use a prosthetic device. We will measure how the body sways when it is in a quiet upright position. We will also perform standardized clinical balance tests.

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

Brief Summary in Scientific Language

The dynamics of the adjustment of center of pressure (CoP) has been utilized to study human pathologies characterized by impairments in balance control. This research will investigate the CoP adjustments that occur during upright standing in amputees wearing a prosthesis. The complexity of the CoP adjustments of unilateral transfemoral amputees and healthy participants will be quantified. These measures will be correlated to clinical data (i.e., Berg Balance Scale and the timed up-and-go test), to assess the neuromuscular status of the controlled limb. This allows to: (1) analyze compensatory mechanisms in amputees wearing a prosthetic device, and (2) evaluate new stimulation paradigms designed to restore sensory feedback.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015254
  •   2018/09/20
  •   [---]*
  •   yes
  •   Approved
  •   230/18, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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

  •   Lower-limb amputation
  •   Q72.0 -  Congenital complete absence of lower limb(s)
  •   Q72.9 -  Reduction defect of lower limb, unspecified
  •   S78.1 -  Traumatic amputation at level between hip and knee
  •   S78.9 -  Traumatic amputation of hip and thigh, level unspecified
  •   T13.6 -  Traumatic amputation of lower limb, level unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with unilateral lower-limb transfemoral amputation wearing a prosthesis will be tested in two standard clinical balance tests (Berg-Balance-Scale: 14 different short mobility tasks; Timed-Up-and-Go-Test: simple mobility test of balancing ability). Furthermore, the changes of the center of pressure (CoP) will be measured while patients are standing still on a force measurement platform. The complexity of CoP adjustments will be correlated to the clinical assessments of the first two tasks and data will be compared to participants without amputation (see arm 2).

  •   Healthy participants without an amputation (control group) will be tested in two standard clinical balance tests (Berg-Balance-Scale: 14 different short mobility tasks; Timed-Up-and-Go-Test: simple mobility test of balancing ability). Furthermore, the changes of the center of pressure (CoP) will be measured while participants are standing still on a force measurement platform. The complexity of CoP adjustments will be correlated to the clinical assessments of the first two tasks and data will be compared to participants with lower-limb amputation (see arm 1).

end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

While participants are standing still on a force measurement platform, data will be obtained about the changes of the center of pressure in their feet. This data will be analysed to be able to compare the complexity of CoP adjustments in participants with lower-limb amputation and the control group.

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

Secondary Outcome

General body balance abilities of the participants will be assessed with two standard clinical mobility tests (Berg-Balance-Scale and Timed-Up-and-Go-Test). The results of these tests are in the following correlated with the results from the CoP measurements.

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

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

Recruitment

  •   Planned
  •   2018/10/01
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Unilateral transfemoral (above the knee) amputations

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

Exclusion Criteria

Participants diagnosed with neurological diseases, cardiovascular or other orthopedic disorders will be excluded.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Laboratory for Biomedical MicrotechnologyDepartment of Microsystems EngineeringUniversity of Freiburg - IMTEK
    • Mr.  Prof.  Thomas  Stieglitz 
    • Georges-Koehler-Allee 102
    • 79110  Freiburg
    • 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
    • UNIVERSITÄTSKLINIKUM FREIBURGKlinik für Orthopädie und Unfallchirurgie /Tumorzentrum Freiburg - Comprehensive Cancer Center Freiburg CCCF
    • Mr.  Dr. med.  Georg  Herget 
    • Hugstetter Str. 55
    • D-79106  Freiburg
    • 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 other
    • Sanitätshaus Pfänder
    • Mr.  Theo  Falck 
    • Munzinger Str. 5c
    • 79111  Freiburg
    • 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
    • Laboratory for Biomedical MicrotechnologyDepartment of Microsystems EngineeringUniversity of Freiburg - IMTEK
    • Mr.  Dr.  Cristian  Pasluosta 
    • Georges-Koehler-Allee 102, Room: 102-00-208
    • 79110  Freiburg
    • 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
    • Laboratory for Biomedical MicrotechnologyDepartment of Microsystems EngineeringUniversity of Freiburg - IMTEK
    • Mr.  Dr.  Cristian  Pasluosta 
    • Georges-Koehler-Allee 102, Room: 102-00-208
    • 79110  Freiburg
    • 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
    • Laboratory of Biomedical Microtechnology, Department of Microsystems Engineering - IMTEK, University of Freiburg
    • Georges-Köler-Allee 102
    • 79110  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Wissenschaftliche Gesellschaft in Freiburg im Breisgau
    • Löwenstr. 16
    • 79098  Freiburg
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
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.