Trial document




drksid header

  DRKS00009010

Trial Description

start of 1:1-Block title

Title

Use of the robotic asissted hand therapy system Manovo®Power in patients with a stroke

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

In this study will be investigated the intra and inter reliability with the grip strength measurement Manovo®Power.
Also will be evaluated the satisfaction of the patients and practiability of the device in the therapists point of view

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

Brief Summary in Scientific Language

In this study will be investigated the intra and inter reliability with the grip strength measurement Manovo®Power.
Also will be evaluated the satisfaction of the patients and practiability of the Devise in the therapists point of view

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

Organizational Data

  •   DRKS00009010
  •   2015/08/07
  •   2015/08/03
  •   yes
  •   Approved
  •   EKSG 15/078, Ethikkommission Sankt - Gallen (Schweiz)
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

  •   Impairment of the upper extremity after CVI
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   grip strength measurement
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   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

Investigating the intrater and interater - reliability of the Manovo®Power measuring Hand strength.
the Manovo®Power is a tool used to measure Hand strength.
The Biometrics E- Link Hand grip Dynamometer is a measuring tool to measure Hand strength.
The Hand strenght will be measured with the Manovo®Power on 2 days in the morning with an interval of 2-3 days inbetween (example: Mo-We-Fr or We-Fr-Mo)
The Hand strenght will also be measured with the Biometrics E- Link Hand grip Dynamometer on 2 days in the afternoon with an interval of 2-3 days inbetween (example: Mo-We-Fr or We-Fr-Mo)

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

Secondary Outcome

Investigating the correlation between the Manovo®Power assessment and Biometrics E-Link Hand grip Dynamometer.
Therby, a third measurement will be performed.
Evaluation on patients satisfaction and practicality from the therapist's point of view. The questionnaire will be specially develped to evaluate the patient's satisfaction, respectively the practcality of use.

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

Countries of Recruitment

  •   Switzerland
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
  •   2015/08/10
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

patients after stroke, primary event < 24 months, no additional diagnosis, which the treatment for improving the hand and arm function is negatively influenced.
age ≥18
A degree of active arm/ Hand function (Chedoke-
McMaster Stroke Assessment: handstadium:
2-7)
passive range of Motion
shoulder: Flexion/ABD≥ 60°
elbow: Deficit of extension ≤ 30°
hand wrist: extension ≥ 0°
fingerextension: ability to open the hand half way
ability to communicate in German language plus enough speech comprehension and appropriate cognitive abilities to implement simple tasks
written informed consent

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

Exclusion Criteria

severve sensory loss (NIH-Stroke
Scale: sensibility(arm) = 2 points (no surface and deep sensibility)
shoulder pain (Chedoke shoulder – pain ≥ 5)
severve/ global aphasia
epilepsy

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Neurologie und Neurorehabilitation
    • Mr.  Professor  Jürg  Kesselring 
    • Taminaplatz 1
    • 7317  Valens
    • Switzerland
    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 scientific-contact
    • Klinik für Neurologie und Neurorehabilitation
    • Mr.  Doktor  Jan  Kool 
    • Taminaplatz 1
    • 7317  Valens
    • Switzerland
    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
    • Klinik für Neurologie und Neurorehabilitation
    • Mr.  Stefan  Ortmann 
    • Taminaplatz 1
    • 7317  Valens
    • Switzerland
    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
    • Stiftung Valens und WalenstadtbergTaminaplatz 17317 Valens
    • Mr.  Professor  Jürg  Kesselring 
    • Taminaplatz 1
    • 7317  Valens
    • Switzerland
    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.