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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00009010 |
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Date of registration:
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07/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Use of the robotic asissted hand therapy system Manovo®Power in patients with a stroke
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Scientific title:
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Use of the robotic asissted hand therapy system Manovo®Power in patients with a stroke |
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Date of first enrolment:
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10/08/2015 |
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Target sample size:
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50 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00009010 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Jan
Kool |
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Address:
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Taminaplatz 1
7317
Valens
Switzerland |
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Telephone:
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0041 (0) 81 303 1403 |
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Email:
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jan.kool@kliniken-valens.ch |
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Affiliation:
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Klinik für Neurologie und Neurorehabilitation |
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Name:
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Stefan
Ortmann |
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Address:
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Taminaplatz 1
7317
Valens
Switzerland |
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Telephone:
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0041 (0) 81 303 1397 |
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Email:
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stefan.ortmann@kliniken-valens.ch |
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Affiliation:
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Klinik für Neurologie und Neurorehabilitation |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
18 Years
Age maximum:
95 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Impairment of the upper extremity after CVI
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Intervention(s)
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Group 1: grip strength measurement
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Primary Outcome(s)
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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)
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Stiftung Valens und WalenstadtbergTaminaplatz 17317 Valens
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Ethics review
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Status: Approved
Approval date: 13/07/2015
Contact:
Ethikkommission Kantonsspital St.Gallen /Haus 037 [Ethikkommission Sankt - Gallen (Schweiz)]
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