Use of the robotic asissted hand therapy system Manovo®Power in patients with a stroke
Organizational Data
- DRKS-ID:
- DRKS00009010
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2015-08-07
- Last update in DRKS:
- 2015-08-07
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
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
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
Health condition or problem studied
- Free text:
- Impairment of the upper extremity after CVI
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- grip strength measurement
Endpoints
- 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)
- 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.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Switzerland
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Klinik für Neurologie und Neurorehabilitation, Kliniken Valens 7317 Valens
Recruitment period and number of participants
- Planned study start date:
- 2015-08-10
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 50
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 95 Years
- 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
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
Addresses
Primary Sponsor
- Address:
- Klinik für Neurologie und NeurorehabilitationProfessor Jürg KesselringTaminaplatz 17317 ValensSwitzerland
- Telephone:
- 0041 (0) 81 303 14 09
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://kliniken-valens.ch
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Neurologie und NeurorehabilitationDoktor Jan KoolTaminaplatz 17317 ValensSwitzerland
- Telephone:
- 0041 (0) 81 303 1403
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://kliniken-valens.ch
Contact for Public Queries
- Address:
- Klinik für Neurologie und NeurorehabilitationStefan OrtmannTaminaplatz 17317 ValensSwitzerland
- Telephone:
- 0041 (0) 81 303 1397
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://kliniken-valens.ch
Principal Investigator
- Address:
- Klinik für Neurologie und NeurorehabilitationDoktor Jan KoolTaminaplatz 17317 ValensSwitzerland
- Telephone:
- 0041 (0) 81 303 1403
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://kliniken-valens.ch
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Stiftung Valens und WalenstadtbergTaminaplatz 17317 ValensTaminaplatz 17317 ValensSwitzerland
- Telephone:
- 0041 (0)81 303 11 11
- Fax:
- 0041 (0)81 303 11 00
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kliniken-valens.ch
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission Kantonsspital St.Gallen /Haus 037 [Ethikkommission Sankt - Gallen (Schweiz)]Rorschacherstrasse 95CH-9007 St.GallenSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.sg.ch/home/gesundheit/ethikkommission.html
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-06-01
- Ethics committee number:
- EKSG 15/078
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-07-13
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry