Evaluation of upper limb motor performances using tablet-based tests
Organizational Data
- DRKS-ID:
- DRKS00009022
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2015-08-07
- Last update in DRKS:
- 2015-08-07
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
ReHaptix is a startup developing an app comprising a series of tests to allow patients with arm disabilities to measure their upper limb motor functions. The planned study aims at measuring performances of healthy subjects as reference norms for comparison with patients data, and validate the results by comparing them to existing validated clinical measures and evaluating the test-retest reliability of the results.
Brief summary in scientific language
ReHaptix is a startup developing an app comprising a series of tests to allow patients with arm disabilities to measure their upper limb motor functions. The study aims at measuring performances of healthy subjects as reference norms for comparison with patients data, and validate the results by comparing them to existing validated clinical measures and evaluating the test-retest reliability of the results.
Health condition or problem studied
- Free text:
- Patients with stroke (I64), multiple sclerosis (G35), Parkinson disease (G20) and ataxia (R27) who suffers from arm disabilities
- ICD10:
- I64 - Stroke, not specified as haemorrhage or infarction
- ICD10:
- G35 - Multiple sclerosis
- ICD10:
- G20 - Parkinson disease
- ICD10:
- R27 - Other lack of coordination
- ICD10:
- U50
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- We will collect data with healthy subjects of different age (6 age groups: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80) and gender (2 categories). Four tests on a tablet will be repeated 5 times with each hand: 1) Trace a spiral 2) Trace a star 3) Follow the dot 4) Hit the targets
- Arm 2:
- Patients (stroke, multiple sclerosis, Parkinson disease and ataxia): Four tests on a tablet will be repeated 5 times with each hand: 1) Trace a spiral 2) Trace a star 3) Follow the dot 4) Hit the targets Movement observation: 1) Tremor at rest 2) Action or Postural Tremor of hands 3) Finger Taps 4) Rapid Alternating Movements of Hands 5) Finger-to-nose test 6) Finger-finger test 7) Drawing of the Archimedes’ spiral on a pre-drawn pattern 8) Dysmetria test 9) Plate tapping test
Endpoints
- Primary outcome:
- The study aims at: 1) measuring performances of healthy subjects as reference norms for comparison with patients data 2) validate the results by comparing them to existing validated clinical measures 3) evaluating the test-retest reliability of the results
- Secondary outcome:
- The study also aims at developing additional outcome measures for the tablet based tests by analysing performances from healthy subjects and patients.
Study Design
- Purpose:
- Diagnostic
- Allocation:
- Non-randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Other
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Switzerland
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Kliniken Valens Valens
Recruitment period and number of participants
- Planned study start date:
- 2015-08-05
- Actual study start date:
- 2015-08-03
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 160
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 21 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- Healthy subjects will be eligible for the study if they have full hand function and can perform any activity of daily living involving the hands. Impaired subjects will be eligible for the study if they are mildly to moderately impaired. They should be capable to perform minimal arm and hand movements but suffer from impaired motor function hindering typical activities of daily living.
Exclusion Criteria
Healthy subjects will not be eligible for the study if they suffer from impaired motor function hindering typical activities of daily living. Impaired subjects will not be eligible for the study if they fully recovered and are not suffering from impaired motor function hindering typical activities of daily living.
Addresses
Primary Sponsor
- Address:
- ReHaptix GmbHDr. Marie-Christine FluetLeonhardstrasse 27, LEO B9.28092 ZurichSwitzerland
- Telephone:
- +41 76 454 2588
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Kliniken ValensDr. Jan KoolValens Rehabilitation Centre7317 ValensSwitzerland
- Telephone:
- +41 81 303 1403
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- ReHaptix GmbHDr. Marie-Christine FluetLeonhardstrasse 27, LEO B9.28092 ZurichSwitzerland
- Telephone:
- +41 76 454 2588
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Kliniken ValensDr. Jan KoolValens Rehabilitation Centre7317 ValensSwitzerland
- Telephone:
- +41 81 303 1403
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- ReHaptix GmbHLeonhardstrasse 27, LEO B9.28092 ZurichSwitzerland
- Telephone:
- +41 76 454 2588
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Kliniken ValensValens Rehabilitation Center7317 ValensSwitzerland
- Telephone:
- +41 81 303 1403
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission Kantonsspital St.Gallen /Haus 037 [Ethikkommission des Kantons St. Gallen]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:
- 2015-07-10
- Ethics committee number:
- EKSG 15/097
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-07-24
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