- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02890862
Three-dimensional Kinematic Motion Analysis of Finger and Wrist During Daily Activities
Three-dimensional Kinematic Motion Analysis of Finger and Wrist During Daily
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Center for Reconstructive Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Volunteers of 20 healthy, right dominant hands
- 10 patients with tendon pathologies
- 10 patients with Dupuytren disease
- 10 patients with osteoarthritis of the wrist
- Patients older than 18 years
- Patient willing and able to give written informed consent to participate in the study
Exclusion Criteria:
- Inflammatory disease (e.g. rheumatoid arthritis)
- Pregnant women
- German language barrier to complete the questionnaires
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- Legal incompetence
- Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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20 healthy volunteers
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Dupuytren disease
10 patients dupuytren disease
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Tendon pathology
10 patients with tendon pathology
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wrist osteoarthritis
10 patients with wrist osteoarthritis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Joint angle of finger and wrist (Vicon)
Time Frame: 36 months
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Position of the Skin markers be measured with the Vicon cameras and the Joint angles will be calculated with matlab program.
Maximum range of motion will be compared between first and second measurement.
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36 months
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Joint angle of finger and wrist (Goniometer)
Time Frame: 36 months
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Maximum range of motion will be compared between first and second measurement
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective functional parameters: - daily activities: open a bottle, open a glass, type 3 words, write 3 words, turn a key, pick up small object, move heavy object (1/3kg), dart-throwing motion
Time Frame: 36 months
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Position of the Skin markers be measured with the Vicon cameras during daily activities and the joint angles will be calculated with matlab program.
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36 months
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Subjective functional parameters: - Mayo Wrist Score - Krimmer Wrist Score - Short Version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)
Time Frame: 36 months
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Mayo Wrist Score: On a scale from 0-100 points, 91-100 points is a excellent result, 81-90 a good results, 65-80 a satisfactory result and less than 65 points a poor result Krimmer Wrist Score: On a scale from 0-100 points, more than 80 is a excellent result, 65-80 a good result, 50-65 a satisfactory result and 0-50 a poor result. QuickDASH: At least 10 of the 11 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability. |
36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maurizio Calcagni, PD Dr. med., Plastic surgery and Handsurgery USZ
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr. 2015-0395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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