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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02890862
Other study ID # KEK-ZH-Nr. 2015-0395
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date December 2017

Study information

Verified date October 2018
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Development of reliable and objective evaluation methods is required for natural upper-extremity tasks. Three-dimensional imaging measurement techniques are a powerful tool for quantitative assessment of multijoint movements.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University Hospital Zurich, Center for Reconstructive Surgery Zurich ZH

Sponsors (2)

Lead Sponsor Collaborator
University of Zurich Institute for Biomechanics, ETH Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Joint angle of finger and wrist (Vicon) 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. 36 months
Primary Joint angle of finger and wrist (Goniometer) Maximum range of motion will be compared between first and second measurement 36 months
Secondary 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 Position of the Skin markers be measured with the Vicon cameras during daily activities and the joint angles will be calculated with matlab program. 36 months
Secondary Subjective functional parameters: - Mayo Wrist Score - Krimmer Wrist Score - Short Version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH) 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
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