Hand InjuriesNCT02890862
Three-dimensional Kinematic Motion Analysis of Finger and Wrist During Daily Activities
An observational study of Hand Injuries, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of healty persons, patients with tendon pathologies, arthrosis and dupuytren disease. In the future the new findings should assist the decision of surgical procedures.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Center for Reconstructive Surgery
Zurich, Canton of Zurich, 8091
About this study
Official title: Three-dimensional Kinematic Motion Analysis of Finger and Wrist During Daily
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.
- Conditions
- Hand Injuries
- Keywords
- Kinematics, Activity of Daily living, 3D motion analysis
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 20 healthy volunteers | Not described | |
| Dupuytren disease | 10 patients dupuytren disease | |
| Tendon pathology | 10 patients with tendon pathology | |
| wrist osteoarthritis | 10 patients with wrist osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Joint angle of finger and wrist (Goniometer)
Maximum range of motion will be compared between first and second measurement
Measured: 36 months
Secondary outcomes (2)
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.
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Biomechanics, ETH Zürich
- Responsible party
- Sponsor
- Investigators
- Maurizio Calcagni, PD Dr. med., Principal investigator, Plastic surgery and Handsurgery USZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890862
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0395
- Status last verified
- Oct 2018
- First submitted
- 18 Aug 2016
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Kinematic Motion Analysis of Finger and Wrist During Daily
- ClinicalTrials.gov ID
- NCT02890862
- Acronym / sponsor ID
- KEK-ZH-Nr. 2015-0395
- Conditions
- Hand Injuries
- Keywords
- Kinematics, Activity of Daily living, 3D motion analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Institute for Biomechanics, ETH Zürich
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 healthy volunteers | – | – |
| Dupuytren disease | – | –10 patients dupuytren disease |
| Tendon pathology | – | –10 patients with tendon pathology |
| wrist osteoarthritis | – | –10 patients with wrist osteoarthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of healty persons, patients with tendon pathologies, arthrosis and dupuytren disease. In the future the new findings should assist the decision of surgical procedures.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Joint angle of finger and wrist (Vicon)
Time frame: 36 months
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.
Joint angle of finger and wrist (Goniometer)
Time frame: 36 months
Maximum range of motion will be compared between first and second measurement
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Calcagni, PD Dr. med. principal investigator
Plastic surgery and Handsurgery USZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Injuries, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint angle of finger and wrist (Vicon) (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.