Patient SatisfactionNCT01869244
WOODCAST Hand Resting Splint - Study of User Experience
An observational study of Patient Satisfaction, run by Onbone Oy at 1 site in Finland.
Trial summary
The aim of the study is to collect comments form users of new type of hand resting splint. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patient Satisfaction
- How many people
- 18 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2013to Sep 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients whos treatment involves a hand resting splint. Finnish language skills (written and spoken).
Who may be able to join
- patient treatment involves hand resting splint; age of patient 18 - 90 years; skills with language Finnish language (written and spoken)
Who cannot join
- decreased co-operation of the patient; patient with multiple illnesses; malignancy; an illness affecting the general health.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: User Experience From WOODCAST 2mm Hand Resting Splint
The aim of the study is to collect comments form users of new type of hand resting splint.
Read the detailed description
An ecologically friendly and biodegradable wood-plastic composite cast (WOODCAST) is used as a hand resting splint in this study.
- Conditions
- Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
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 |
|---|---|---|
| hand resting splint | Patients with hand resting splint treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
User satisfaction
After using hand resting splint for two weeks, patient will fill a questionaire. In the questionaire patient is asked to assess the used splint (e.g. functional performance, visual appearance), by giving points (from 1 to 10 points). Patient will use two splints from different materials during the treatment (both of the splint will be assessed by the patient).
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onbone Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nina Lindfors, PhD, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869244
- Sponsor's protocol ID
- 152/13/03/02/2013
- Status last verified
- Jun 2017
- First submitted
- 31 May 2013
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Experience From WOODCAST 2mm Hand Resting Splint
- ClinicalTrials.gov ID
- NCT01869244
- Acronym / sponsor ID
- 152/13/03/02/2013
- Conditions
- Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Onbone OyIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Jun 2013 (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.
The aim of the study is to collect comments form users of new type of hand resting splint.
Detailed description
An ecologically friendly and biodegradable wood-plastic composite cast (WOODCAST) is used as a hand resting splint in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hand resting splint | – | –Patients with hand resting splint treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whos treatment involves a hand resting splint. Finnish language skills (written and spoken).
Key inclusion criteria (1 listed)
- patient treatment involves hand resting splint; age of patient 18 - 90 years; skills with language Finnish language (written and spoken)
Key exclusion criteria (1 listed)
- decreased co-operation of the patient; patient with multiple illnesses; malignancy; an illness affecting the general health.
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
User satisfaction
Time frame: 2-4 weeks
After using hand resting splint for two weeks, patient will fill a questionaire. In the questionaire patient is asked to assess the used splint (e.g. functional performance, visual appearance), by giving points (from 1 to 10 points). Patient will use two splints from different materials during the treatment (both of the splint will be assessed by the patient).
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 14 Jun 2017.
- Information of the productLink provided by the sponsor.
- 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.
Nina Lindfors, PhD, MD principal investigator
Helsinki University Central Hospital
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 Patient Satisfaction, run by Onbone Oy at 1 site in Finland.
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 1 inclusion and 1 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 14 Jun 2017. 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 Finland. 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?
User satisfaction (time frame: 2-4 weeks). 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 14 Jun 2017.