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Wrist FractureNCT06942546

Use and Meaning of Wrist Orthosis After Distal Radius Fracture

An observational study of Wrist Fracture and Distal Radius Fracture, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to investigate the use and meaning of wrist orthosis in everyday occupation after cast removal for adults with non-surgical treatment of distal radius fracture. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Wrist Fracture, Distal Radius Fracture
What is being tested?
Wrist orthosis
Type of treatment
Medical device
How many people
30 participants
Where
1 siteSweden
Study dates
15 Sep 2019to 11 Apr 2025
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult whit distal radius fracture Treated without surgery, but with casting for 25-31 Days Gets rehabilitation at Sjukhusen i väster/Alingsås lasarett or in Primary care rehabilitation in Alingsås

Who may be able to join

  • adults with unilateral distal radius fracture, non-operated, treated with cast for 25-31 Days
  • participants shall be treated at Sjukhusen i väster/Alingsås lasarett and get rehabilitation from occupational therapist in hospital rehabilitation clinic or in primary care rehabilitation clinic in Alingsås

Who cannot join

  • At time for decasting are pain free and have less than 20 degrees reduction of ROM in the wrist
  • Another disease or injury that affects pain, joint mobility and/or strength such as rheumatoid arthritis or neurological disease.
  • Not able to communicate in Swedish, due to self-report Formulas and interview

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Sjukhusen i väster Rehabmottagning Alingsås

    Alingsås, 44183

Other trials in Sweden

About this study

Official title: The Use and Meaning of Wrist Orthosis for Persons With Distal Radius Fracture After Cast Removal

The aim of this study is to investigate the use and meaning of wrist orthosis in everyday occupation after cast removal for adults with non-surgical treatment of distal radius fracture.

Read the detailed description

To be able to do meaningful occupations in everyday life is important for human health and well-being. We use our hands in mostly activities and the hands is also used to interpret and express feelings as a social link to others. A traumatic hand injury, such as a distal radius fracture (DRF), alter the conditions for everyday occupation for the person affected.

DRF affects 25,000 people in Sweden each year. The treatment is either conservative with a plaster cast for approximately four weeks, or surgical. At time for cast removal the fracture is clinical stable, but cannot withstand full load in everyday occupations. Normally the person has difficulties to grip and to use the hand.

The occupational therapist (OT) provide the person with information, training program and often a wrist orthosis. The purpose of the wrist orthosis is to reduce pain, risk of overload of the fracture and to facilitate the use of the hand. The wrist orthosis referred in this study is two different prefabricated (of the shelf) types; a semi-rigid orthosis in elastic fabric with a volar splint or a short elastic wrist orthosis without a splint. Both meant to be worn when the person use the hand in everyday occupation. These wrist orthosis is commonly used in Sweden.

There is a lack research of this kind of wrist orthosis after cast removal for persons with DRF. There are studies of passive treatment orthosis designed to increase movement of the wrist or to reduce pain. Those orthosis is not meant to be worn in everyday occupation. There is however support in research that semi-rigid wrist orthosis i beneficial for persons with rheumatoid arthritis.

Method:

The study has a mixed method design, with a initial quantitative phase with data collection and analysis followed by a qualitative phase with interviews of a sample of the study participants.

After trauma and initial care the person with DRF comes to the hospital for a one week check with/without X-ray. At this point written study information is given to persons meeting the inclusion criteria.

At four weeks after trauma the person with DRF visit an OT to get plaster removal. Treatment as usual (TAU) is given. Then an assessment is made and if the patient meet the inclusion criteria and wish to participate in the study a written informed consent will be obtained. Mobility of the wrist in extension and flexion is measured. The participant is provided with a wrist orthosis and the ordination to use it when needed, where need is described as reducing pain, facilitation of the use of the hand or improved rest för the wrist. A diary and instruction on registration is given. It's to be done approximately one week from cast removal.

At six weeks after trauma a revisit is made. TAU together with collection of the diary. Also there is data collection with patient rated wrist evaluation (PRWE) and measurement of wrist mobility. Information of planned follow-up at Three months after trauma.

At ten weeks after trauma a letter is sent to the participant with a diary and PRWE. The participant is asked to fill in these and bring them to the clinic at revisit.

At twelve weeks after trauma a revisit to the clinic is made. At the visit measure of mobility of the wrist is taken and the diary and PRWE is collected.

At twelve to fourteen weeks after trauma a semi-structured qualitative interview is conducted for a smaller sample of participants. The question areas is about the use and meaning of wrist orthosis in everyday occupation during the time from cast removal till now for the participant.

The following quantitative data will be collected:

  • Demographic data: gender, age, fracture site in dominant or not-dominant hand, if the fracture was undisplaced or replaced, amount of energy in violence responsible for the fracture and number of days in plaster. Also professional activity and days of sick-leave and days before return to work.
  • Mobility of the wrist in extension and flexion, measured with goniometer.
  • The use and benefit of the wrist orthosis is measured with a diary, which is filled in at 5-6 weeks and 10-11 weeks after trauma. It gives data of time with and without wrist orthosis, in which types of occupation wrist orthosis was used and what benefit was experienced.
  • Pain and ability to use the affected hand is measured with PRWE.

Qualitative data is collected through semistructured interviews with a smaller sample of participants. The main question will be: "What significance has the wrist orthosis had for you during the time from plaster removal to today?" During the interview the persons diaries is used as a background for reflection.

Inclusions criteria:

Adult with unilateral distal radius fracture treated conservative with plaster for 25-31 days treated at Alingsås hospital and given plaster removal and rehabilitation by occupational therapist in hospital care or primary care in Alingsås.

Exclusion criteria:

  • At plaster removal no pain in the wrist and less than 20 degrees decrease of mobility in the wrist in extension/flexion/pronation/supination since they are not deemed to be in need of wrist orthosis.
  • Other disease which highly affect pain, joint mobility and/or strength such as rheumatoid arthritis, severe arthritis or neurological disease.
  • Not able to communicate in Swedish
  • Obvious cognitive impairment

Sample size:

In the planned pilot study 30 participants will be enrolled. Interview will be conducted with 6-10 participants.

Being tested
Wrist orthosis
Keywords
rehabilitation, wrist orthosis, occupational therapy, everyday occupation
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wrist orthosisDevice

    The wrist orthosis referred in this study is two different prefabricated (of the shelf) types; a semi-rigid orthosis in elastic fabric with a volar splint or a short elastic wrist orthosis without a splint. Both ment to be worn when the person use the hand in everyday occupation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time for use of wrist orthosis

    self-reported values of time with wrist orthosis day-time and during night

    Measured: 5-6 weeks after fracture and 12 weeks after fracture

  2. Type of activities with wrist orthosis

    Self-reported values of type of activities with wrist orthosis, activities categorized accordingly to Canadian Occupational Performance Measure

    Measured: 5-6 weeks after fracture and 12 weeks after fracture

  3. Perceived usefulness and value of wrist orthosis in different activities

    self-reported value of usefulness/value in different activities

    Measured: 5-6 weeks after fracture and 12 weeks after fracture

Secondary outcomes (2)
  1. Type of usefulness of the wrist orthosis

    self-reported types of usefulness

    Measured: 5-6 weeks after fracture and 12 weeks after fracture

  2. Type of obstacles of the wrist orthosis

    self-reported types of obstacles of the wrist orthosis

    Measured: 5-6 weeks after fracture and 12 weeks after fracture

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2025
  2. Study start15 Sep 2019
  3. Primary completion11 Apr 2025
  4. Study completion11 Apr 2025

Resources

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
Other
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06942546
Sponsor's protocol ID
257381
Status last verified
Apr 2025
First submitted
10 Nov 2020
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Wrist Fracture and Distal Radius Fracture, run by Göteborg University at 1 site in Sweden.

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 2 inclusion and 3 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 24 Apr 2025. 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 Sweden. 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?

Time for use of wrist orthosis (time frame: 5-6 weeks after fracture and 12 weeks after fracture). The study lists 3 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 24 Apr 2025.

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