NCT06942546

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

5.6 years

First QC Date

November 10, 2020

Last Update Submit

April 16, 2025

Conditions

Keywords

rehabilitationwrist orthosisoccupational therapyeveryday occupation

Outcome Measures

Primary Outcomes (3)

  • Time for use of wrist orthosis

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

    5-6 weeks after fracture and 12 weeks after fracture

  • Type of activities with wrist orthosis

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

    5-6 weeks after fracture and 12 weeks after fracture

  • Perceived usefulness and value of wrist orthosis in different activities

    self-reported value of usefulness/value in different activities

    5-6 weeks after fracture and 12 weeks after fracture

Secondary Outcomes (2)

  • Type of usefulness of the wrist orthosis

    5-6 weeks after fracture and 12 weeks after fracture

  • Type of obstacles of the wrist orthosis

    5-6 weeks after fracture and 12 weeks after fracture

Other Outcomes (1)

  • qualitative data of the experiences of usage of wrist orthosis the first time after wrist fracture

    at 12-14 weeks after fracture

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sjukhusen i väster Rehabmottagning Alingsås

Alingsås, 44183, Sweden

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

April 24, 2025

Study Start

September 15, 2019

Primary Completion

April 11, 2025

Study Completion

April 11, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Locations