NCT06005857

Brief Summary

The aim of this study is to evaluate the difference between the use of paper- versus application-based (smartphone application) exercises in the rehabilitation of intra-articular fractures of the distal radius at the Cantonal Hospital of Fribourg, Switzerland. The operation itself will proceed as usual. However, the rehabilitation will be aided by exercises based either on a paper support or on a digital application (smartphone application), in addition to follow-up by a hand therapist. The aim is to determine which support provides the best improvement in wrist mobility and function, and to speed up the return to work.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

August 9, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 23, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

August 9, 2023

Last Update Submit

April 22, 2024

Conditions

Keywords

distal radius fracturesmartphone applicationpost-operative rehabilitationopen reduction and internal fixationrange of motion

Outcome Measures

Primary Outcomes (1)

  • Range of motion in flexion-extension

    Measurement (in degrees) of joint mobility using a goniometer

    From enrollment to the end of treatment at 3 months

Secondary Outcomes (1)

  • Wrist fonction score

    From enrollment to the end of treatment at 3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The group will receive standard hand therapy program + rehabilitation program sustained by the use of a digital application.

Other: Standard hand therapy + home digital application-based exercises

Control group

ACTIVE COMPARATOR

The control group will receive a standard hand therapy program + paper-based (standard) rehabilitation program.

Other: standard hand therapy + home paper-based exercises

Interventions

Standard post-operative hand rehabilitation and home digital application-based exercises

Experimental group

Standard post-operative hand rehabilitation and home paper-based exercises

Control group

Eligibility Criteria

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

You may qualify if:

  • Complete intra-articular DRF (classification AO 23 C1, C2 or C3)
  • Simple palmar operative approach
  • Simple palmar plate fixation
  • Age 18-65 years
  • Worker
  • Own either a smartphone or other wireless device
  • Consent form signed
  • French or German speaker

You may not qualify if:

  • Extra-articular or partial-articular DRF
  • Double/triple operative approaches needed
  • Bilateral procedure
  • Fracture aged than more of 2 weeks
  • Patient refusal/no informed consent
  • Inability to give informed consent
  • Previous wrist injury or surgery
  • Rheumatoid polyarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HFR Fribourg

Fribourg, 1708, Switzerland

RECRUITING

Related Publications (14)

  • Lu C, Hu Y, Xie J, Fu Q, Leigh I, Governor S, Wang G. The Use of Mobile Health Applications to Improve Patient Experience: Cross-Sectional Study in Chinese Public Hospitals. JMIR Mhealth Uhealth. 2018 May 23;6(5):e126. doi: 10.2196/mhealth.9145.

    PMID: 29792290BACKGROUND
  • Valdes K, Gendernalik E, Hauser J, Tipton M. Use of mobile applications in hand therapy. J Hand Ther. 2020 Apr-Jun;33(2):229-234. doi: 10.1016/j.jht.2019.10.003. Epub 2020 Apr 3.

    PMID: 32253058BACKGROUND
  • Murfin M. Know your apps: an evidence-based approach to evaluation of mobile clinical applications. J Physician Assist Educ. 2013;24(3):38-40. doi: 10.1097/01367895-201324030-00008.

    PMID: 24261171BACKGROUND
  • Wallace S, Clark M, White J. 'It's on my iPhone': attitudes to the use of mobile computing devices in medical education, a mixed-methods study. BMJ Open. 2012 Aug 24;2(4):e001099. doi: 10.1136/bmjopen-2012-001099. Print 2012.

    PMID: 22923627BACKGROUND
  • Lyngcoln A, Taylor N, Pizzari T, Baskus K. The relationship between adherence to hand therapy and short-term outcome after distal radius fracture. J Hand Ther. 2005 Jan-Mar;18(1):2-8; quiz 9. doi: 10.1197/j.jht.2004.10.008.

    PMID: 15674780BACKGROUND
  • Wakefield AE, McQueen MM. The role of physiotherapy and clinical predictors of outcome after fracture of the distal radius. J Bone Joint Surg Br. 2000 Sep;82(7):972-6. doi: 10.1302/0301-620x.82b7.10377.

    PMID: 11041584BACKGROUND
  • Brehmer JL, Husband JB. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study. J Bone Joint Surg Am. 2014 Oct 1;96(19):1621-30. doi: 10.2106/JBJS.M.00860.

    PMID: 25274787BACKGROUND
  • Kay S, McMahon M, Stiller K. An advice and exercise program has some benefits over natural recovery after distal radius fracture: a randomised trial. Aust J Physiother. 2008;54(4):253-9. doi: 10.1016/s0004-9514(08)70004-7.

    PMID: 19025505BACKGROUND
  • Christensen OM, Kunov A, Hansen FF, Christiansen TC, Krasheninnikoff M. Occupational therapy and Colles' fractures. Int Orthop. 2001;25(1):43-5. doi: 10.1007/s002640000183.

    PMID: 11374267BACKGROUND
  • Ezzat A, Baliga S, Carnegie C, Johnstone A. Volar locking plate fixation for distal radius fractures: Does age affect outcome? J Orthop. 2016 Feb 22;13(2):76-80. doi: 10.1016/j.jor.2016.01.001. eCollection 2016 Jun.

    PMID: 27053837BACKGROUND
  • Mattila VM, Huttunen TT, Sillanpaa P, Niemi S, Pihlajamaki H, Kannus P. Significant change in the surgical treatment of distal radius fractures: a nationwide study between 1998 and 2008 in Finland. J Trauma. 2011 Oct;71(4):939-42; discussion 942-3. doi: 10.1097/TA.0b013e3182231af9.

    PMID: 21986738BACKGROUND
  • Al Khudairy A, Hirpara KM, Kelly IP, Quinlan JF. Conservative treatment of the distal radius fracture using thermoplastic splint: pilot study results. Eur J Orthop Surg Traumatol. 2013 Aug;23(6):647-50. doi: 10.1007/s00590-012-1042-8. Epub 2012 Jul 14.

    PMID: 23412175BACKGROUND
  • Jerrhag D, Englund M, Karlsson MK, Rosengren BE. Epidemiology and time trends of distal forearm fractures in adults - a study of 11.2 million person-years in Sweden. BMC Musculoskelet Disord. 2017 Jun 2;18(1):240. doi: 10.1186/s12891-017-1596-z.

    PMID: 28576135BACKGROUND
  • Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.

    PMID: 16814787BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Thomas TM Mészaros, MD

    HFR Fribourg, Hôpital Cantonal

    STUDY DIRECTOR

Central Study Contacts

Thomas TM Mészaros, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 23, 2023

Study Start

January 23, 2024

Primary Completion

March 15, 2024

Study Completion

June 30, 2025

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Data will be secured and anonymized, and analyzed only by the principal investigator.

Locations