NCT03498859

Brief Summary

This study investigates the efficacy of physiotherapist-supervised training once per week during 10 weeks compared to home-based training during 10 weeks, after proksimal humerus fracture.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

April 3, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

January 5, 2023

Status Verified

December 1, 2022

Enrollment Period

3.8 years

First QC Date

April 3, 2018

Last Update Submit

January 4, 2023

Conditions

Proximal Humeral Fracture

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • The Disability of the Arm, Shoulder and Hand (DASH)

    Patient reported outcome measure of physical function in the upper extremity. Measures on a 0-100 scale, where a higher score indicates greater disability. The scores will be compared between the 2 groups

    Measured at 3 months after fracture

Secondary Outcomes (6)

  • The Disability of the Arm, Shoulder and Hand (DASH)

    Measured at baseline and after 12 months

  • Constant Murley Shoulder Score

    Measured after 3 and 12 months.

  • 15-dimentional health-realted quality of life instrument (15D)

    Measured at baseline, after 3 and 12 months

  • Pain catastrophizing Scale

    Measured at baseline, after 3 and 12 months

  • Generel Self-Efficacy scale

    Measured at baseline, after 3 and 12 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • Follow up of the decliners

    Measured at baseline and 3 months

  • Cost-effectiveness

    After 12 months

Study Arms (2)

Home-based training

OTHER

10 weeks of home-based training with no supervision of a physiotherapist

Other: Home-based training

Physiotherapist-supervised training

OTHER

Physiotherapist-supervised training once per week during 10 weeks in addition to home-based training

Other: Physiotherapist-supervised training

Interventions

Physiotherapist-supervised trainingOTHER

The intervention is physiotherapist-supervised training once per week during 10 weeks.

Physiotherapist-supervised training
Home-based trainingOTHER

The intervention is home-based training during 10 weeks

Home-based training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low energy proximal humeral displaced (more than 5mm or 30 degrees) two-part fracture where fracture line emerges through the surgical (or anatomical) neck, treated non-operatively

You may not qualify if:

  • Refuse to participate in the study
  • Younger than 60 years old
  • Non-independent
  • Demented
  • Does no understand written and spoken guidance in local language
  • Pathological fracture or previous fracture in the same proximal humerus
  • Other operational injuries in the same upper limb
  • Major nerve injury (e.g. Complete radialis- or delta palsy)
  • Open fracture
  • Multi-trauma patient
  • Fracture dislocation or head splitting fracture
  • Undisplaced fracture
  • Isolated tuberculum fracture
  • Fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)
  • Treating surgeon considers patient unsuitable to attend the study on medical basis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Viborg Regional Hospital

Viborg, 8800, Denmark

Location

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

  • Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

    PMID: 35727196DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 17, 2018

Study Start

April 24, 2018

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

January 5, 2023

Record last verified: 2022-12

Locations

DK(1)NO(1)