Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius (EMPRESS)

April 22, 2025 updated by: Prof. Christian Xinshuo Fang, The University of Hong Kong

Randomized Controlled Trial for Post-operative Fracture Distal Radius Rehabilitation - The Early Motion Protocol Rehabilitation vs. Early Strengthening Study (EMPRESS Trial)

The primary objective of this study is to demonstrate safety and efficacy of an early strengthening and passive mobilization rehabilitation program for post-operative distal radius fracture fixation surgery compared to current conventional rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Functional outcome after distal radius fracture fixation has often been variable with multiple factors affecting final results. Early mobilization rehabilitation protocols have been the gold standard after fracture fixation surgery. Rehabilitation protocols vary from center to center's own practices. However, these commonly encompass an early mobilization protocol or otherwise known as accelerated rehabilitation or enhanced recovery after surgery (ERAS) programs. Such programs comprise of a short duration of immobilization followed by a period of active mobilization before strengthening exercises are employed.

The investigators have performed early motion protocol (EMP) rehabilitation in the last decade in the investigation center for post-operative fracture distal radius fixation patients. The early motion protocol allows immediate active mobilization without a period of immobilization or splint protection. Despite early mobilization rehabilitation, there are a subset of patients who develop significant stiffness and pain with poor functional outcomes, especially in the early post-operative period. Moreover, some patients may also develop complex regional pain syndrome (CRPS) albeit early active mobilization. Thus, an early strengthening protocol (ESP) was developed to allow for immediate strengthening and passive mobilization exercises post-operatively with physiotherapist and occupational therapist guidance. Herein this study, the investigators hope to demonstrate the safety and efficacy of an ESP rehabilitation compared to EMP for post-operative distal radius fracture fixation.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christian Prof. FANG, MBBS(HK)
  • Phone Number: +852 22554581
  • Email: cfang@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital, The University of Hong Kong
        • Contact:
          • Christian Prof. FANG, MBBS(HK)
          • Phone Number: +852 22554581
          • Email: cfang@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 50 years or older
  • Diagnosed with an isolated closed injury, displaced, distal radius fracture (AO/OTA Classification 23-A1-3, B1-2, C1-2) without articular comminution
  • Requires operative fixation
  • Able to give consent

Exclusion Criteria:

  • History of previous hand or wrist surgery
  • Neurological injury or pre-existing neurological conditions to the upper limb
  • Underlying osteoarthritis of the wrist
  • Unfit for surgical anesthesia
  • Subacute fractures with delayed presentation (>2 weeks since initial injury)
  • Unable to consent
  • Refuse surgical intervention
  • Unable to follow commands for rehabilitation
  • Fixation construct or injuries requiring immobilization after surgery, such as unfixed distal ulna head or shaft fractures that require splintage or distal radio-ulnar joint instability planned for immobilization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Strengthening Protocol (ESP)
Early use of strength and passive stretching will be encouraged after their initial assessment by rehabilitation therapists within 2 weeks of their discharge.
Other: Early Strengthening Protocol
Patients in the ESP intervention arm will undergo active and passive exercises as well as strengthening exercises after their initial assessment by rehabilitation therapists within 2 weeks of their discharge. Early use of strength and passive stretching will be encouraged immediately after allocation.
Active Comparator: Early Motion Protocol (Control)
Active mobilization is continued for the initial post-operative 6 weeks with allied health therapists, while passive mobilization and strengthening are started at the post-operative 8-10-week period.
Other: Early Motion Protocol
Patients are instructed for active flexion, extension, supination, pronation and finger flexion of the operated wrist along with motion of the shoulder and elbow after operation. Active mobilization is continued for the initial post-operative 6 weeks with allied health therapists. Passive mobilization and strengthening is started at the post-operative 8-10-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Region-specific patient reported functional outcome score
Time Frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Physical function and symptoms measured by Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), an 11-item patient-reported measure with a total score ranging from 0 (no disability) to 100 (most severe disability).
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Range of motion
Time Frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Subjects' wrist range of motion, including: pronation, supination, flexion, and extension will be measured by allied health therapists at each follow-up timepoint.
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Grip strength
Time Frame: ESP group: At post-op weekly from 1 to 12 weeks, 6 months and 12 months ; EMP group: At post-op weekly from 6 to 12 weeks, 6 months and 12 months
Grip strength will be measured using a dynamometer weekly for the ESP group and weekly from 6 weeks onwards for the EMP group.
ESP group: At post-op weekly from 1 to 12 weeks, 6 months and 12 months ; EMP group: At post-op weekly from 6 to 12 weeks, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life Measured by SF-12 Chinese (HK) Version
Time Frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
12-item Short Form Health Survey (SF-12), a patient-reported outcome measure of HRQOL comprised of a mental component (MCS) and physical component (PCS), each with a final score ranging from 0 (worst outcome) to 100 (best outcome).
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Radiographic outcomes
Time Frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Subjects' X-rays will be assessed for fracture healing, implant migration, and fracture displacement.
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Incidence of complications
Time Frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Incidence of wound breakdown, infection, CRPS, implant failure including screw breakage, and re-operation
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Qualitative self-reported compliance
Time Frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Subjects' self-reported score on their compliance to the rehabilitation exercises based on a Likert Scale of 1 (Did not follow) to 5 (Fully comply)
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Christian Prof. Fang, MBBS(HK), FRCS(Edinburgh), FHK, Dept of Orthopaedics and Traumatology, Queen Mary Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2024

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized dataset to be included as supplementary data in final publication

IPD Sharing Time Frame

Within 1 year of study completion

IPD Sharing Access Criteria

Additional information available upon reasonable request of principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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