Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius

Not Applicable

Recruiting

• Conditions: Distal Radius Fracture

• Registration Number: NCT06931418
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

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 Timeline

• Study Start: 2024-05-22
• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-17
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Region-specific patient reported functional outcome score	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).
Range of motion	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.
Grip strength	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.

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life Measured by SF-12 Chinese (HK) Version	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).
Radiographic outcomes	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.
Incidence of complications	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
Qualitative self-reported compliance	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)

Trial Locations

Locations (1)

Queen Mary Hospital, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong