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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Distal Radius Fracture

Treatments: Other: Early Motion Protocol; Other: Early Strengthening Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06931418

UW 24-153

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Early Strengthening Protocol (ESP)

Experimental group

Description:

Early use of strength and passive stretching will be encouraged after their initial assessment by rehabilitation therapists within 2 weeks of their discharge.

Treatment:

Other: Early Strengthening Protocol

Early Motion Protocol (Control)

Active Comparator group

Description:

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.

Treatment:

Other: Early Motion Protocol