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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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.
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.
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGRegion-specific patient reported functional outcome score
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).
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Range of motion
Subjects' wrist range of motion, including: pronation, supination, flexion, and extension will be measured by allied health therapists at each follow-up timepoint.
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Grip strength
Grip strength will be measured using a dynamometer weekly for the ESP group and weekly from 6 weeks onwards for the EMP group.
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
Health-related Quality of Life Measured by SF-12 Chinese (HK) Version
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).
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Radiographic outcomes
Subjects' X-rays will be assessed for fracture healing, implant migration, and fracture displacement.
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Incidence of complications
Incidence of wound breakdown, infection, CRPS, implant failure including screw breakage, and re-operation
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Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Qualitative self-reported compliance
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)
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months