Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorThe University of Hong Kong

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early Strengthening Protocol

    Other intervention

    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.

  • Early Motion Protocol

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Early Strengthening Protocol (ESP)Experimental treatment 1 intervention
Group B: Early Motion Protocol (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Region-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
2

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
3

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

Secondary outcomes

1

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
2

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
3

Incidence of complications

Incidence of wound breakdown, infection, CRPS, implant failure including screw breakage, and re-operation

Time frame
At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
4

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

Other outcomes

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