Comparison of Rehabilitation Intervention, Supported by Telemedicine, With Standard Rehabilitation After Distal Radius Fracture.

Not Applicable

• Conditions: Distal Radius Fracture
• Interventions: Device: Experimental

• Registration Number: NCT05463653
• Lead Sponsor: Hospital Clinico Mutual de Seguridad

Brief Summary

This is a randomized clinical trial of two parallel arms, aiming to compare two rehabilitation interventions: an experimental intervention including telemedicine support and remote monitoring of compliance of usual indicated exercises, versus the usual protocol of indicated exercises supported by printed material (triptych) and without remote monitoring

Detailed Description

Distal radius fracture is a common pathology. The surgical indication is given by the difficulty in obtaining fracture reduction or by the instability of the fracture. The long-term functional prognosis of the wrist depends largely on patients' adherence to the prescribed indications/exercises in the immediate postoperative phase.

This is a randomized clinical trial of two parallel arms, aiming to compare two rehabilitation interventions: an experimental intervention including telemedicine support and remote monitoring of compliance of usual indicated exercises, versus the usual protocol of indicated exercises supported by printed material (triptych) and without remote monitoring.

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-05
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Primary Completion: 2023-07-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

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

Inclusion Criteria

• distal radial fracture (A2 to C3 type according to the Orthopaedic Trauma Association classification system)
• indication for standard rehabilitation post-surgery

Exclusion Criteria

• immediate post-surgery complication
• multiple fractures or severe injuries
• history of bone metabolism condition
• illiterate
• non-Spanish speaking
• mental disorder
• not familiar with electronic devices

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental telemedicine	Experimental	Patient's rehabilitation and compliance with the standard exercices will be guided and monitored through an ad hoc device developed specifically for this trial.
Control	Experimental	Patient's rehabilitation and compliance with the standard exercices will be monitored in the usual manner, at the monthly visits to the physical therapy clinic

Primary Outcome Measures

Name	Time	Method
Change of Patient Related Wrist Evaluation score from Day 28 at Day 56 post ranndomization	Day 56	Patient Related Wrist Evaluation is a 15-item validated scale, range from 0 to 100, where higher scores are worse outcomes
Adherence to prescribed excercise program	Day 56	The digital pad will objectively register adherence to exercises; the control group will self-report their compliance rates with the prescribed exercises

Secondary Outcome Measures

Name	Time	Method
Wrist flexion and extension	Day 28; Day 56	Wrist flexion and extension measured by goniometer
Grip strength	Day 28; Day 56	Grip strength measured by dynamometer

Trial Locations

Locations (1)

Hospital Clinico Mutual de Seguridad; 🇨🇱 Santiago, Region Metropolitana, Chile