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

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Efficacy of an Early Rehabilitation Intervention, Supported by Telemedicine, Compared to the Usual Rehabilitation Intervention, in Patients With Distal Radius Fracture. Randomized Clinical Trial

Conditions
-----------------
Distal Radius Fracture

Intervention / Treatment
-----------------
* Device: Experimental


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms parallel design, randomized assignment, outcomes-assessor blind to the assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental telemedicine<br>Patient's rehabilitation and compliance with the standard exercices will be guided and monitored through an ad hoc device developed specifically for this trial. | Device: Experimental<br>* A digital pad developed to help, support and monitor the adherence of patients to rehabilitation excercices post surgery<br>|
| Active Comparator: Control<br>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 | Device: Experimental<br>* A digital pad developed to help, support and monitor the adherence of patients to rehabilitation excercices post surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Grip strength measured by dynamometer | Day 28; Day 56 | 
| Wrist flexion and extension | Wrist flexion and extension measured by goniometer | Day 28; Day 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Information technologies