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

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

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 Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Device: Experimental

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felipe S Correa; Phone Number: +56973071601; Email: felipecorreas@gmail.com

Study Locations

• Chile
  • Region Metropolitana
    • Santiago, Region Metropolitana, Chile
      • Recruiting
      • Hospital Clinico Mutual de Seguridad
      • Contact: Felipe Correa; Email: felipecorreas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental telemedicine; 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; A digital pad developed to help, support and monitor the adherence of patients to rehabilitation excercices post surgery
Active Comparator: Control; 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; A digital pad developed to help, support and monitor the adherence of patients to rehabilitation excercices post surgery

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

Collaborators and Investigators

• Sponsor: Hospital Clinico Mutual de Seguridad
• Investigators: Study Director: Ricardo Gamboa, Mutual de Seguridad General Manager

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Information technologies
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No