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

Distal Radius Fracture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463653
• Other study ID #: 01
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2022
• Source: Hospital Clinico Mutual de Seguridad
• Contact: Felipe S Correa
• Phone: +56973071601
• Email: felipecorreas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Device:
• Experimental
A digital pad developed to help, support and monitor the adherence of patients to rehabilitation excercices post surgery

Locations

Country	Name	City	State
Chile	Hospital Clinico Mutual de Seguridad	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Mutual de Seguridad

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Grip strength	Grip strength measured by dynamometer	Day 28; Day 56
Secondary	Wrist flexion and extension	Wrist flexion and extension measured by goniometer	Day 28; Day 56