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

NCT ID: NCT05463653

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distal Radius Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arms parallel design, randomized assignment, outcomes-assessor blind to the assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor is a physical therapist independent of the research team, who is blind to the treatment assignment

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Experimental

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Experimental

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Clinico Mutual de Seguridad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Felipe Andrés Correa Salazar

Physical therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ricardo Gamboa

Role: STUDY_DIRECTOR

Mutual de Seguridad General Manager

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Clinico Mutual de Seguridad

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Chile

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Felipe S Correa

Role: CONTACT

+56973071601

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Felipe Correa

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.