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

NCT05463653 | Unknown

• 1 other identifier: 01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Distal Radius Fracture

Keywords

Rehabilitation; Information technologies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Grip strength

  Day 28; Day 56

• Wrist flexion and extension

  Day 28; Day 56

Study Arms (2)

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.

Device: Experimental

Control

ACTIVE COMPARATOR

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

Interventions

Experimental DEVICE

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

Control; Experimental telemedicine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinico Mutual de Seguridad: lead

Study Sites (1)

Hospital Clinico Mutual de Seguridad

Santiago, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Ricardo Gamboa

  Mutual de Seguridad General Manager

  STUDY DIRECTOR

Central Study Contacts

Felipe S Correa

CONTACT

+56973071601; felipecorreas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is a physical therapist independent of the research team, who is blind to the treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Model Details: Two arms parallel design, randomized assignment, outcomes-assessor blind to the assignment

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 19, 2022
• Study Start: July 5, 2022
• Primary Completion: July 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)