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Clinical Trials/NCT05463653
NCT05463653
Unknown
N/A

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

Hospital Clinico Mutual de Seguridad1 site in 1 country50 target enrollmentJuly 5, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Distal Radius Fracture
Sponsor
Hospital Clinico Mutual de Seguridad
Enrollment
50
Locations
1
Primary Endpoint
Change of Patient Related Wrist Evaluation score from Day 28 at Day 56 post ranndomization
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 5, 2022
End Date
September 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Clinico Mutual de Seguridad
Responsible Party
Principal Investigator
Principal Investigator

Felipe Andrés Correa Salazar

Physical therapist

Hospital Clinico Mutual de Seguridad

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

Outcomes

Primary Outcomes

Change of Patient Related Wrist Evaluation score from Day 28 at Day 56 post ranndomization

Time Frame: Day 56

Patient Related Wrist Evaluation is a 15-item validated scale, range from 0 to 100, where higher scores are worse outcomes

Adherence to prescribed excercise program

Time Frame: Day 56

The digital pad will objectively register adherence to exercises; the control group will self-report their compliance rates with the prescribed exercises

Secondary Outcomes

  • Wrist flexion and extension(Day 28; Day 56)
  • Grip strength(Day 28; Day 56)

Study Sites (1)

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