Comparison of Rehabilitation Intervention, Supported by Telemedicine, With Standard Rehabilitation After Distal Radius Fracture.
Primary Purpose
Distal Radius Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Experimental
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture focused on measuring Rehabilitation, Information technologies
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
Sites / Locations
- Hospital Clinico Mutual de SeguridadRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental telemedicine
Control
Arm Description
Patient's rehabilitation and compliance with the standard exercices will be guided and monitored through an ad hoc device developed specifically for this trial.
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
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Grip strength
Grip strength measured by dynamometer
Wrist flexion and extension
Wrist flexion and extension measured by goniometer
Full Information
NCT ID
NCT05463653
First Posted
July 13, 2022
Last Updated
July 14, 2022
Sponsor
Hospital Clinico Mutual de Seguridad
1. Study Identification
Unique Protocol Identification Number
NCT05463653
Brief Title
Comparison of Rehabilitation Intervention, Supported by Telemedicine, With Standard Rehabilitation After Distal Radius Fracture.
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinico Mutual de Seguridad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Rehabilitation, Information technologies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arms parallel design, randomized assignment, outcomes-assessor blind to the assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor is a physical therapist independent of the research team, who is blind to the treatment assignment
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental telemedicine
Arm Type
Experimental
Arm Description
Patient's rehabilitation and compliance with the standard exercices will be guided and monitored through an ad hoc device developed specifically for this trial.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Experimental
Intervention Description
A digital pad developed to help, support and monitor the adherence of patients to rehabilitation excercices post surgery
Primary Outcome Measure Information:
Title
Change of Patient Related Wrist Evaluation score from Day 28 at Day 56 post ranndomization
Description
Patient Related Wrist Evaluation is a 15-item validated scale, range from 0 to 100, where higher scores are worse outcomes
Time Frame
Day 56
Title
Adherence to prescribed excercise program
Description
The digital pad will objectively register adherence to exercises; the control group will self-report their compliance rates with the prescribed exercises
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Grip strength
Description
Grip strength measured by dynamometer
Time Frame
Day 28; Day 56
Title
Wrist flexion and extension
Description
Wrist flexion and extension measured by goniometer
Time Frame
Day 28; Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felipe S Correa
Phone
+56973071601
Email
felipecorreas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Gamboa
Organizational Affiliation
Mutual de Seguridad General Manager
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clinico Mutual de Seguridad
City
Santiago
State/Province
Region Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Correa
Email
felipecorreas@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Rehabilitation Intervention, Supported by Telemedicine, With Standard Rehabilitation After Distal Radius Fracture.
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