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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change of Patient Related Wrist Evaluation score from Day 28 at Day 56 post ranndomization
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcomes assessor is a physical therapist independent of the research team, who is blind to the treatment assignment
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Felipe Andrés Correa Salazar
Physical therapist
Hospital Clinico Mutual de Seguridad