Distal Radius FractureNCT05463653
Comparison of Rehabilitation Intervention, Supported by Telemedicine, With Standard Rehabilitation After Distal Radius Fracture.
A study testing Experimental in people with Distal Radius Fracture, run by Hospital Clinico Mutual de Seguridad at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 5 Jul 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- distal radial fracture (A2 to C3 type according to the Orthopaedic Trauma Association classification system)
- indication for standard rehabilitation post-surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clinico Mutual de Seguridad
Santiago, Santiago Metropolitan
Felipe Correa, felipecorreas@gmail.com
About this study
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
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
Read the 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.
- Conditions
- Distal Radius Fracture
- Being tested
- Experimental
- Keywords
- Rehabilitation, Information technologies
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDevice
A digital pad developed to help, support and monitor the adherence of patients to rehabilitation excercices post surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 56
Secondary outcomes (2)
Grip strength
Grip strength measured by dynamometer
Measured: Day 28; Day 56
Wrist flexion and extension
Wrist flexion and extension measured by goniometer
Measured: Day 28; Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start5 Jul 2022
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms parallel design, randomized assignment, outcomes-assessor blind to the assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Mutual de Seguridad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Andrés Correa Salazar, Hospital Clinico Mutual de Seguridad
- Investigators
- Ricardo Gamboa, Study director, Mutual de Seguridad General Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463653
- Sponsor's protocol ID
- 01
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05463653
- Acronym / sponsor ID
- 01
- Conditions
- Distal Radius Fracture
- Keywords
- Rehabilitation, Information technologies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Clinico Mutual de SeguridadUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms parallel design, randomized assignment, outcomes-assessor blind to the assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental telemedicine | Experimental | Device: ExperimentalPatient's rehabilitation and compliance with the standard exercices will be guided and monitored through an ad hoc device developed specifically for this trial. |
| Control | Active comparator | Device: ExperimentalPatient's rehabilitation and compliance with the standard exercices will be monitored in the usual manner, at the monthly visits to the physical therapy clinic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- distal radial fracture (A2 to C3 type according to the Orthopaedic Trauma Association classification system)
- indication for standard rehabilitation post-surgery
Key exclusion criteria (7 listed)
- immediate post-surgery complication
- multiple fractures or severe injuries
- history of bone metabolism condition
- illiterate
- non-Spanish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalA digital pad developed to help, support and monitor the adherence of patients to rehabilitation excercices post surgery | Device | Control, Experimental telemedicine |
Primary outcome
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
2 secondary outcomes
Grip strength
Time frame: Day 28; Day 56
Wrist flexion and extension
Time frame: Day 28; Day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Gamboa study director
Mutual de Seguridad General Manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Distal Radius Fracture, run by Hospital Clinico Mutual de Seguridad at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felipe S Correa (+56973071601, felipecorreas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Patient Related Wrist Evaluation score from Day 28 at Day 56 post ranndomization (time frame: Day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.