Wrist FracturesNCT06698367
Unilateral Training of the Uninjured Limb on Clinical Outcomes in Patients with Surgically Treated Radius Fracture
A study testing Standard rehabilitation, Unilateral high-intensity strength exercise and Unilateral mobility exercises in people with Wrist Fractures and Distal Radius Fractures, run by Universidad Catolica de Temuco at 1 site in Chile.
Trial summary
The objective will be to determine the effectiveness of adding unilateral upper limb postoperative training to standard rehabilitation compared to standard rehabilitation on maximum grip strength and manual dexterity in patients aged 30-50 years with surgically treated distal radius fracture. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Wrist Fractures, Distal Radius Fractures
- What is being tested?
- Standard rehabilitation, Unilateral high-intensity strength exercise and Unilateral mobility exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChile
- Study dates
- Jan 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 30-50 years
- Radiological diagnosis of unilateral distal radius fracture without concomitant fractures.
- Fracture treated surgically.
Who cannot join
- Patients with lesion of the triangular fibrocartilage.
- Patients with distal radius fracture with consolidation disorders.
- Patients with health conditions that cause pain or affect the motor skills of the upper limb (radiocarpal osteoarthritis, carpal tunnel syndrome, Quervain's tenosynovitis, neurodegenerative diseases, sequelae of stroke)
- Patients with multi-site pain or chronic polyarticular diseases such as osteoarthritis or rheumatoid arthritis.
- Unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow high-intensity physical exercise.
- Patients who are taking nutritional supplements that interfere with the regulation of skeletal muscle strength and mass (example: whey protein, creatine, etc.)
- Inability to understand, read and/or speak the Spanish language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Red Salud
Temuco, Temuco
Iván Cuyul Vásquez, 56990914987, ivancuyul@gmail.com
About this study
Official title: Addition of Unilateral Training of the Uninjured Limb to Standard Rehabilitation on Grip Strength and Manual Dexterity of Patients with Surgically Treated Distal Radius Fracture.
The objective will be to determine the effectiveness of adding unilateral upper limb postoperative training to standard rehabilitation compared to standard rehabilitation on maximum grip strength and manual dexterity in patients aged 30-50 years with surgically treated distal radius fracture. It is presumed that the addition of unilateral upper limb training will significantly improve maximum grip strength and manual dexterity at the end of the intervention period compared to the group receiving only standard rehabilitation.
Patients who agree to participate in this research will be randomly assigned to a control group (standard rehabilitation with unilateral training with mobility exercises) or an experimental group (standard rehabilitation with unilateral high-intensity strength training). The duration of the postoperative intervention will be 12 weeks. The primary variables are maximum grip strength and manual dexterity. Secondary variables are wrist mobility, forearm circumference, maximum voluntary isometric strength, functionality and health-related quality of life. Results will be measured at 0, 6 and 12 weeks postoperative.
- Conditions
- Wrist Fractures, Distal Radius Fractures
- Being tested
- Standard rehabilitation, Unilateral high-intensity strength exercise, Unilateral mobility exercises
- Keywords
- Distal radius fracture, Cross-education, Rehabilitation, Exercise
- Medical subject headings
- Wrist Fractures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard rehabilitationOther
Protocol based on the best available evidence and to be used in all participants in both groups. The standard rehabilitation protocol will consist of three postoperative phases: Mobilization (0 to 4 weeks), Strengthening (4 to 8 weeks) and Functional phase (8 to 12 weeks). Sessions will be held 3 times a week for 12 weeks. Each session will last 1 hour and will consist of different modalities of therapeutic exercise and cryotherapy.
Unilateral high-intensity strength exerciseOther
Participants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an eccentric exercise for the pronosupinator muscles with a dumbbell with adjustable weights. The training will start with an intensity of 60% of 1RM, until reaching 80% 1RM.
Unilateral mobility exercisesOther
Participants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an active mobility exercise for the pronation-supination muscles using a plastic rod.
| Study group | Role | What they receive |
|---|---|---|
| Standard rehabilitation plus unilateral high-intensity strength exercise | Experimental | Participants will undergo progressive strength training based on eccentric contractions during the mobilization and strengthening phases of standard rehabilitation. Receives: Other: Standard rehabilitation; Other: Unilateral high-intensity strength exercise |
| Standard rehabilitation plus unilateral mobility exercises | Active comparator | Participants will undergo active mobility training of the pronation-supination movements during the mobilization and strengthening phases of standard rehabilitation Receives: Other: Standard rehabilitation; Other: Unilateral mobility exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength
Jamar grip dynamometer (kilos)
Measured: 0, 6 and 12 weeks
Manual dexterity
Functional Dexterity Test (Seconds)
Measured: 0, 6 and 12 weeks
Secondary outcomes (7)
Active range motion
Wrist and forearm: Extension, flexion, pronation and supination (degree)
Measured: 0, 6 and 12 weeks
Pain intensity
Visual Analogue Scale (0-10 centimeters)
Measured: 0, 6 and 12 weeks
Forearm circumference
Circumference (cm)
Measured: 0, 6 and 12 weeks
Maximum voluntary isometric strength.
Progressor 300, Tindeq, Norway (Kilos)
Measured: 0, 6 and 12 weeks
Self-reported upper limb function.
Quick Disabilities of Arm, Shoulder and Hand (0-100 points)
Measured: 0, 6 and 12 weeks
Self-reported wrist function
Patient-Rated Wrist Evaluation (0-50 points)
Measured: 0, 6 and 12 weeks
Health-related quality of life
Short Form-12 (0-100 points)
Measured: 0, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist FracturesStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Catolica de Temuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iván Alejandro Cuyul Vásquez, Universidad Catolica de Temuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698367
- Sponsor's protocol ID
- RCT-EdCruzada2024
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 3 Dec 2024
- 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Unilateral Training of the Uninjured Limb to Standard Rehabilitation on Grip Strength and Manual Dexterity of Patients with Surgically Treated Distal Radius Fracture.
- ClinicalTrials.gov ID
- NCT06698367
- Acronym / sponsor ID
- RCT-EdCruzada2024
- Conditions
- Wrist Fractures, Distal Radius Fractures
- Keywords
- Distal radius fracture, Cross-education, Rehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Universidad Catolica de TemucoUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Nov 2024 (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.
The objective will be to determine the effectiveness of adding unilateral upper limb postoperative training to standard rehabilitation compared to standard rehabilitation on maximum grip strength and manual dexterity in patients aged 30-50 years with surgically treated distal radius fracture. It is presumed that the addition of unilateral upper limb training will significantly improve maximum grip strength and manual dexterity at the end of the intervention period compared to the group receiving only standard rehabilitation.
Patients who agree to participate in this research will be randomly assigned to a control group (standard rehabilitation with unilateral training with mobility exercises) or an experimental group (standard rehabilitation with unilateral high-intensity strength training). The duration of the postoperative intervention will be 12 weeks. The primary variables are maximum grip strength and manual dexterity. Secondary variables are wrist mobility, forearm circumference, maximum voluntary isometric strength, functionality and health-related quality of life. Results will be measured at 0, 6 and 12 weeks postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation plus unilateral high-intensity strength exercise | Experimental | Other: Standard rehabilitation, Other: Unilateral high-intensity strength exerciseParticipants will undergo progressive strength training based on eccentric contractions during the mobilization and strengthening phases of standard rehabilitation. |
| Standard rehabilitation plus unilateral mobility exercises | Active comparator | Other: Standard rehabilitation, Other: Unilateral mobility exercisesParticipants will undergo active mobility training of the pronation-supination movements during the mobilization and strengthening phases of standard rehabilitation |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 30-50 years
- Radiological diagnosis of unilateral distal radius fracture without concomitant fractures.
- Fracture treated surgically.
Key exclusion criteria (7 listed)
- Patients with lesion of the triangular fibrocartilage.
- Patients with distal radius fracture with consolidation disorders.
- Patients with health conditions that cause pain or affect the motor skills of the upper limb (radiocarpal osteoarthritis, carpal tunnel syndrome, Quervain's tenosynovitis, neurodegenerative diseases, sequelae of stroke)
- Patients with multi-site pain or chronic polyarticular diseases such as osteoarthritis or rheumatoid arthritis.
- Unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow high-intensity physical exercise.
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 |
|---|---|---|
| Standard rehabilitationProtocol based on the best available evidence and to be used in all participants in both groups. The standard rehabilitation protocol will consist of three postoperative phases: Mobilization (0 to 4 weeks), Strengthening (4 to 8 weeks) and Functional phase (8 to 12 weeks). Sessions will be held 3 times a week for 12 weeks. Each session will last 1 hour and will consist of different modalities of therapeutic exercise and cryotherapy. | Other | Standard rehabilitation plus unilateral high-intensity strength exercise, Standard rehabilitation plus unilateral mobility exercises |
| Unilateral high-intensity strength exerciseParticipants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an eccentric exercise for the pronosupinator muscles with a dumbbell with adjustable weights. The training will start with an intensity of 60% of 1RM, until reaching 80% 1RM. | Other | Standard rehabilitation plus unilateral high-intensity strength exercise |
| Unilateral mobility exercisesParticipants will be seated in an armchair with armrests and will perform 4 sets of 8 repetitions of an active mobility exercise for the pronation-supination muscles using a plastic rod. | Other | Standard rehabilitation plus unilateral mobility exercises |
Primary outcome
Handgrip strength
Time frame: 0, 6 and 12 weeks
Jamar grip dynamometer (kilos)
Manual dexterity
Time frame: 0, 6 and 12 weeks
Functional Dexterity Test (Seconds)
7 secondary outcomes
Active range motion
Time frame: 0, 6 and 12 weeks
Pain intensity
Time frame: 0, 6 and 12 weeks
Forearm circumference
Time frame: 0, 6 and 12 weeks
Maximum voluntary isometric strength.
Time frame: 0, 6 and 12 weeks
Self-reported upper limb function.
Time frame: 0, 6 and 12 weeks
Self-reported wrist function
Time frame: 0, 6 and 12 weeks
Health-related quality of life
Time frame: 0, 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard rehabilitation, Unilateral high-intensity strength exercise and Unilateral mobility exercises in people with Wrist Fractures and Distal Radius Fractures, run by Universidad Catolica de Temuco 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 3 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: opening soon, as of the sponsor's last update on 3 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iván Cuyul Vásquez (56990914987, ivancuyul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip strength (time frame: 0, 6 and 12 weeks). 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 3 Dec 2024.