Elbow FractureDTelbowNCT05380219
Effects of Dual Task on Physical Function in Patients With Elbow Joint Fracture
A study testing dual task strength training in people with Elbow Fracture, run by University of Valencia at 1 site in Spain.
Trial summary
Elbow injuries account for up to 15% of emergency consultations. The complexity of this joint and the subtle imaging findings present even in severe injuries make diagnosis difficult and can delay treatment, causing pain and functional impotence. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Elbow Fracture
- What is being tested?
- dual task strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jun 2022to 9 Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for this study will be men and women over 18 years of age who have been diagnosed with a fracture of the elbow joint (types 1-3 and types 2-1 according to Müller's OA fracture classification), with or without a surgical approach and with date of injury and completion of their physiotherapy program in 2022-2023, and who begin their physiotherapy treatment between weeks 7 to 9 post-fracture.
- The patients will voluntarily participate in the study, which will be carried out at the Hospital Clínico Universitario de Valencia, during the months of May 2022 to May 2023. All participants will be informed about the objectives and content of the research and information will be obtained. written informed consent. The study will conform to the Declaration of Helsinki and will be approved by the local ethics committee.
Who cannot join
- Participants will be excluded if they have any involvement in the contralateral upper limb, if they have already had/have any other injury to the elbow or other anatomical part of the affected MS (in the last year), and if they have any other condition or disease in the which there is a contraindication to physical exercise. Also if they participate in physiotherapy programs external to the one carried out by us or in other research studies. In addition, if there is evidence of a severe failure in bone consolidation (separation greater than 5 mm), if there is neural injury, CRPS (Complex Regional Pain Syndrome), severe open fracture with muscle and periosteal loss, clinical picture not competent for physiotherapy by diagnosis doubtful and severe congenital instability of MMSS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dual Task During Upper Limb Strengthening on Physical Function and Pain in Patients With Elbow Joint Fracture
Elbow injuries account for up to 15% of emergency consultations. The complexity of this joint and the subtle imaging findings present even in severe injuries make diagnosis difficult and can delay treatment, causing pain and functional impotence.
Appropriate deterioration mitigation strategies include, but are not limited to, strengthening programs of sufficient intensity to stimulate anabolism and limit muscle loss and increase strength. The general recommendation for increasing muscle strength and neural adaptations in healthy subjects after sustaining an elbow fracture is moderate to heavy load resistance training with loads approximating 60%-80% of the one repetition maximum ( 1RM). However, high joint stress would be challenging and increase the risk of adverse consequences in such patients, so strategies are still needed to meet the challenges of effectively and safely adapting training loads to safely enable improvement. without requiring high joint stress.
Read more
Resistance band work, coupled with the use of dual tasks, is a novel approach used during resistance training, especially among healthy populations, with promising results.
The purpose of the study is to evaluate neuromuscular responses, pain intensity and RPE in patients with elbow joint fracture, with or without surgical approach, with different strategies to strengthen the upper limb.
Candidates for this study will be men and women over 18 years of age who have been diagnosed with a fracture of the elbow joint (types 1-3 and types 2-1 according to Müller's OA fracture classification), with or without a surgical approach and with date of injury and completion of their physiotherapy program in 2022-2023, and who begin their physiotherapy treatment between weeks 7 to 9 post-fracture.
Read the detailed description
Elbow injuries account for up to 15% of emergency consultations. The complexity of this joint and the subtle imaging findings present even in severe injuries make diagnosis difficult and can delay treatment, causing pain and functional impotence.
Appropriate deterioration mitigation strategies include, but are not limited to, strengthening programs of sufficient intensity to stimulate anabolism and limit muscle loss and increase strength. The general recommendation for increasing muscle strength and neural adaptations in healthy subjects after sustaining an elbow fracture is moderate to heavy load resistance training with loads approximating 60%-80% of the one repetition maximum ( 1RM). However, high joint stress would be challenging and increase the risk of adverse consequences in such patients, so strategies are still needed to meet the challenges of effectively and safely adapting training loads to safely enable improvement. without requiring high joint stress.
Resistance band work, coupled with the use of dual tasks, is a novel approach used during resistance training, especially among healthy populations, with promising results.
The purpose of the study is to evaluate neuromuscular responses, pain intensity and RPE in patients with elbow joint fracture, with or without surgical approach, with different strategies to strengthen the upper limb.
Candidates for this study will be men and women over 18 years of age who have been diagnosed with a fracture of the elbow joint (types 1-3 and types 2-1 according to Müller's OA fracture classification), with or without a surgical approach and with date of injury and completion of their physiotherapy program in 2022-2023, and who begin their physiotherapy treatment between weeks 7 to 9 post-fracture.
The patients will voluntarily participate in the study, which will be carried out at the Hospital Clínico Universitario de Valencia, during the months of May 2022 to May 2023. All participants will be informed about the objectives and content of the research and information will be obtained. written informed consent. The study will conform to the Declaration of Helsinki and will be approved by the local ethics committee.
Participants will be excluded if they have any involvement in the contralateral upper limb, if they have already had/have any other injury to the elbow or other anatomical part of the affected MS (in the last year), and if they have any other condition or disease in the which there is a contraindication to physical exercise. Also if they participate in physiotherapy programs external to the one carried out by us or in other research studies. In addition, if there is evidence of a severe failure in bone consolidation (separation greater than 5 mm), if there is neural injury, CRPS (Complex Regional Pain Syndrome), severe open fracture with muscle and periosteal loss, clinical picture not competent for physiotherapy by diagnosis doubtful and severe congenital instability of MMSS.
First, an observational session will be held. Patients will then be randomized into 2 groups: one group with strength training and one with strength training and dual task.
- Conditions
- Elbow Fracture
- Being tested
- dual task strength training
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual task strength trainingOther
strength training and dual task
| Study group | Role | What they receive |
|---|---|---|
| dual task strength training | Experimental | The participants of this group will perform their training following the dual task described. Receives: Other: dual task strength training |
| strength training | Active comparator | The participants of this group will perform the work of strengthening the upper limb in a conventional way. Receives: Other: dual task strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric elbow extension/flexion force
They will be evaluated with a portable handheld dynamometer. The tests will be carried out against a fixed resistance: the participants were with their elbows at 90º, in a sitting position with an upright posture, without a backrest and with both feet placed flat on the floor, with force exerted against a fixed table. 3 maximum contractions of 5 seconds will be performed, separated by 1 minute of rest, selecting the average value of these 3 for later analysis.
Measured: 12 weeks
Self-reported pain intensity
The patient marks a point on the scale and subsequently, the clinician or researcher quantifies the number of mm indicated by the patient.Therefore, the self-perceived pain intensity range travels from 0-100 mm. VAS is the most widely used so far in research to assess pain intensity.
higher scores mean a worse outcome
Measured: 12 weeks
Secondary outcomes (3)
Kinesiophobia
Kinesiophobia will be evaluated mainly through the Spanish version of the Kinesiophobia Tampa Scale in a self-recorded manner. This instrument has shown adequate reliability (showing an internal consistency of α=0.79). The total score ranges between 11 and 44 points, with higher levels of kinesiophobia the higher the score obtained on the scale. In addition, kinesiophobia specific to the type of exercise performed will be assessed, with a self-perceived scale from 0 to 10, where patients will indicate the fear of performing all possible repetitions during a strength exercise.
Measured: 12 weeks
Shoulder Disability
It will be evaluated using the DASH questionnaire in Spanish. The assessment of the ability to perform various tasks (open a new or very tight jar, write, turn a key, prepare food, etc.), The score can range between 30 and 150 points. A higher score indicates a higher level of disability and severity, while a lower percentage indicates a low level of disability. This questionnaire has shown adequate reliability (showing an internal consistency of α=0.96).
Measured: 12 weeks
passive range of motion
The degrees of movement (ROM) of the following joints shall be actively and passively measured by means of a manual goniometer: elbow (flexion and extension), forearm (pronation and supination), wrist (flexion and extension), metacarpophalangeal (flexion), proximal intephalangeal (flexion) and distal interphalangeal (flexion).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start5 Jun 2022
- Primary completion9 Oct 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FractureStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura López-Bueno, University of Valencia
- Investigators
- Laura López-Bueno, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380219
- Sponsor's protocol ID
- ID0001
- Acronym
- DTelbow
- Status last verified
- Feb 2024
- First submitted
- 12 May 2022
- Last updated
- 29 Feb 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual Task During Upper Limb Strengthening on Physical Function and Pain in Patients With Elbow Joint Fracture
- ClinicalTrials.gov ID
- NCT05380219
- Acronym / sponsor ID
- DTelbow / ID0001
- Conditions
- Elbow Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 18 May 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.
Elbow injuries account for up to 15% of emergency consultations. The complexity of this joint and the subtle imaging findings present even in severe injuries make diagnosis difficult and can delay treatment, causing pain and functional impotence.
Appropriate deterioration mitigation strategies include, but are not limited to, strengthening programs of sufficient intensity to stimulate anabolism and limit muscle loss and increase strength. The general recommendation for increasing muscle strength and neural adaptations in healthy subjects after sustaining an elbow fracture is moderate to heavy load resistance training with loads approximating 60%-80% of the one repetition maximum ( 1RM). However, high joint stress would be challenging and increase the risk of adverse consequences in such patients, so strategies are still needed to meet the challenges of effectively and safely adapting training loads to safely enable improvement. without requiring high joint stress.
Resistance band work, coupled with the use of dual tasks, is a novel approach used during resistance training, especially among healthy populations, with promising results.
The purpose of the study is to evaluate neuromuscular responses, pain intensity and RPE in patients with elbow joint fracture, with or without surgical approach, with different strategies to strengthen the upper limb.
Candidates for this study will be men and women over 18 years of age who have been diagnosed with a fracture of the elbow joint (types 1-3 and types 2-1 according to Müller's OA fracture classification), with or without a surgical approach and with date of injury and completion of their physiotherapy program in 2022-2023, and who begin their physiotherapy treatment between weeks 7 to 9 post-fracture.
Detailed description
Elbow injuries account for up to 15% of emergency consultations. The complexity of this joint and the subtle imaging findings present even in severe injuries make diagnosis difficult and can delay treatment, causing pain and functional impotence.
Appropriate deterioration mitigation strategies include, but are not limited to, strengthening programs of sufficient intensity to stimulate anabolism and limit muscle loss and increase strength. The general recommendation for increasing muscle strength and neural adaptations in healthy subjects after sustaining an elbow fracture is moderate to heavy load resistance training with loads approximating 60%-80% of the one repetition maximum ( 1RM). However, high joint stress would be challenging and increase the risk of adverse consequences in such patients, so strategies are still needed to meet the challenges of effectively and safely adapting training loads to safely enable improvement. without requiring high joint stress.
Resistance band work, coupled with the use of dual tasks, is a novel approach used during resistance training, especially among healthy populations, with promising results.
The purpose of the study is to evaluate neuromuscular responses, pain intensity and RPE in patients with elbow joint fracture, with or without surgical approach, with different strategies to strengthen the upper limb.
Candidates for this study will be men and women over 18 years of age who have been diagnosed with a fracture of the elbow joint (types 1-3 and types 2-1 according to Müller's OA fracture classification), with or without a surgical approach and with date of injury and completion of their physiotherapy program in 2022-2023, and who begin their physiotherapy treatment between weeks 7 to 9 post-fracture.
The patients will voluntarily participate in the study, which will be carried out at the Hospital Clínico Universitario de Valencia, during the months of May 2022 to May 2023. All participants will be informed about the objectives and content of the research and information will be obtained. written informed consent. The study will conform to the Declaration of Helsinki and will be approved by the local ethics committee.
Participants will be excluded if they have any involvement in the contralateral upper limb, if they have already had/have any other injury to the elbow or other anatomical part of the affected MS (in the last year), and if they have any other condition or disease in the which there is a contraindication to physical exercise. Also if they participate in physiotherapy programs external to the one carried out by us or in other research studies. In addition, if there is evidence of a severe failure in bone consolidation (separation greater than 5 mm), if there is neural injury, CRPS (Complex Regional Pain Syndrome), severe open fracture with muscle and periosteal loss, clinical picture not competent for physiotherapy by diagnosis doubtful and severe congenital instability of MMSS.
First, an observational session will be held. Patients will then be randomized into 2 groups: one group with strength training and one with strength training and dual task.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dual task strength training | Experimental | Other: dual task strength trainingThe participants of this group will perform their training following the dual task described. |
| strength training | Active comparator | Other: dual task strength trainingThe participants of this group will perform the work of strengthening the upper limb in a conventional way. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Candidates for this study will be men and women over 18 years of age who have been diagnosed with a fracture of the elbow joint (types 1-3 and types 2-1 according to Müller's OA fracture classification), with or without a surgical approach and with date of injury and completion of their physiotherapy program in 2022-2023, and who begin their physiotherapy treatment between weeks 7 to 9 post-fracture.
- The patients will voluntarily participate in the study, which will be carried out at the Hospital Clínico Universitario de Valencia, during the months of May 2022 to May 2023. All participants will be informed about the objectives and content of the research and information will be obtained. written informed consent. The study will conform to the Declaration of Helsinki and will be approved by the local ethics committee.
Key exclusion criteria (1 listed)
- Participants will be excluded if they have any involvement in the contralateral upper limb, if they have already had/have any other injury to the elbow or other anatomical part of the affected MS (in the last year), and if they have any other condition or disease in the which there is a contraindication to physical exercise. Also if they participate in physiotherapy programs external to the one carried out by us or in other research studies. In addition, if there is evidence of a severe failure in bone consolidation (separation greater than 5 mm), if there is neural injury, CRPS (Complex Regional Pain Syndrome), severe open fracture with muscle and periosteal loss, clinical picture not competent for physiotherapy by diagnosis doubtful and severe congenital instability of MMSS.
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 |
|---|---|---|
| dual task strength trainingstrength training and dual task | Other | dual task strength training, strength training |
Primary outcome
Isometric elbow extension/flexion force
Time frame: 12 weeks
They will be evaluated with a portable handheld dynamometer. The tests will be carried out against a fixed resistance: the participants were with their elbows at 90º, in a sitting position with an upright posture, without a backrest and with both feet placed flat on the floor, with force exerted against a fixed table. 3 maximum contractions of 5 seconds will be performed, separated by 1 minute of rest, selecting the average value of these 3 for later analysis.
Self-reported pain intensity
Time frame: 12 weeks
The patient marks a point on the scale and subsequently, the clinician or researcher quantifies the number of mm indicated by the patient.Therefore, the self-perceived pain intensity range travels from 0-100 mm. VAS is the most widely used so far in research to assess pain intensity. higher scores mean a worse outcome
3 secondary outcomes
Kinesiophobia
Time frame: 12 weeks
Shoulder Disability
Time frame: 12 weeks
passive range of motion
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Elbow Fracture
Not yet recruiting
Comparison of GMI, PNF, and Standard Care for Post-Traumatic Elbow Stiffness Rehabilitation in Adults
Elbow Stiffess, Rehabilitation Treatment
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Treatment of Olecranon Fractures in the Elderly
Olecranon Fracture
Recruiting
This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment
Olecranon Fracture
Recruiting
The With Or Without Olecranon K-wires Trial
Olecranon Fracture
Not yet recruitingObservational study
Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System
Intra-Articular or Extra-Articular Distal Humerus Fracture, Distal Humerus Fracture
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.
Laura López-Bueno principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual task strength training in people with Elbow Fracture, run by University of Valencia at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 29 Feb 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric elbow extension/flexion force (time frame: 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 29 Feb 2024.