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Effects of Dual Task on Physical Function in Patients With Elbow Joint Fracture (DTelbow)

Primary Purpose

Elbow Fracture

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
dual task strength training
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Fracture

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Laura López-Bueno

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dual task strength training

strength training

Arm Description

The participants of this group will perform their training following the dual task described.

The participants of this group will perform the work of strengthening the upper limb in a conventional way.

Outcomes

Primary Outcome Measures

Mobility
The experimental protocol begins with the evaluation of neuromuscular responses, self-perceived pain intensity and RPE from the use of different intensities of elastic resistance, during elbow flexion and extension. This intensity is selected because it appears to correspond to the appropriate weight which is equivalent to 30% of 1RM and is considered a light intensity.

Secondary Outcome Measures

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.
Shoulder functionality
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).
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.
Measurement of 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).
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.

Full Information

First Posted
May 12, 2022
Last Updated
January 9, 2023
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05380219
Brief Title
Effects of Dual Task on Physical Function in Patients With Elbow Joint Fracture
Acronym
DTelbow
Official Title
Effects of Dual Task During Upper Limb Strengthening on Physical Function and Pain in Patients With Elbow Joint Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dual task strength training
Arm Type
Experimental
Arm Description
The participants of this group will perform their training following the dual task described.
Arm Title
strength training
Arm Type
Active Comparator
Arm Description
The participants of this group will perform the work of strengthening the upper limb in a conventional way.
Intervention Type
Other
Intervention Name(s)
dual task strength training
Intervention Description
strength training and dual task
Primary Outcome Measure Information:
Title
Mobility
Description
The experimental protocol begins with the evaluation of neuromuscular responses, self-perceived pain intensity and RPE from the use of different intensities of elastic resistance, during elbow flexion and extension. This intensity is selected because it appears to correspond to the appropriate weight which is equivalent to 30% of 1RM and is considered a light intensity.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Kinesiophobia
Description
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.
Time Frame
12 weeks
Title
Shoulder functionality
Description
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).
Time Frame
12 weeks
Title
Self-reported pain intensity
Description
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.
Time Frame
12 weeks
Title
Measurement of range of motion
Description
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).
Time Frame
12 weeks
Title
Isometric elbow extension/flexion force
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura López-Bueno
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laura López-Bueno
City
Valencia
ZIP/Postal Code
46005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Dual Task on Physical Function in Patients With Elbow Joint Fracture

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