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

NCT05380219 | Completed

• 1 other identifier: ID0001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Elbow Fracture

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  12 weeks

Secondary Outcomes (3)

• Kinesiophobia

  12 weeks

• Shoulder Disability

  12 weeks

• passive range of motion

  12 weeks

Study Arms (2)

dual task strength training

EXPERIMENTAL

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

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.

Other: dual task strength training

Interventions

dual task strength training OTHER

strength training and dual task

dual task strength training; strength training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Laura López-Bueno

Valencia, 46005, Spain

Location

MeSH Terms

Conditions

Elbow Fractures

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Laura López-Bueno

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: June 5, 2022
• Primary Completion: October 9, 2023
• Study Completion: October 9, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)