Real-time Ultrasound Imaging as Feedback for Deep Cervical Extensors Activation

NCT04201483 | Unknown Phase 2

• 1 other identifier: 1574447392087
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study will be to determine the value of adding real-time ultrasound imaging (RUSI) as an external feedback tool for teaching the contraction of the deep cervical extensors (DCE) in healthy subjects. The potential benefit of RUSI to facilitate activation of the DCE during a specific motor task as well as the retention capacity of this motor task after a short period of training will be investigated

Conditions

Neck Disorder

Outcome Measures

Primary Outcomes (3)

• Deep cervical extensors function at baseline

  Ultrasound measurements will be used to asses the antero-posterior dimension (thickness) of the deep cervical extensors both at rest and during contraction at the level of C4

  Baseline

• Change of the deep cervical extensors function from baseline to immediately after intervention

  Ultrasound measurements will be used to asses the antero-posterior dimension (thickness) of the deep cervical extensors both at rest and during contraction at the level of C4

  From baseline to immediately after intervention

• Change of the deep cervical extensors function from baseline to one week after intervention

  Ultrasound measurements will be used to asses the antero-posterior dimension (thickness) of the deep cervical extensors both at rest and during contraction at the level of C4

  From baseline to one week after intervention

Study Arms (2)

DCE group

ACTIVE COMPARATOR

DCE exercise without RUSI feedback

Other: DCE without RUSI feedback

DCE + RUSI group

EXPERIMENTAL

DCE exercise with RUSI feedback

Other: DCE + RUSI feedback about performance

Interventions

DCE without RUSI feedback OTHER

Participants assigned to this group will perform an exercise known to selectively activate the semispinalis cervicis muscle

DCE group

DCE + RUSI feedback about performance OTHER

Participants in this group will perform the same exercise as the DCE group to selectively activate the semispinalis cervicis muscle but receiving RUSI feedback about correct performance

DCE + RUSI group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No actual neck pain
• Being able to understand Spanish language

You may not qualify if:

• Neck pain in the last 3 months
• Previous surgery in the neck region
• Neurological diseases or any other condition that may alter voluntary muscle contraction
• Previous experience with cervical motor control training exercises
• Previous experience using RUSI as an external feedback tool in any other body area

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy. University of Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Interventions

delta 24-sterol reductase

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Ultrasound measurements will be performed by the rater responsible of performing ultrasound measurements who will be blinded to the assigned group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a randomized clinical trial, with parallel groups and a blinded assessor performed in accordance with CONSORT guidelines. Participants will be randomized into two exercise groups: "DCE exercise without RUSI feedback (DCE)" and "DCE exercise with RUSI feedback (DCE+RUSI)". Randomization will be conducted using computer-generated random numbers (Epidat® version 3.1). Allocation concealment will be ensured using opaque and sealed envelopes

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 17, 2019
• Study Start: December 5, 2019
• Primary Completion: February 20, 2020
• Study Completion: April 20, 2020
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (1)