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

NCT ID: NCT04201483

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-05

Study Completion Date

2020-04-20

Brief Summary

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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

Detailed Description

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Participants will be randomly allocated into two exercise groups: "DCE exercise without RUSI feedback (DCE)" and "DCE exercise with RUSI feedback (DCE+RUSI)".

Participants assigned to DCE will perform an exercise known to selectively activate the semispinalis cervicis muscles. By the other hand, participants in the DCE+RUSI group will perform the same exercise as the DCE group to selectively activate the semispinalis cervicis muscle but receiving RUSI feedback about correct performance. In both groups, a total of 10 sets of 10 repetitions will be performed with one minute of rest between each set.

Ultrasound measurement will be used to asses the antero-posterior dimension (thickness) of the DCE both at rest and during contraction at the level of C4 at baseline, immediately after the DCE exercise activation protocol and one-week follow-up in order to evaluate retention capacity.

All participants will be asked to not perform any other cervical motor control exercise or exercise using RUSI feedback until the last time point assessment will be finished.

All participants will be asked to avoid any exercises or treatments for neck pain between sessions.

All ultrasound images will be analysed off-line using Image J software. Thickness and percent thickness change will be measured. The percent thickness change will be calculated by using the following equation: thickness contracted - thickness rest / thickness rest.

Conditions

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Neck Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 (EpidatĀ® version 3.1). Allocation concealment will be ensured using opaque and sealed envelopes
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Ultrasound measurements will be performed by the rater responsible of performing ultrasound measurements who will be blinded to the assigned group

Study Groups

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DCE group

DCE exercise without RUSI feedback

Group Type ACTIVE_COMPARATOR

DCE without RUSI feedback

Intervention Type OTHER

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

DCE + RUSI group

DCE exercise with RUSI feedback

Group Type EXPERIMENTAL

DCE + RUSI feedback about performance

Intervention Type 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

Interventions

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DCE without RUSI feedback

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

Intervention Type OTHER

DCE + RUSI feedback about performance

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Physiotherapy. University of Valencia

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Fernando Dominguez, Pt

Role: primary

Other Identifiers

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1574447392087

Identifier Type: -

Identifier Source: org_study_id