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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04201483
Other study ID # 1574447392087
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 5, 2019
Est. completion date April 20, 2020

Study information

Verified date December 2019
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 20, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
DCE without RUSI feedback
Participants assigned to this group will perform an exercise known to selectively activate the semispinalis cervicis muscle
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

Locations

Country Name City State
Spain Faculty of Physiotherapy. University of Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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