Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit.

NCT ID: NCT05288712

Last Updated: 2025-06-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2022-10-11

Brief Summary

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The purpose of this study is to evaluate the clinical results produced by a training protocol with the new device for cervical treatment (CDAT) and the conventional training protocol (CT) versus a control group (C) in subjects with cervical deep muscle strength deficit and mild neck disability.

Detailed Description

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Cervical pain is in many cases a decrease in the quality of life.The cervical spine is the most mobile region of the spine which also must be strong enough in order to support the weight of the skull. Deficits in deep cervical muscle strength are related to different clinical conditions: cervicogenic dizziness, cervical radiculopathy, cervical mechanical-chronic, cervical pain and cervical instability. Training protocols can help to improve pain, cervical function, posture and cross-sectional area. However, there are no training protocols in subjects with mild disability and strength deficit of the deep cervical muscle, including deep neck extensor and flexor muscles. The cervical device treatment (CDAT) allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.

Conditions

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Muscle Weakness Cervical Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a randomized controlled trial with 3 different groups
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes Assessor

Study Groups

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Experimental: Training protocol with the cervical device for treatment (CDAT).

Endurance and stabilization training program of deep cervical flexors with the cervical device for treatment.

Endurance and stabilization training program of deep cervical extensors with the cervical device for treatment.

Group Type EXPERIMENTAL

Training protocol with the device cervical for treatment (CDAT)

Intervention Type OTHER

Training protocol with the cervical device for treatment (CDAT)

Conventional training protocol:

Endurance and stabilization training program of deep cervical flexors with conventional protocol.

Endurance and stabilization training program of deep cervical extensors with conventional protocol.

Group Type ACTIVE_COMPARATOR

Conventional training protocol

Intervention Type OTHER

Conventional training protocol

Control Group

Subject continues with activities of daily living. Does not receive deep cervical muscle training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Training protocol with the device cervical for treatment (CDAT)

Training protocol with the cervical device for treatment (CDAT)

Intervention Type OTHER

Conventional training protocol

Conventional training protocol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Deep flexor strength deficit in craniocervical flexion test.
* Deep extensor strength deficit in neck extensor muscle endurance test.
* ≤ 14 score in Neck disability Index.

Exclusion Criteria

* Have received cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
* Have received cervical manual therapy treatment during the last six month.
* A history of cervical trauma or surgery during the last year.
* Chronic neck pain occurring during the last six months (intensity, visual analogue scale \>3/10, frequency \> 2 days/week, duration \>3 hours/day).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Pilar Pardos Aguilella

Collaborating Teacher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pilar Pardos-Aguilella, teacher

Role: PRINCIPAL_INVESTIGATOR

UicCatalunya

Locations

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Élite Fisioterapia, María Montessori 2.

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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C.P. - C.I. PI21/357

Identifier Type: -

Identifier Source: org_study_id

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