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

Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit in Cervical Range of Motion, Muscle Endurance and Neck Disability.

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Cervical Disability
• Intervention / Treatment: Other: Training protocol with the device cervical for treatment (CDAT); Other: Conventional training protocol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50018
    • Élite Fisioterapia, María Montessori 2.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Subject continues with activities of daily living. Does not receive deep cervical muscle training.
Experimental: 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.	Other: Training protocol with the device cervical for treatment (CDAT); Training protocol with the cervical device for treatment (CDAT)
Active Comparator: 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.	Other: Conventional training protocol; Conventional training protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index	Mean change from baseline in Neck Disability Index (NDI) (Neck Function) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the self-perceived disability from neck pain using the NDI. The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. The measure is designed to be given to the patient to complete. Item scores range from 0 (no disability) to 5 (total disability), with the minimum score is 0 (no disability) and maximum score of 50 (complete disability).	Baseline and 6 weeks, 10 weeks, 14 weeks
Craniocervical flexion test	The examiners assess the strength of deep cervical flexors with craniocervical flexion test.	Baseline and 6 weeks, 10 weeks, 14 weeks
Cervical Spine range of motion	Mean change from baseline in Lower and Upper Cervical Spine Range of Movement (ROM) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left sidebending, right/left rotation will be evaluated. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension and flexion rotation test will be evaluated. Flexion rotation test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32.	Baseline and 6 weeks, 10 weeks, 14 weeks
GLOBAL RATING OF CHANGE SCALE (GROC)	The examiners assess self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores after 6 weeks, 10 weeks and 14 weeks. The GROC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter. Item scores range from - 7 (A very great deal worse) to + 7 A very great deal better.	Baseline and 6 weeks, 10 weeks, 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity enjoyment Scale (PACES)	The examiners assess participant satisfaction with cervical deep muscle training. This scale measures enjoyment during physical activity through 16 items, which are preceded by the phrase "When I am active…" This instrument measures enjoyment and bipolar enjoyment, through statements such as "I enjoy it", "I'm bored", "It's very exciting", and "I don't like it". The answers will be collected on a Likert scale from 1 (totally disagree) to 5 (totally agree).	6 weeks
The Borg Rating of Perceived Exertion (RPE) Scale.	The examiners assess perceived exertion by the participant during exercise. The Rating of Perceived Exertion (RPE) scale is based on a range between 0 and 10, with 0 being the least amount of exertion and 10 being the maximum level of exertion. The examiners assess perceived exertion by the participant during exercise.	6 weeks

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Investigators: Principal Investigator: Pilar Pardos-Aguilella, teacher, UicCatalunya

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Actual): September 11, 2022
• Study Completion (Actual): October 11, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: muscle weakness; neck pain; exercise therapy; telerehabilitation; neck muscles
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Muscle Weakness; Paresis
• Other Study ID Numbers: C.P. - C.I. PI21/357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No