Muscle WeaknessNCT05288712
Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit.
A study testing Training protocol with the device cervical for treatment (CDAT) and Conventional training protocol in people with Muscle Weakness and Cervical Disability, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Weakness, Cervical Disability
- What is being tested?
- Training protocol with the device cervical for treatment (CDAT) and Conventional training protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 11 Mar 2022to 11 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deep flexor strength deficit in craniocervical flexion test.
- Deep extensor strength deficit in neck extensor muscle endurance test.
- ≤ 14 score in Neck disability Index.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Weakness, Cervical Disability
- Being tested
- Training protocol with the device cervical for treatment (CDAT), Conventional training protocol
- Keywords
- neck pain, exercise therapy, muscle weakness, telerehabilitation, neck muscles
- Medical subject headings
- Muscle Weakness, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training protocol with the device cervical for treatment (CDAT)Other
Training protocol with the cervical device for treatment (CDAT)
Conventional training protocolOther
Conventional training protocol
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Training protocol with the cervical device for treatment (CDAT). | Experimental | 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. Receives: Other: Training protocol with the device cervical for treatment (CDAT) |
| Conventional training protocol: | Active comparator | Endurance and stabilization training program of deep cervical flexors with conventional protocol.
Endurance and stabilization training program of deep cervical extensors with conventional protocol. Receives: Other: Conventional training protocol |
| Control Group | No intervention | Subject continues with activities of daily living. Does not receive deep cervical muscle training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline and 6 weeks, 10 weeks, 14 weeks
Craniocervical flexion test
The examiners assess the strength of deep cervical flexors with craniocervical flexion test.
Measured: 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.
Measured: Baseline and 6 weeks, 10 weeks, 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start11 Mar 2022
- Primary completion11 Sep 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized controlled trial with 3 different groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pilar Pardos Aguilella, Universitat Internacional de Catalunya
- Investigators
- Pilar Pardos-Aguilella, teacher, Principal investigator, UicCatalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288712
- Sponsor's protocol ID
- C.P. - C.I. PI21/357
- Status last verified
- Aug 2023
- First submitted
- 10 Mar 2022
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05288712
- Acronym / sponsor ID
- C.P. - C.I. PI21/357
- Conditions
- Muscle Weakness, Cervical Disability
- Keywords
- neck pain, exercise therapy, muscle weakness, telerehabilitation, neck muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This will be a randomized controlled trial with 3 different groups
| Arm | Type | Receives |
|---|---|---|
| Experimental: Training protocol with the cervical device for treatment (CDAT). | Experimental | Other: Training protocol with the device cervical 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. |
| Conventional training protocol: | Active comparator | Other: Conventional training protocolEndurance and stabilization training program of deep cervical flexors with conventional protocol. Endurance and stabilization training program of deep cervical extensors with conventional protocol. |
| Control Group | No intervention | –Subject continues with activities of daily living. Does not receive deep cervical muscle training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Deep flexor strength deficit in craniocervical flexion test.
- Deep extensor strength deficit in neck extensor muscle endurance test.
- ≤ 14 score in Neck disability Index.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training protocol with the device cervical for treatment (CDAT)Training protocol with the cervical device for treatment (CDAT) | Other | Experimental: Training protocol with the cervical device for treatment (CDAT). |
| Conventional training protocolConventional training protocol | Other | Conventional training protocol: |
Primary outcome
Neck Disability Index
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
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).
Cervical Spine range of motion
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
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.
Craniocervical flexion test
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
The examiners assess the strength of deep cervical flexors with craniocervical flexion test.
GLOBAL RATING OF CHANGE SCALE (GROC)
Time frame: Baseline and 6 weeks, 10 weeks, 14 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Pardos-Aguilella, teacher principal investigator
UicCatalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training protocol with the device cervical for treatment (CDAT) and Conventional training protocol in people with Muscle Weakness and Cervical Disability, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: Baseline and 6 weeks, 10 weeks, 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.