Neck; AnomalyNCT03567122
Attentional Focus Influence During Cranio-Cervical Flexion Test
A study testing Internal Focus of Attention and External Focus of Attention in people with Neck; Anomaly and Muscle Weakness, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to termine if a different attentional focus would alter the motor control in cervical muscles during the cranio-cervical test. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck; Anomaly, Muscle Weakness, Muscle Weakness Condition
- What is being tested?
- Internal Focus of Attention and External Focus of Attention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 1 Apr 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic subjects
Who cannot join
- Cervical pain
- Historic of trauma/surgery to the cervical or thoracic spine or upper limbs
- Temporomandibular pain
- Neurological or systemic disorder
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Ciências da Saúde
Porto Alegre, Rio Grande do Sul, 90160240
About this study
The purpose of this study is to termine if a different attentional focus would alter the motor control in cervical muscles during the cranio-cervical test.
Read the detailed description
Asymptomatic subjects will be recruited to this study. Superficial electromyography of the Sternocleidomastoid, Range of Motion (ROM) and Cranio-Cervical Flexion Test (CCFT) will be measured before, immediately after change in focus of attention, 2 days after training under a particular focus of attention, and 7 days after training the task under the same focus of attention.
Subjects will be randomized into three groups: Internal focus of attention, external focus of attention and control group.
- Conditions
- Neck; Anomaly, Muscle Weakness, Muscle Weakness Condition
- Being tested
- Internal Focus of Attention, External Focus of Attention, Control
- Keywords
- Cranio-cervical, Motor Control, Deep Flexor muscles
- Medical subject headings
- Congenital Abnormalities, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Focus of AttentionOther
Also called Internal Focus
Information already included in arm/group descriptions.
External Focus of AttentionOther
Also called External Focus
Information already included in arm/group descriptions.
ControlOther
Information already included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Internal Focus of Attention | Experimental | 30 subjects will be randomized to this arm. Only internal focus of attention feedback instructions will be given during the execution and training performing the Cranio-Cervical Flexion Test. The subjects allocated to this arm will not be allowed to use the visual feedback traditionally provided during the Cranio-cervical Flexion Test. Receives: Other: Internal Focus of Attention |
| External Focus of Attention | Experimental | 30 subjects will be randomized to this arm. Only external focus of attention feedback instructions will be given during the execution and training performing the Cranio-Cervical Flexion Test. The subjects allocated to this arm will not be allowed to use the visual feedback traditionally provided during the Cranio-cervical Flexion Test. In addition, they will use just a laser point attached to the head to guide their cranio-cervical flexion. Receives: Other: External Focus of Attention |
| Control | Active comparator | 30 subjects will be randomized to this arm. The participants allocated to this arm will be instructed as traditionally during the Cranio-Cervical Flexion Test. They will be given visual feedback while have their attention guided to the inner neck movement. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Electromyographic Activity of Sternocleidomastoid
The Electromyography (EMG) signal amplitude will be determined by the root mean square (RMS) value computed over intervals of 1 s during each 10-s contraction. RMS will be expressed as a percentage of the maximum RMS value during the reference voluntary contraction.
Measured: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
Secondary outcomes (2)
Cranio-cervical Range of Motion
A neutral position and full range of active cranio-cervical flexion photograph will be taken using a digital camera. That camera will be positioned on a tripod horizontally parallel to the subject's head/neck region at a distance of 80 cm, anatomical markers positioned on the tragus of the ear, the mental protuberance of the mandible and the lateral aspect of the neck. Photos will be taken when the subject reached each level of the craniocervical flexion test. The Cranio-cervical Range of Motion will be expressed as relative percentage of degrees compared to the full range of motion.
Measured: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
Cranio-Cervical Flexion Test Performance
Subjects will instructed to reach each one of the five stages (22-30 mmHg) of the test and hold the pressure as steady as possible for 10s. The stage will be mark as successful if the participant reaches the stage level and hold steady the pressure during the 10-s contrition. However, the individuals that reaches the stage-aimed pressure but are unable to maintain the pressure stable during the 10s contraction or use compensating strategies will be marked as unsuccessful.
Measured: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck; AnomalyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre
- Investigators
- Marcelo Faria, PhD, PT, Study director, Professor, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567122
- Sponsor's protocol ID
- MSS_ME_01
- Status last verified
- Jul 2019
- First submitted
- 1 Jun 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional Focus Influence During Cranio-Cervical Flexion Test
- ClinicalTrials.gov ID
- NCT03567122
- Acronym / sponsor ID
- MSS_ME_01
- Conditions
- Neck; Anomaly, Muscle Weakness, Muscle Weakness Condition
- Keywords
- Cranio-cervical, Motor Control, Deep Flexor muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 25 Jun 2018 (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 termine if a different attentional focus would alter the motor control in cervical muscles during the cranio-cervical test.
Detailed description
Asymptomatic subjects will be recruited to this study. Superficial electromyography of the Sternocleidomastoid, Range of Motion (ROM) and Cranio-Cervical Flexion Test (CCFT) will be measured before, immediately after change in focus of attention, 2 days after training under a particular focus of attention, and 7 days after training the task under the same focus of attention.
Subjects will be randomized into three groups: Internal focus of attention, external focus of attention and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internal Focus of Attention | Experimental | Other: Internal Focus of Attention30 subjects will be randomized to this arm. Only internal focus of attention feedback instructions will be given during the execution and training performing the Cranio-Cervical Flexion Test. The subjects allocated to this arm will not be allowed to use the visual feedback traditionally provided during the Cranio-cervical Flexion Test. |
| External Focus of Attention | Experimental | Other: External Focus of Attention30 subjects will be randomized to this arm. Only external focus of attention feedback instructions will be given during the execution and training performing the Cranio-Cervical Flexion Test. The subjects allocated to this arm will not be allowed to use the visual feedback traditionally provided during the Cranio-cervical Flexion Test. In addition, they will use just a laser point attached to the head to guide their cranio-cervical flexion. |
| Control | Active comparator | Other: Control30 subjects will be randomized to this arm. The participants allocated to this arm will be instructed as traditionally during the Cranio-Cervical Flexion Test. They will be given visual feedback while have their attention guided to the inner neck movement. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Asymptomatic subjects
Key exclusion criteria (4 listed)
- Cervical pain
- Historic of trauma/surgery to the cervical or thoracic spine or upper limbs
- Temporomandibular pain
- Neurological or systemic disorder
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 |
|---|---|---|
| Internal Focus of AttentionAlso: Internal FocusInformation already included in arm/group descriptions. | Other | Internal Focus of Attention |
| External Focus of AttentionAlso: External FocusInformation already included in arm/group descriptions. | Other | External Focus of Attention |
| ControlInformation already included in arm/group descriptions. | Other | Control |
Primary outcome
Change from baseline in Electromyographic Activity of Sternocleidomastoid
Time frame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
The Electromyography (EMG) signal amplitude will be determined by the root mean square (RMS) value computed over intervals of 1 s during each 10-s contraction. RMS will be expressed as a percentage of the maximum RMS value during the reference voluntary contraction.
2 secondary outcomes
Cranio-cervical Range of Motion
Time frame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
Cranio-Cervical Flexion Test Performance
Time frame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
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 9 Jul 2019.
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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.
Marcelo Faria, PhD, PT study director
Professor, Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Focus of Attention and External Focus of Attention in people with Neck; Anomaly and Muscle Weakness, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 1 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 9 Jul 2019. 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 Brazil. 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?
Change from baseline in Electromyographic Activity of Sternocleidomastoid (time frame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)). 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 9 Jul 2019.