Attentional Focus Influence During Cranio-Cervical Flexion Test

• ClinicalTrials.gov Identifier: NCT03567122
• Recruitment Status: Completed
• First Posted: June 25, 2018
• Last Update Posted: July 9, 2019
• Sponsor: Federal University of Health Science of Porto Alegre
• Information provided by (Responsible Party): Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Neck; Anomaly; Muscle Weakness; Muscle Weakness Condition	Other: Internal Focus of Attention; Other: External Focus of Attention; Other: Control	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Attentional Focus Influence During Cranio-Cervical Flexion Test
• Actual Study Start Date: August 1, 2018
• Actual Primary Completion Date: August 1, 2018
• Actual Study Completion Date: April 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Internal Focus of Attention; 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.	Other: Internal Focus of Attention; Information already included in arm/group descriptions.; Other Name: Internal Focus
Experimental: External Focus of Attention; 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.	Other: External Focus of Attention; Information already included in arm/group descriptions.; Other Name: External Focus
Active Comparator: Control; 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.	Other: Control; Information already included in arm/group descriptions.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Cranio-cervical Range of Motion [ Time Frame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training) ]
   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.
2. Cranio-Cervical Flexion Test Performance [ Time Frame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Asymptomatic subjects

Exclusion Criteria:

• Cervical pain
• Historic of trauma/surgery to the cervical or thoracic spine or upper limbs
• Temporomandibular pain
• Neurological or systemic disorder

Contacts and Locations

Locations

Brazil

Universidade Federal de Ciências da Saúde

Porto Alegre, RS, Brazil, 90160240

Sponsors and Collaborators

Federal University of Health Science of Porto Alegre

Investigators

• Study Director: Marcelo Faria, PhD, PT; Professor, Researcher

More Information

• Responsible Party: Francisco Xavier de Araujo, Pt, Principal Ivestigator, Federal University of Health Science of Porto Alegre
• ClinicalTrials.gov Identifier: NCT03567122
• Other Study ID Numbers: MSS_ME_01
• First Posted: June 25, 2018
• Last Update Posted: July 9, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre:

Cranio-cervical; Motor Control; Deep Flexor muscles

Additional relevant MeSH terms:

Muscle Weakness; Paresis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes