Back to resultsAttentional Focus Influence During Cranio-Cervical Flexion Test
Primary Purpose
Neck; Anomaly, Muscle Weakness, Muscle Weakness Condition
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Internal Focus of Attention
External Focus of Attention
Control
Sponsored by
About this trial
This is an interventional treatment trial for Neck; Anomaly focused on measuring Cranio-cervical, Motor Control, Deep Flexor muscles
Eligibility 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
Sites / Locations
- Universidade Federal de Ciências da Saúde
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Internal Focus of Attention
External Focus of Attention
Control
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03567122
First Posted
June 1, 2018
Last Updated
July 7, 2019
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03567122
Brief Title
Attentional Focus Influence During Cranio-Cervical Flexion Test
Official Title
Attentional Focus Influence During Cranio-Cervical Flexion Test
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck; Anomaly, Muscle Weakness, Muscle Weakness Condition
Keywords
Cranio-cervical, Motor Control, Deep Flexor muscles
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internal Focus of Attention
Arm Type
Experimental
Arm Description
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.
Arm Title
External Focus of Attention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Internal Focus of Attention
Other Intervention Name(s)
Internal Focus
Intervention Description
Information already included in arm/group descriptions.
Intervention Type
Other
Intervention Name(s)
External Focus of Attention
Other Intervention Name(s)
External Focus
Intervention Description
Information already included in arm/group descriptions.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Information already included in arm/group descriptions.
Primary Outcome Measure Information:
Title
Change from baseline in Electromyographic Activity of Sternocleidomastoid
Description
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.
Time Frame
Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
Secondary Outcome Measure Information:
Title
Cranio-cervical Range of Motion
Description
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.
Time Frame
Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
Title
Cranio-Cervical Flexion Test Performance
Description
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.
Time Frame
Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Faria, PhD, PT
Organizational Affiliation
Professor, Researcher
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de Ciências da Saúde
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90160240
Country
Brazil
12. IPD Sharing Statement
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Attentional Focus Influence During Cranio-Cervical Flexion Test
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