- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03567122
Attentional Focus Influence During Cranio-Cervical Flexion Test
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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RS
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Porto Alegre, RS, Brazil, 90160240
- Universidade Federal de Ciências da Saúde
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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Information already included in arm/group descriptions.
Other Names:
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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.
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Information already included in arm/group descriptions.
Other Names:
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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.
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Information already included in arm/group descriptions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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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.
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Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
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Cranio-Cervical Flexion Test Performance
Time Frame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
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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.
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Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
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Collaborators and Investigators
Investigators
- Study Director: Marcelo Faria, PhD, PT, Professor, Researcher
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSS_ME_01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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