NCT03567122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

Same day

First QC Date

June 1, 2018

Last Update Submit

July 7, 2019

Conditions

Neck; AnomalyMuscle WeaknessMuscle Weakness Condition

Keywords

Cranio-cervicalMotor ControlDeep Flexor muscles

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)

  • Cranio-Cervical Flexion Test Performance

    Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)

Study Arms (3)

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.

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.

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.

Other: Control

Interventions

Internal Focus of AttentionOTHER

Information already included in arm/group descriptions.

Also known as: Internal Focus
Internal Focus of Attention
External Focus of AttentionOTHER

Information already included in arm/group descriptions.

Also known as: External Focus
External Focus of Attention
ControlOTHER

Information already included in arm/group descriptions.

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Asymptomatic subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Ciências da Saúde

Porto Alegre, Rio Grande do Sul, 90160240, Brazil

Location

MeSH Terms

Conditions

Congenital AbnormalitiesMuscle Weakness

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Marcelo Faria, PhD, PT

    Professor, Researcher

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Ivestigator

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 25, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2018

Study Completion

April 1, 2019

Last Updated

July 9, 2019

Record last verified: 2019-07

Locations

BR(1)