Cervical Functionality and Posture (CERFUPOS)
Condition: People With Impaired Motor Function in the Cervical Region
Study type: Interventional

Summary: 
      BACKGROUND: Musculoskeletal alterations of the cervical region constitute clinical situations
      with a high prevalence that may be related to posture mismatches. Static alterations not
      linked to a defined pathological picture may come from a sensory-motor disorder whose main
      manifestations are increased muscle tone and stiffness. Postural reconstruction (RP). The RP
      method has as main objective the rebalancing of the muscular tone from 1) the sensorimotor
      recovery and 2) the re-functionalization of the subcortical toninergic centers. The aim of
      this study is to determine the effect of this physiotherapeutic approach on the functionality
      and posture of the cervical region.

      OBJECTIVES: 1) to know the effect of PR on cervical function in subjects with impaired
      cervical motor function; and 2) to know the effect of PR on static in subjects with impaired
      cervical motor function.

      PARTICIPANTS & METHODS: quasi-experimental design, with only one intervention group (N=40).
      Data records before and after the 1st intervention, before the 2nd, 4th and 6th weekly
      treatment sessions, at 15 days and a month and at 3 months after the end of treatment.

      INTERVENTION: The intervention will consist of the application of a RP maneuver applied to
      both lower limbs to obtain improvements in the cranio-cervical region.

      OUTCOMES: The outcome variables will collect information on active joint movement in the
      cervical region, anatomical references representative of body statics, cervical
      repositioning, cervical disability, pain and time to extinction of the effect.
    

Detailed description: 
      SAMPLE: People between 18-45 years old and with 1) alteration of active cervical mobility in
      at least one of the six directions of analytic movement compared to normality or with
      alteration of motor control of the cervical region in at least one of the 7 tests included in
      the study compared to normal criteria.

      SAMPLE SIZE: The minimum size required has been calculated using the program G*Power 3.1.3
      for Windows (University Kiel, Germany, 2008) based on an effect size of 0.5, type I error of
      5%,type II error of 10%, an effect size of delta=0.20, a intra-measures correlation =0.5 for
      7 measurement points. An extra 20% for drop-outs was added. The final sample size is N=40.

      INTERVENTION:

      Maximum external rotation of the hip in lower limb elevation and the dorsal flexion of the
      ankle with flexion of the toes, performed in both lower limbs alternately and independently.
      During the performance of the technique, the patient must implement the work breathing
      learned in the first basal assessment session.

      It will be applied weekly during 6 consecutive weeks.

      DATA ANALYSIS:

        1. -Database cleaning and out-of-range data detection using Excel validation techniques.

        2. -For statistical analysis, a descriptive analysis using means and standard deviations
           will be performed, as well as ranges and quartiles for quantitative measurements.
           Qualitative variables shall be summarised by counts and frequencies. The assumption of
           normality (Kolmogorv-Smirnoff test) and sphericity (Maulchy's test) prior to the
           analysis of variance (ANOVA) will be checked for repeated measurements in which only the
           intra-unit factors (7 time measurements). Pair comparisons were made with the
           Dunn-Bonferroni correction for type I erro and the age, sex and BMI variables were
           entered into the model as covariates to estimate their possible effect on the dependent
           variables.

      The percentages of change from the baseline values in the intragroup comparison shall be
      calculated. The effect size will be estimated with the Hedges' g statistic.

      The significance level will be set to p<0.05 and calculations will be performed with jmv r
      package for R (R Core Team, 2019. R: A language and environment for statistical. computing. R
      Foundation for Statistical Computing, Vienna, Austria. URL http://www.R-project.org/)
    

Intervention name(s): Postural reconstruction
Intervention type(s): Procedure
Intervention description(s): Interventions are described in group descriptions
Intervention model: Single Group Assignment
Intervention model description: One group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical pain; Funcionality; Posture; Balance; Muscular tone; Postural reconstruction; Physical Therapy