Stabilizer in Abdominal Wall Muscles

Sponsor
Universidad Europea de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT03434756
Collaborator
(none)
41
1
1
7
178.3

Study Details

Study Description

Brief Summary

The aim of the study will be tried to observe if the propioceptive Stabilizer training is effective in abdominal wall muscles in healthy subjects. All the participants will be examined in two times. Initially, baseline measurements with ultrasound imaging will be taken without muscle activity. After, they will do the abdominal manoeuvre and it will take the ultrasound images.

Condition or Disease Intervention/Treatment Phase
  • Other: Propioceptive training of the abdominal wall muscles
N/A

Detailed Description

Inclusion criteria will be health participants with age between 18 to 45 years. Exclusion criteria were a BMI higher than 31 kg/m2, hypocapnia, any musculoskeletal condition in lumbopelvic region, skin and lower limb pathology (i.e., fracture, surgery).

Initially, baseline measurements will make following Whittaker et al. guidelines to measure thickness of the abdominal wall muscles (external oblique, EO; internal oblique, IO; transversus abdominis, TrA and rectus anterior, RA). All evaluations will be carry out by a single operator (B.M.P), who was a specialized physical therapist with 3 years of USI experience. A diagnostic ultrasound tool (Toshiba Aplio 500 Platinum, Toshiba American Medical Systems; CA, USA) with a 7 to 14-MHz-range linear transducer (18L7 PLT-1204BT type; 40-mm footprint) will be used for B mode ultrasound imaging. Ultrasound images of the EO, IO and TrAb muscles will be taken with the patients in supine position, with a cross reference point placed between the iliac crest and the inferior border of subcostal line, and the midaxilary line on the right side ; RA muscle was aligned with the umbilicus; and interrecti distance (IRD) will be measured just under the umbilicus. The measure for the thickness during the rest condition will be perform by the mean of 3 repeated values for each measure at the end of expiration, maintaining the transducer at the same point. Muscle thickness will be considered as the distance between the inside caliper lines of each muscle border. IRD will be described as the distance between the inside caliper lines of each RA muscles.

Once baseline measurements will be taken, the same measurements will make while the patients perform the exercise. This exercise specifically targets the abdominal wall muscles (EO, IO, TrA and RA). At the beginning, patients will be in a supine position, the lower edge of the StabilizerTM will be placed between the posterior superior iliac spines, aligned with the sacral base. Abdominal draw in maneuver (ADIM) was developed by the patients until they reach 40 mmHg and hold steadily for 10 seconds. Prior the examination, each subject will be practiced the ADIM three times with an ultrasound image feedback.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Propioceptive StabilizerTM Training in the Abdominal Wall Muscles in Healthy Subjects: A Pilot Study
Actual Study Start Date :
Feb 18, 2018
Actual Primary Completion Date :
Feb 22, 2018
Actual Study Completion Date :
Feb 25, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Propioceptive Training

Other: Propioceptive training of the abdominal wall muscles
At the beginning, patients will be in a supine position, the lower edge of the StabilizerTM will be placed between the posterior superior iliac spines, aligned with the sacral base. Abdominal manoeuvre will be developed by the patients until they reach 40 mmHg and hold steadily for 10 seconds. Prior the examination, each subject practiced the abdominal manoeuvre three times with an ultrasound image feedback.

Outcome Measures

Primary Outcome Measures

  1. Thickness abdominal wall muscles [1 day]

    The measure for the thickness during the rest condition will be perform by the mean of 3 repeated values for each measure at the end of expiration, maintaining the transducer at the same point. IRD will be only evaluated in the midline. Muscle thickness will be considered as the distance between the inside caliper lines of each muscle border. Interrecti distance will be described as the distance between the inside caliper lines of each Rectus Anterioris muscles.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy adults
Exclusion Criteria:
  • Body mass index higher than 31 kg/m2,

  • Hypocapnia,

  • Any musculoskeletal condition in lumbopelvic region,

  • Skin and lower limb pathology (i.e., fracture, surgery)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Europea de Madrid Madrid Spain

Sponsors and Collaborators

  • Universidad Europea de Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Carlos Romero Morales, PhD, Universidad Europea de Madrid
ClinicalTrials.gov Identifier:
NCT03434756
Other Study ID Numbers:
  • CIPI/087/17
First Posted:
Feb 15, 2018
Last Update Posted:
Apr 18, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carlos Romero Morales, PhD, Universidad Europea de Madrid

Study Results

No Results Posted as of Apr 18, 2018