NCT03434756

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 18, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

4 days

First QC Date

February 6, 2018

Last Update Submit

April 16, 2018

Conditions

Keywords

ultrasound imagingpropioceptiontraining

Outcome Measures

Primary Outcomes (1)

  • Thickness abdominal wall muscles

    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.

    1 day

Study Arms (1)

Propioceptive Training

EXPERIMENTAL
Other: Propioceptive training of the abdominal wall muscles

Interventions

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.

Propioceptive Training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults

You may not qualify if:

  • Body mass index higher than 31 kg/m2,
  • Hypocapnia,
  • Any musculoskeletal condition in lumbopelvic region,
  • Skin and lower limb pathology (i.e., fracture, surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Spain

Location

Related Publications (2)

  • Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558.

    PMID: 17877281BACKGROUND
  • Miura T, Yamanaka M, Ukishiro K, Tohyama H, Saito H, Samukawa M, Kobayashi T, Ino T, Takeda N. Individuals with chronic low back pain do not modulate the level of transversus abdominis muscle contraction across different postures. Man Ther. 2014 Dec;19(6):534-40. doi: 10.1016/j.math.2014.05.010. Epub 2014 Jun 20.

    PMID: 25009124BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 15, 2018

Study Start

February 18, 2018

Primary Completion

February 22, 2018

Study Completion

February 25, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations