NCT02974062

Brief Summary

The purposes of this study were to 1) determine test-retest reliability of an iPhone application measurement and protocol, 2) establish minimal detectable change of an iPhone application measurement and protocol, and 3) determine the immediate effect of core stabilization exercise on trunk proprioception in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

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

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

1 month

First QC Date

November 21, 2016

Last Update Submit

March 28, 2017

Conditions

Keywords

Position senseLumbar stabilization exercise

Outcome Measures

Primary Outcomes (1)

  • Lumbar position sense

    Absolute repositioning error measured by an iPhone application was used to determine change in lumbar position sense after 1 session (30 minutes) of lumbar stabilization exercise

    Change from baseline lumbar position sense after receiving a 30-minute lumbar stabilization exercise

Study Arms (2)

Lumbar stabilization exercise

EXPERIMENTAL

Lumbar stabilization exercised is a low-intensity exercise that focuses on motor control of deep abdominal and back muscles, rather than their strength or endurance. There are 3 main levels in this exercise; 1) co-contraction of deep abdominal and back muscles, 2) co-contraction with limb movement (self-perturbation), and 3) co-contraction with functional movement (i.e. walking, running, etc.)

Other: Lumbar stabilization exercise

Healthy control

NO INTERVENTION

No intervention was given to this group of participants. They were asked to rest and wait for 15 minutes, then post-test was performed.

Interventions

Participants were trained using lumbar stabilization exercise based on their initial lumbar stability level. They were received a 30-minute exercise for 1 session in this study.

Lumbar stabilization exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 40
  • No episode of back pain for 3 months prior to the participation
  • No regular exercise routine that is composed of core stabilization exercise We select the age range between 18 and 40 years because one of the previous study demonstrated that patients with non-specific low back pain who had age below 40 years old were more likely to have clinical lumbar instability and would benefit from core stabilization exercise.15 In addition, patients older than 40 years old are more likely to have a specific low back condition,46 such as degenerative spine, spondylosis, or spinal stenosis, which may interfere with our interpretation of the effect of core stabilization exercise on trunk proprioception.

You may not qualify if:

  • Clinical signs of systemic disease
  • Definitive neurologic signs including weakness or numbness in the lower extremity
  • Previous spinal surgery
  • Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
  • Pregnancy
  • Any lower extremity condition that would potentially alter trunk movement
  • Vestibular dysfunction
  • Extreme psychosocial involvement
  • Body mass index (BMI) greater than 30 kg/m2
  • Active treatment of another medical illness that would preclude participation in any aspect of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (2)

  • Hebert JJ, Koppenhaver SL, Magel JS, Fritz JM. The relationship of transversus abdominis and lumbar multifidus activation and prognostic factors for clinical success with a stabilization exercise program: a cross-sectional study. Arch Phys Med Rehabil. 2010 Jan;91(1):78-85. doi: 10.1016/j.apmr.2009.08.146.

    PMID: 20103400BACKGROUND
  • O'Sullivan PB. Lumbar segmental 'instability': clinical presentation and specific stabilizing exercise management. Man Ther. 2000 Feb;5(1):2-12. doi: 10.1054/math.1999.0213.

    PMID: 10688954BACKGROUND

Study Officials

  • Peemongkon Wattananon, PhD

    Faculty of Physical Therapy, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 28, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

All data will be made available for other researchers after the end of the study.

Locations