Condition category
Musculoskeletal Diseases
Date applied
28/10/2018
Date assigned
30/10/2018
Last edited
30/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

In clinical and sports-related contexts, the assess of reliability and measurements errors from biomechanical instruments and observers in physical performance tests, are essential for establishment of protocols in training and rehabilitation programs relative to symmetry. Thus, the aims of this present study was to assess the intra-rater and test-retest reliability of physical performance tests symmetry between lumbar spinal manipulation in athletes.
Assessing the intra-rater and test-retest reliability of physical performance tests by ICC, SEM and MDC, our results demonstrated good reliability scores in terms of relative and absolute statistical reliability.

Background and study aims
Measuring symmetry of movement (how equal the movement is comparing the right and left sides of the body) is useful in healthcare and sports. This study aimed to investigate how similar the symmetry results are for the same person doing the same movement and how similar the symmetry results are for the same person comparing before and after they have had spinal manipulation therapy (SMT). These results will mean that the reliability of the symmetry measuring system can be assessed.

Who can participate?
Athletes aged 18-35 years who have no back problems or other health problems.

What does the study involve?
The participants will stand with their feet on two platforms. Cameras will capture their movements as they stand still, do a free squat and do a countermovement jump (a jump where you bend your knees before springing up). Then a doctor will give SMT to the lower back and the participants will then do the movement test again as before.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in their condition and reliable outcomes analyzed. Participants may experience discomfort during the lumbar SMT intervention.

Where is the study run from?
Biomechanics laboratory, Faculty of Human Kinetics, FMH. University of Lisbon, Portugal

When is the study starting and how long is it expected to run for?
August 2017 to November 2017

Who is funding the study?
The Brazilian Federal Agency for the Support and Evaluation of Graduate Education's Coordination for the Improvement of Higher Education Personnel scheme (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, CAPES)

Who is the main contact?
Bruno Araújo Procópio de Alvarenga, brunofisioquiro@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bruno Alvarenga

ORCID ID

Contact details

Tv. Henrique Cardoso
48
2 dto
Alvalade
Lisboa
1700228
Portugal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Assessing intra-rater and test-retest reliability of physical performance tests symmetry between lumbar spinal manipulation in asymptomatic athletes

Acronym

Study hypothesis

The aim of this study was to assess intra-rater and test-retest reliability of symmetry tests between lumbar spinal manipulation in asymptomatic athletes

Ethics approval

Ethics Committee of Faculty of Human Kinetics, University of Lisbon, 30/09/2017, FMH 31/2017

Study design

An prospective intra-rater and test-retest reliability study was performed.

Primary study design

Observational

Secondary study design

prospective study

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Asymptomatic athletes

Intervention

Participants performed tests while standing on two force platforms (left and right) with a motion-capture system equipped with an optoelectronic system of 15 cameras at 240 Hz placed at or around the centre of the participant's body. For static and motion capture, the marker trajectories were processed using a low-pass Butterworth filter, with a cut-off frequency of 10 Hz, for kinetic and kinematic symmetry parameters. All data processing and model building was performed using Qualisys (Software – C-motion, Göteborg, Sweden), integrated with Visual 3D software (Version 5.01.18, C-Motion, Inc., Germantown, USA).
This study consisted of a single session of data collection capture with each of the 20 asymptomatic individuals performing test-retest physical performance tests (static posture, free squat and countermovement jump) before and after lumbar spinal manipulative therapy (SMT). The participants received 5 min of task training, and performed physical tests before and after lumbar SMT intervention.The pre- and post-treatment phases were conducted with approximately 5 min between tests.
The lumbar SM was performed by a doctor on the participants using specific type of manual SM, the Diversified technique, that aims to correct the lumbar vertebral dysfunctional segments identified in the clinical assessments prior to the intervention. Thus, the athletes were instructed to lay down prone for the spinal motion palpation analysis, to evaluate the presence of dysfunction (asymptomatic), in the lumbar spine. The SM was subsequently performed with the athlete laying sideways while a correction was performed contacting the lumbar, namely on transverse process (mammillary) of the lumbar vertebrae, performing the lumbar roll technique, described by Liekens-Gillet and Bergmann.
For the purpose of this study, the kinetic symmetry was called Symmetry 1, and kinematic symmetry was called Symmetry 2, for easy comprehension. According to the biomechanical literature, this is a good representation that has been elaborated based on kinetic symmetry (force efforts between the lower limbs; ground reaction forces) parameters and kinematic symmetry (segmental organization of the whole body during all cycles of movement, and body orientations relative to connections of joint centre vectors displacements).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Symmetry of motion assessed using motion-capture analysis

Secondary outcome measures

N/A

Overall trial start date

31/08/2017

Overall trial end date

30/11/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 to 35 years
2. Asymptomatic
3. Normal clinical health condition related to lumbar spine
4. Athlete from various modalities and sportive levels

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Low back pain
2. History of body surgery
3. Contraindications of spinal manipulation
4. Any problems preventing participation in the study
5. Recent change to training routine
6. Athletic competition during the study
7. Treated with manual manipulation during the study

Recruitment start date

30/09/2017

Recruitment end date

31/10/2017

Locations

Countries of recruitment

Portugal

Trial participating centre

Department of Sports and Health, Faculty of Human Kinetics, Laboratory of Biomechanics
Estrada da costa, Cruz Quebrada
Lisboa
1499-002
Portugal

Sponsor information

Organisation

Faculty of Human Kinetics, FMH, University of Lisbon

Sponsor details

Estrada da Costa s/n
Cruz Quebrada
Dafundo
Lisbon
1499-002
Portugal
+351 214 149 100
fmh@fmh.ulisboa.pt

Sponsor type

University/education

Website

www.fmh.utl.pt

Funders

Funder type

Government

Funder name

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Alternative name(s)

Brazilian Federal Agency for the Support and Evaluation of Graduate Education, Coordination for the Improvement of Higher Education Personnel, CAPES

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Brazil

Results and Publications

Publication and dissemination plan

The outcomes of this study are expected to be presented as an original article in scientific publications, such as a high-impact peer-reviewed journal and/or congress, seminars and conferences presentations. Our biomechanics laboratory team supported the procedures and decisions to take new approaches and encouraged the submission of this report for registration in international platforms, according to manuscript publication recommendations. In this sense, we expect to follow all requirements for submission to relevant scientific journal and to share consistent and relevant results with the public in clinical, academic and sportive contexts.

IPD sharing statement:
The dataset used and/or analysed during the currently reliability study is available from the corresponding author, Bruno Araújo Procópio de Alvarenga, brunofisioquiro@hotmail.com, on reasonable request.
All participants submitted a signed informed consent form (FMH - institutional consent) that included information about the purpose of the study, its procedures, the participants’ rights and welfare, participants’ protections and the collection of data for publication.The patient information sheet is not currently available in web format; please use the contact details below to request patient information. Individual data (the biomechanical outcomes of the individual study participants showing outcomes related to performance tests symmetry between therapeutic intervention, in terms of reliability assessment, will be shared starting on 30/10/2018 upon previous communication and solicitation by responsible study contact personnel, as indicated.
Data sharing is available by request from the corresponding author. All data generated or analysed in this study are included in this submitted material.

Intention to publish date

25/11/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes