Interaction Between Trunk and Gait Performance in Both Healthy Adults and Stroke Patients

May 2, 2018 updated by: Tamaya Van Criekinge, Universiteit Antwerpen
The aim is to investigate the biomechanical interaction between trunk and gait performance in both healthy and stroke subjects. People after stroke often have an impaired trunk function, resulting in balance and gait disorders. Pathological movement patterns after stroke can be compared with normative data as motion capture systems provide more sensitive data to explore the interaction between trunk performance and gait in contrast to the clinical measures used in literature.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Evidence has shown that trunk performance is related to measures of balance, gait and functional ability. Yet, several aspects of trunk performance such as sitting balance, trunk muscle strength, selective trunk movements and trunk position sense are impaired after stroke. This implies that impaired trunk performance will inevitably lead to impaired postural control during activities performed while standing and walking. Nonetheless, the interaction between increased trunk performance and improvements in activities performed while standing and walking is not evident. It has previously been stated that therapy primarily induces treatment effects on the abilities at which training is specifically aimed. However, previous research has shown that additional trunk exercises improve not only trunk performance but also standing balance and mobility. Yet, the clinical outcome measures used in previous studies are not suitable to explore the relationship between trunk and gait performance and cannot explain the underlying mechanisms of the therapeutic effects. Since studies using sensitive motion analyses to investigate trunk biomechanics during gait are sparse in both healthy subjects and subjects with stroke. Data will be gathered by a Vicon analysis system (©Vicon Motion Systems Ltd., London, UK) with a measuring frequency of 100 Hz and eight infrared automated cameras (Vicon T10 cameras, 100 fps, 1 Megapixel) measured the 3D coordinates of the reflective markers. In addition, initial contact and toe off were defined based on the ankle trajectories of the reflective markers together with 3 AMTI type OR 6-7 force plates (1000 fps, 46x50x8 cm) and 1 AccuGait® (1000 fps) force plate recordings. Reflective motion trackers were attached to anatomical landmarks on the participant's body according to the standard Plug-In-Gait model. Furthermore, a 16 channel telemetric wireless EMG system (Arion Zerowire) will measure muscle activity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • RevArte Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers: community sample Stroke: Rehabilitation Hospital RevArte, primary care clinic

Description

Inclusion Criteria Stroke:

  1. haemorrhagic or ischaemic stroke diagnosis, confirmed on the basis of CT or MRI imaging;
  2. no known history of previous stroke;
  3. stroke onset within five months;
  4. patients are between 18 and 85 years of age;

Exclusion Criteria Stroke:

  1. A score of 20 or higher on the Trunk Impairment Scale which indicates normal truncal function;
  2. A score lower than two on the Functional Ambulation Categories (FAC) as patients needed to be able to ambulate without physical support to ensure that gait analysis can be executed safely;
  3. Not able to sit independently for 30 seconds on a stable surface;
  4. They suffer from other neurological and orthopaedic disorders that could influence motor performance and balance;
  5. not able to understand instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Healthy
Healthy individuals without any neurological or orthopaedic disorder that could influence motor performance and balance
Stroke
Individuals suffered from a haemorrhagic or ischaemic stroke. Diagnosis has to be confirmed on the basis of CT or MRI imaging.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Continous relative phase (of the trunk) by means of 3D full body gait analysis
Time Frame: Once, in the week of inclusion
Phase difference of the upper and lower trunk in the transverse plane which assesses trunk coordination
Once, in the week of inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lateral trunk displacements by means of 3D full body gait analysis (mm)
Time Frame: Once, in the week of inclusion
Medio-lateral movements of the upper and lower trunk in the frontal plane
Once, in the week of inclusion
Vertical trunk displacements by means of 3D full body gait analysis (mm)
Time Frame: Once, in the week of inclusion
Up- and downward movements of the upper and lower trunk in the frontal plane
Once, in the week of inclusion
Anteroposterior trunk displacements by means of 3D full body gait analysis (mm)
Time Frame: Once, in the week of inclusion
Forward and backward movements of the upper and lower trunk in the sagittal plane
Once, in the week of inclusion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Walking speed
Time Frame: Once, in the week of inclusion
(m/s)
Once, in the week of inclusion
Step length
Time Frame: Once, in the week of inclusion
(m)
Once, in the week of inclusion
Step time
Time Frame: Once, in the week of inclusion
(s)
Once, in the week of inclusion
Step width
Time Frame: Once, in the week of inclusion
(m)
Once, in the week of inclusion
% stance
Time Frame: Once, in the week of inclusion
Once, in the week of inclusion
Erector Spinae muscle activity (EMG)
Time Frame: Once, in the week of inclusion
The amplitude and timing of muscle contractions
Once, in the week of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiteit Antwerpen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rehabilitation Hospital RevArte

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Steven Truijen, Prof. Dr., Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TVC-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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