NCT03065153

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

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, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

February 13, 2017

Last Update Submit

May 2, 2018

Conditions

Keywords

TorsoTrunk

Outcome Measures

Primary Outcomes (1)

  • Continous relative phase (of the trunk) by means of 3D full body gait analysis

    Phase difference of the upper and lower trunk in the transverse plane which assesses trunk coordination

    Once, in the week of inclusion

Secondary Outcomes (3)

  • Lateral trunk displacements by means of 3D full body gait analysis (mm)

    Once, in the week of inclusion

  • Vertical trunk displacements by means of 3D full body gait analysis (mm)

    Once, in the week of inclusion

  • Anteroposterior trunk displacements by means of 3D full body gait analysis (mm)

    Once, in the week of inclusion

Other Outcomes (6)

  • Walking speed

    Once, in the week of inclusion

  • Step length

    Once, in the week of inclusion

  • Step time

    Once, in the week of inclusion

  • +3 more other outcomes

Study Arms (2)

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.

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • A score of 20 or higher on the Trunk Impairment Scale which indicates normal truncal function;
  • 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;
  • Not able to sit independently for 30 seconds on a stable surface;
  • They suffer from other neurological and orthopaedic disorders that could influence motor performance and balance;
  • not able to understand instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RevArte Rehabilitation Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Truijen, Prof. Dr.

    Universiteit Antwerpen

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 27, 2017

Study Start

April 1, 2015

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations