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

Sponsor
Universiteit Antwerpen (Other)
Overall Status
Completed
CT.gov ID
NCT03065153
Collaborator
Rehabilitation Hospital RevArte (Other)
114
1
32
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    114 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Interaction Between Trunk and Gait Performance in Both Healthy Adults and Stroke Patients
    Actual Study Start Date :
    Apr 1, 2015
    Actual Primary Completion Date :
    Jul 1, 2017
    Actual Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Continous relative phase (of the trunk) by means of 3D full body gait analysis [Once, in the week of inclusion]

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

    Secondary Outcome Measures

    1. Lateral trunk displacements by means of 3D full body gait analysis (mm) [Once, in the week of inclusion]

      Medio-lateral movements of the upper and lower trunk in the frontal plane

    2. Vertical trunk displacements by means of 3D full body gait analysis (mm) [Once, in the week of inclusion]

      Up- and downward movements of the upper and lower trunk in the frontal plane

    3. Anteroposterior trunk displacements by means of 3D full body gait analysis (mm) [Once, in the week of inclusion]

      Forward and backward movements of the upper and lower trunk in the sagittal plane

    Other Outcome Measures

    1. Walking speed [Once, in the week of inclusion]

      (m/s)

    2. Step length [Once, in the week of inclusion]

      (m)

    3. Step time [Once, in the week of inclusion]

      (s)

    4. Step width [Once, in the week of inclusion]

      (m)

    5. % stance [Once, in the week of inclusion]

    6. Erector Spinae muscle activity (EMG) [Once, in the week of inclusion]

      The amplitude and timing of muscle contractions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RevArte Rehabilitation Hospital Edegem Antwerp Belgium 2650

    Sponsors and Collaborators

    • Universiteit Antwerpen
    • Rehabilitation Hospital RevArte

    Investigators

    • Study Chair: Steven Truijen, Prof. Dr., Universiteit Antwerpen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tamaya Van Criekinge, Principal Investigator, Universiteit Antwerpen
    ClinicalTrials.gov Identifier:
    NCT03065153
    Other Study ID Numbers:
    • TVC-2
    First Posted:
    Feb 27, 2017
    Last Update Posted:
    May 3, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tamaya Van Criekinge, Principal Investigator, Universiteit Antwerpen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2018