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

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: Completed
• Conditions: Stroke; Healthy; Gait, Hemiplegic

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: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lateral trunk displacements by means of 3D full body gait analysis (mm)	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)	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)	Forward and backward movements of the upper and lower trunk in the sagittal plane	Once, in the week of inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	(m/s)	Once, in the week of inclusion
Step length	(m)	Once, in the week of inclusion
Step time	(s)	Once, in the week of inclusion
Step width	(m)	Once, in the week of inclusion
% stance		Once, in the week of inclusion
Erector Spinae muscle activity (EMG)	The amplitude and timing of muscle contractions	Once, in the week of inclusion

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: Rehabilitation Hospital RevArte
• Investigators: Study Chair: Steven Truijen, Prof. Dr., Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Trunk; Torso
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Gait Disorders, Neurologic
• Other Study ID 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