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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065153
• Other study ID #: TVC-2
• Status: Completed
• Start date: April 1, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: May 2018
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Healthy
• Stroke

Locations

Country	Name	City	State
Belgium	RevArte Rehabilitation Hospital	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Rehabilitation Hospital RevArte

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Walking speed	(m/s)	Once, in the week of inclusion
Other	Step length	(m)	Once, in the week of inclusion
Other	Step time	(s)	Once, in the week of inclusion
Other	Step width	(m)	Once, in the week of inclusion
Other	% stance		Once, in the week of inclusion
Other	Erector Spinae muscle activity (EMG)	The amplitude and timing of muscle contractions	Once, in the week of inclusion
Primary	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	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
Secondary	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
Secondary	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