StrokeNCT03065153
Interaction Between Trunk and Gait Performance in Both Healthy Adults and Stroke Patients
An observational study of Stroke and Healthy, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Healthy, Gait, Hemiplegic
- How many people
- 114 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2015to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers: community sample Stroke: Rehabilitation Hospital RevArte, primary care clinic
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Healthy, Gait, Hemiplegic
- Keywords
- Torso, Trunk
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Once, in the week of inclusion
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Once, in the week of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start1 Apr 2015
- Primary completion1 Jul 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital RevArte
- Responsible party
- Principal investigator, Tamaya Van Criekinge, Universiteit Antwerpen
- Investigators
- Steven Truijen, Prof. Dr., Study chair, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065153
- Sponsor's protocol ID
- TVC-2
- Status last verified
- May 2018
- First submitted
- 13 Feb 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Trunk and Gait Performance in Both Healthy Adults and Stroke Patients
- ClinicalTrials.gov ID
- NCT03065153
- Acronym / sponsor ID
- TVC-2
- Conditions
- Stroke, Healthy, Gait, Hemiplegic
- Keywords
- Torso, Trunk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital RevArte
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers: community sample Stroke: Rehabilitation Hospital RevArte, primary care clinic
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Lateral trunk displacements by means of 3D full body gait analysis (mm)
Time frame: 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
Anteroposterior trunk displacements by means of 3D full body gait analysis (mm)
Time frame: Once, in the week of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: Undecided
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Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Truijen, Prof. Dr. study chair
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Healthy, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continous relative phase (of the trunk) by means of 3D full body gait analysis (time frame: Once, in the week of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.