StrokeNCT03731299
Muscle Synergies After Stroke
An observational study of Stroke, run by Universiteit Antwerpen.
Trial summary
The aim of this systematic review was to determine the number of muscle synergies and the distribution of muscle weightings in stroke patients during gait. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 114 participants
- Where
- No sites listed yet
- 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 18 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; 4 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.
About this study
Official title: Are Spatial and Temporal Muscle Synergy Modules Related to Functional Ability After Stroke?
The aim of this systematic review was to determine the number of muscle synergies and the distribution of muscle weightings in stroke patients during gait.
Read the detailed description
The aim of this systematic review was to determine the number of muscle synergies and the distribution of muscle weightings in stroke patients during gait. Although literature has suggested that merging of synergies occurs after stroke and that a larger number of is associated with increased motor function if compared with healthy adults. IIt is still unknown if this hypothesis is also relevant when comparing different functional levels within a stroke population and what functional impact of altered synergies on walking behavior is.
- Conditions
- Stroke
- Keywords
- muscle synergies, gait, functional ability
- Medical subject headings
- Stroke
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 |
|---|---|---|
| Stroke | Individuals suffered from a haemorrhagic or ischaemic stroke. Diagnosis has to be confirmed on the basis of CT or MRI imaging. | |
| Healthy adults | Healthy individuals without any neurological or orthopaedic disorder that could influence motor performance and balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of muscle synergies derived by non-negative matrix factorization
Spatial characteristic of muscle synergy compared to healthy adults: the amount of synergies during walking in stroke subjects, the amount of muscles in one synergie and which muscles in one synergy
Measured: Once, in the week of inclusion
Secondary outcomes (1)
Distribution of muscle synerigies derived by non-negative matrix factorization
Temporal characteristic of muscle synergy compared to healthy adults: When are these synergies active during the gait cycle (100%).
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 posted6 Nov 2018
- 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
- Responsible party
- Principal investigator, Tamaya Van Criekinge, Universiteit Antwerpen
- Investigators
- Steven Truijen, Prof., Study director, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731299
- Sponsor's protocol ID
- TVC3
- Status last verified
- Nov 2018
- First submitted
- 26 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Spatial and Temporal Muscle Synergy Modules Related to Functional Ability After Stroke?
- ClinicalTrials.gov ID
- NCT03731299
- Acronym / sponsor ID
- TVC3
- Conditions
- Stroke
- Keywords
- muscle synergies, gait, functional ability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 6 Nov 2018 (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 of this systematic review was to determine the number of muscle synergies and the distribution of muscle weightings in stroke patients during gait.
Detailed description
The aim of this systematic review was to determine the number of muscle synergies and the distribution of muscle weightings in stroke patients during gait. Although literature has suggested that merging of synergies occurs after stroke and that a larger number of is associated with increased motor function if compared with healthy adults. IIt is still unknown if this hypothesis is also relevant when comparing different functional levels within a stroke population and what functional impact of altered synergies on walking behavior is.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | –Individuals suffered from a haemorrhagic or ischaemic stroke. Diagnosis has to be confirmed on the basis of CT or MRI imaging. |
| Healthy adults | – | –Healthy individuals without any neurological or orthopaedic disorder that could influence motor performance and balance |
Who may qualify
- Ages
- 18 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 (3 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; 4 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
Amount of muscle synergies derived by non-negative matrix factorization
Time frame: Once, in the week of inclusion
Spatial characteristic of muscle synergy compared to healthy adults: the amount of synergies during walking in stroke subjects, the amount of muscles in one synergie and which muscles in one synergy
1 secondary outcome
Distribution of muscle synerigies derived by non-negative matrix factorization
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 6 Nov 2018.
- Individual participant dataSharing planned: No
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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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. study director
Universiteit Antwerpen
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Universiteit Antwerpen.
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 3 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Amount of muscle synergies derived by non-negative matrix factorization (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 6 Nov 2018.