StrokeNCT04069039
Is There a Relationship Between the Ability of the Trunk and Lower Extremities and Walking Function After Stroke?
An observational study of Stroke, run by KU Leuven at 1 site in Belgium.
Trial summary
Stroke leads to impairments at different levels. Not only walking abilities are impaired after stroke but also trunk function, strength, balance and functional performance. Even in the latter phase after stroke, both walking abilities and trunk function remain restricted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Sep 2019to 15 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants suffers from a first stroke. Time after stroke can vary from two weeks untill six months after a stroke. The walking possibilities of these participants can fluctuate from walking independently on uneven ground to being unable to walk. The measurements will take place only with participants hospitalized in a rehabilitation ward.
Who may be able to join
- First stroke event.
- Residence in a rehabilitation ward.
- Two weeks until six months after a stroke event.
- Older than 18 years.
- With no comorbidities other than stroke affecting trunk function or walking ability.
- Comorbidities could be musculoskeletal problems or other neurological diseases.
- With sufficient cognitive and language capacity to perform the assessment.
Who cannot join
- Not able to give informed consent.
- Not approved informed consent.
- Subject does not understand the study procedures.
- Subject has any history of a major neurological disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Relation Between Trunk Function and Function of the Lower Extremities in Relation to Post Stroke Gait
Stroke leads to impairments at different levels. Not only walking abilities are impaired after stroke but also trunk function, strength, balance and functional performance. Even in the latter phase after stroke, both walking abilities and trunk function remain restricted.
Restoring walking function is often the main goal of rehabilitation after stroke and the focus of post-stroke physiotherapy is often on regaining walking and mobility. Reduced walking ability after stroke is a predictor for discharge to a nursing home and associated with an increased probability of death. In addition, walking endurance, measured by a six-minute walking test, has a high correlation with community reintegration after a stroke.
Read more
Both trunk function and the ability to walk are often limited after stroke. A previous study observed that a significant correlation exists between these two functions, when measured with standardized clinical measurement scales . Due to the functional relevance and the link between both functions, further investigation however is warranted. Current lack of knowledge exists in investigating the relation between trunk and gait muscle strength, and this is key for informing clinical practice. For instance, should trunk muscle strength be a significant determinant of gait function, therapy should incorporate specific training for improving trunk muscle strength.
The primary objective of the study is to investigate if trunk muscle function in combination with lower limb muscle function are significant determinants of walking ability after stroke.
Secondly, the investigators will examine if there are other determinants such as cognition, balance, spasticity, ability of performing selective movements and sensitivity of the lower extremities for walking ability.
- Conditions
- Stroke
- Keywords
- Stroke, Trunk, Lower Extremities, Gait
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
The investigators will measure walking speed by the 10 Meter Timed Walking Test .
In this test, participants have to walk for 10 meter on an even underground. The outcome will be reported in meter by seconds. This test is reliable and valid. The test will be performed twice. The first time with walking aid. The second time without walking aid if the patient is able to walk without walking aid. Each test consists of two conditions: Walking at comfortable speed and at maximum speed. Each condition will be performed three times. Patient safety will be guaranteed by a therapist walking next to the patient. Walking speed will also be registered using the GAITRite, which is a CE-marked rehabilitation device. This is an electronic single layer pressure sensitive walkway measuring temporal and spatial parameters. Its has an excellent concurrent validity for maximum walking speed with the 10 Meter Timed Walking Test (ICC=0.94, 95% CI= 0.91-0.96).
Measured: In the rehabilitation phase (2 weeks to 6 months after stroke)
Walking capacity
The functional ambulation categories (FAC) examines the level of walking capacity. This test is a six-point scale and it reflects the ability to walk independently on an all undergrounds. It ranges from non-functional walking (FAC 0) to walking independently on an unstable surface (FAC 5). FAC 1 stands for dependent walking with continuous or intermittent support from one person to help with balance and coordination. FAC 2 indicates dependent walking with intermittent support. FAC 3 represents walking with supervision and participants score a FAC 4 when able to walk independently on an even underground. A higher score represents a better outcome. At first, the investigators will evaluate in this test if the participant is able to walk with or without aid or supervision therapists. If this is possible, then the assessor evaluates if walking is possible only on an even (indoor) or uneven (outdoor) surface. In this test, the participants will be allowed to use a walking aid.
Measured: In the rehabilitation phase (2 weeks to 6 months after stroke)
Walking endurance
The investigators will evaluate the endurance of walking by using the two-minute walk test (2MWT). The participants walk for two minutes at a standardized indoor walking track and may use a walking aid. The distance in meter is the outcome of this test. Participants can take breaks without stopping the time on the stopwatch.
Measured: In the rehabilitation phase (2 weeks to 6 months after stroke)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start30 Sep 2019
- Primary completion1 Apr 2020
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Geert Verheyden, KU Leuven
- Investigators
- Geert Verheyden, Prof., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069039
- Sponsor's protocol ID
- Trunk and walking stroke KUL
- Status last verified
- Mar 2022
- First submitted
- 21 Aug 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verheyden G, Vereeck L, Truijen S, Troch M, Herregodts I, Lafosse C, Nieuwboer A, De Weerdt W. Trunk performance after stroke and the relationship with balance, gait and functional ability. Clin Rehabil. 2006 May;20(5):451-8. doi: 10.1191/0269215505cr955oa.
PubMed 16774097
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relation Between Trunk Function and Function of the Lower Extremities in Relation to Post Stroke Gait
- ClinicalTrials.gov ID
- NCT04069039
- Acronym / sponsor ID
- Trunk and walking stroke KUL
- Conditions
- Stroke
- Keywords
- Stroke, Trunk, Lower Extremities, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 28 Aug 2019 (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.
Stroke leads to impairments at different levels. Not only walking abilities are impaired after stroke but also trunk function, strength, balance and functional performance. Even in the latter phase after stroke, both walking abilities and trunk function remain restricted.
Restoring walking function is often the main goal of rehabilitation after stroke and the focus of post-stroke physiotherapy is often on regaining walking and mobility. Reduced walking ability after stroke is a predictor for discharge to a nursing home and associated with an increased probability of death. In addition, walking endurance, measured by a six-minute walking test, has a high correlation with community reintegration after a stroke.
Both trunk function and the ability to walk are often limited after stroke. A previous study observed that a significant correlation exists between these two functions, when measured with standardized clinical measurement scales . Due to the functional relevance and the link between both functions, further investigation however is warranted. Current lack of knowledge exists in investigating the relation between trunk and gait muscle strength, and this is key for informing clinical practice. For instance, should trunk muscle strength be a significant determinant of gait function, therapy should incorporate specific training for improving trunk muscle strength.
The primary objective of the study is to investigate if trunk muscle function in combination with lower limb muscle function are significant determinants of walking ability after stroke.
Secondly, the investigators will examine if there are other determinants such as cognition, balance, spasticity, ability of performing selective movements and sensitivity of the lower extremities for walking ability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants suffers from a first stroke. Time after stroke can vary from two weeks untill six months after a stroke. The walking possibilities of these participants can fluctuate from walking independently on uneven ground to being unable to walk. The measurements will take place only with participants hospitalized in a rehabilitation ward.
Key inclusion criteria (7 listed)
- First stroke event.
- Residence in a rehabilitation ward.
- Two weeks until six months after a stroke event.
- Older than 18 years.
- With no comorbidities other than stroke affecting trunk function or walking ability.
Key exclusion criteria (4 listed)
- Not able to give informed consent.
- Not approved informed consent.
- Subject does not understand the study procedures.
- Subject has any history of a major neurological disorder.
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
Walking speed
Time frame: In the rehabilitation phase (2 weeks to 6 months after stroke)
The investigators will measure walking speed by the 10 Meter Timed Walking Test . In this test, participants have to walk for 10 meter on an even underground. The outcome will be reported in meter by seconds. This test is reliable and valid. The test will be performed twice. The first time with walking aid. The second time without walking aid if the patient is able to walk without walking aid. Each test consists of two conditions: Walking at comfortable speed and at maximum speed. Each condition will be performed three times. Patient safety will be guaranteed by a therapist walking next to the patient. Walking speed will also be registered using the GAITRite, which is a CE-marked rehabilitation device. This is an electronic single layer pressure sensitive walkway measuring temporal and spatial parameters. Its has an excellent concurrent validity for maximum walking speed with the 10 Meter Timed Walking Test (ICC=0.94, 95% CI= 0.91-0.96).
Walking capacity
Time frame: In the rehabilitation phase (2 weeks to 6 months after stroke)
The functional ambulation categories (FAC) examines the level of walking capacity. This test is a six-point scale and it reflects the ability to walk independently on an all undergrounds. It ranges from non-functional walking (FAC 0) to walking independently on an unstable surface (FAC 5). FAC 1 stands for dependent walking with continuous or intermittent support from one person to help with balance and coordination. FAC 2 indicates dependent walking with intermittent support. FAC 3 represents walking with supervision and participants score a FAC 4 when able to walk independently on an even underground. A higher score represents a better outcome. At first, the investigators will evaluate in this test if the participant is able to walk with or without aid or supervision therapists. If this is possible, then the assessor evaluates if walking is possible only on an even (indoor) or uneven (outdoor) surface. In this test, the participants will be allowed to use a walking aid.
Walking endurance
Time frame: In the rehabilitation phase (2 weeks to 6 months after stroke)
The investigators will evaluate the endurance of walking by using the two-minute walk test (2MWT). The participants walk for two minutes at a standardized indoor walking track and may use a walking aid. The distance in meter is the outcome of this test. Participants can take breaks without stopping the time on the stopwatch.
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 15 Mar 2022.
- Results publication: PubMed 16774097Verheyden G, Vereeck L, Truijen S, Troch M, Herregodts I, Lafosse C, Nieuwboer A, De Weerdt W. Trunk performance after stroke and the relationship with balance, gait and functional ability. Clin Rehabil. 2006 May;20(5):451-8. doi: 10.1191/0269215505cr955oa.
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
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.
Geert Verheyden, Prof. principal investigator
KU Leuven
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, run by KU Leuven 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 7 inclusion and 4 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 15 Mar 2022. 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?
Walking speed (time frame: In the rehabilitation phase (2 weeks to 6 months after stroke)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04069039, which also lists 1 linked publication.
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 15 Mar 2022.