StrokeSWEAT²NCT02708888
Stroke Walking Explained After Trunk Training
A study testing Trunk training and Cognitive exercises in people with Stroke, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The aim of SWEAT² study is to further explore the effects of additional customized trunk exercises on clinical and biomechanical gait performance. Despite of the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Trunk training and Cognitive exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2016to Aug 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Haemorrhagic or ischaemic stroke diagnosis has to be confirmed by the consultant appointed at the rehabilitation centre on the basis of CT or MRI imaging
- Patients with a history of first stroke
- Stroke onset within five months
- Patients who are able to sit independently for 30 seconds on a stable surface
- Hospitalized in the rehabilitation hospital RevArte
- Written informed consent
Who cannot join
- A score of 20 or higher on the Trunk Impairment Scale
- A score of 2 or lower on the Functional Ambulation Categories
- Patients suffering from other neurological and orthopaedic disorders that could influence motor performance and balance
- Patients not able to understand instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Additional Trunk Exercises on Gait Performance: a Randomised Controlled Trial
The aim of SWEAT² study is to further explore the effects of additional customized trunk exercises on clinical and biomechanical gait performance. Despite of the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. The findings of this study might lead to new scientific insights in the importance of the trunk during gait rehabilitation in people suffering from stroke submitted to a rehabilitation hospital.
Read the detailed description
Objective: To examine the effects of additional trunk exercises on gait performance via clinical and biomechanical assessments in patients receiving inpatient rehabilitation after stroke.
Design: The design of this study is an assessor-blinded randomized controlled trial. Prior to evaluation, participants will be randomly allocated to either the experimental or control group by means of concealed envelopes. The number of patients required for this study was calculated a priori to ensure sufficient statistical power. Analysis showed that a sample size of 30 patients in each group was necessary to detect a difference (ES1) with 80 % using a two-tailed hypothesis (with significance of p=0.05).
Intervention: All patients will receive a multidisciplinary conventional stroke rehabilitation program provided by the rehabilitation staff. The control group will receive a series of cognitive exercises focusing on aspects of memory (visual, auditory, and working memory), attention (sustained attention and selective attention), and executive functioning (planning and problem-solving). The additional training of the trunk training group focuses on trunk muscle strength, coordination and selective movements. The training program will consist of task-specific movements of the upper and lower part of the trunk both in supine and sitting position on stable and unstable surfaces (physio balls). The following trunk exercises will be performed: bridging, reaching, lower/upper trunk rotations, lower/upper trunk lateral flexion, upper/lower trunk flexion, ...
Outcome measures:
- Tinetti Test
- Gait parameters recorded during 3D-Full body gait analysis: Gait analysis was performed at the M²OCEAN movement analysis laboratory (Multidisciplinary Motor Centre Antwerp, University of Antwerp, Antwerp, Edegem). VICON analysis system (©Vicon Motion Systems Ltd., London, UK) which is the golden standard for 3D motion analysis. Eight infrared automated cameras (Vicon T10 cameras, 100 fps, 1 Megapixel) measured the 3D coordinates of reflective motion trackers. Two video cameras recorded the walking pattern of the participants in the sagittal and frontal plane. In addition, initial contact and toe off were measured 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. Subsequently, the movement analysis lab is equipped with a 16 channel telemetric wireless electromyographic (EMG) system (Arion Zerowire) which measures muscle activity. Recordings where analysed using the Vicon Nexus 1.8.5. software. Step time parameters and gait kinematics were filtered (Butterworth filter) and further processed in Matlab® (The MathWorks, Inc., Natick, Massachusetts, U.S.A.).
- Trunk Impairment Scale, Barthel Index
Follow-up. One month post intervention patients will be again subjected to clinical and biomechanical assessment to measure the sustainability of trunk exercises over time.
- Conditions
- Stroke
- Being tested
- Trunk training, Cognitive exercises
- Keywords
- Trunk, Biomechanical Phenomena, Gait, Electromyography, Rehabilitation, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk trainingOther
The experimental group receives 16 hours of additional trunk training (4 days/week, 4 weeks) focusing on trunk muscle strength, coordination and selective movements executed on stable and unstable surfaces.
Cognitive exercisesOther
The control group will be receiving the same amount of repetitive cognitive exercises within arm's range to ensure no anticipatory postural adjustments of the trunk.
| Study group | Role | What they receive |
|---|---|---|
| Trunk training | Experimental | Exercises: Core stability training Receives: Other: Trunk training |
| Cognitive exercises | Sham comparator | Exercises: The RevArte Visual Search Test (RVST) of Lafosse et al (2013) and the Visuospatial Neglect Test Battery (VNTB) of Vaes et al. (2015) Receives: Other: Cognitive exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Tinetti Performance Oriented Mobility Assessment
Tinetti Test measures gait and balance on a 3-point ordinal scale ranging from 0 to 2. The maximum score of the total Tinetti is 28 points, whereby a maximum of 12 and 16 points can be obtained for gait and balance subscales.
Measured: week 0, week 5, and week 9
Secondary outcomes (3)
The change in temporal gait parameters
The following temporal gait parameters will be investigated: stride length (m), step length (m), and step width (m). These parameters examine the difference in distance.
Measured: week 0, week 5, and week 9
The change in kinematic parameters of the trunk, hip, knee, and ankle
The following kinematic parameters will be assessed: mean angle during stance (°), mean angle during swing (°), minimum angle during stance (°), maximal angle during stance (°), minimal angle during swing (°), maximal angle during swing (°), angle at foot strike (°), angle at foot off (°), range of motion (°). These parameters examine the difference in joint angles.
Measured: week 0, week 5, and week 9
The change is muscle activity of the trunk and lower legs during walking
Muscle activity of the trunk and lower limbs will be registered by means of surface EMG. The amplitude and timing of muscle contractions will be assessed.
Measured: week 0, week 5, and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 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
- Tamaya Van Criekinge, Msc, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708888
- Sponsor's protocol ID
- TVC-1
- Acronym
- SWEAT²
- Status last verified
- Feb 2019
- First submitted
- 2 Mar 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Van Criekinge T, Hallemans A, Herssens N, Lafosse C, Claes D, De Hertogh W, Truijen S, Saeys W. SWEAT2 Study: Effectiveness of Trunk Training on Gait and Trunk Kinematics After Stroke: A Randomized Controlled Trial. Phys Ther. 2020 Aug 31;100(9):1568-1581. doi: 10.1093/ptj/pzaa110.
PubMed 32542356Van Criekinge T, Saeys W, Hallemans A, Vereeck L, De Hertogh W, Van de Walle P, Vaes N, Lafosse C, Truijen S. Effectiveness of additional trunk exercises on gait performance: study protocol for a randomized controlled trial. Trials. 2017 Jun 2;18(1):249. doi: 10.1186/s13063-017-1989-1.
PubMed 28578679
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Additional Trunk Exercises on Gait Performance: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02708888
- Acronym / sponsor ID
- SWEAT² / TVC-1
- Conditions
- Stroke
- Keywords
- Trunk, Biomechanical Phenomena, Gait, Electromyography, Rehabilitation, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital RevArte
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Mar 2016 (estimated)
- 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 SWEAT² study is to further explore the effects of additional customized trunk exercises on clinical and biomechanical gait performance. Despite of the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. The findings of this study might lead to new scientific insights in the importance of the trunk during gait rehabilitation in people suffering from stroke submitted to a rehabilitation hospital.
Detailed description
Objective: To examine the effects of additional trunk exercises on gait performance via clinical and biomechanical assessments in patients receiving inpatient rehabilitation after stroke.
Design: The design of this study is an assessor-blinded randomized controlled trial. Prior to evaluation, participants will be randomly allocated to either the experimental or control group by means of concealed envelopes. The number of patients required for this study was calculated a priori to ensure sufficient statistical power. Analysis showed that a sample size of 30 patients in each group was necessary to detect a difference (ES1) with 80 % using a two-tailed hypothesis (with significance of p=0.05).
Intervention: All patients will receive a multidisciplinary conventional stroke rehabilitation program provided by the rehabilitation staff. The control group will receive a series of cognitive exercises focusing on aspects of memory (visual, auditory, and working memory), attention (sustained attention and selective attention), and executive functioning (planning and problem-solving). The additional training of the trunk training group focuses on trunk muscle strength, coordination and selective movements. The training program will consist of task-specific movements of the upper and lower part of the trunk both in supine and sitting position on stable and unstable surfaces (physio balls). The following trunk exercises will be performed: bridging, reaching, lower/upper trunk rotations, lower/upper trunk lateral flexion, upper/lower trunk flexion, ...
Outcome measures:
- Tinetti Test
- Gait parameters recorded during 3D-Full body gait analysis: Gait analysis was performed at the M²OCEAN movement analysis laboratory (Multidisciplinary Motor Centre Antwerp, University of Antwerp, Antwerp, Edegem). VICON analysis system (©Vicon Motion Systems Ltd., London, UK) which is the golden standard for 3D motion analysis. Eight infrared automated cameras (Vicon T10 cameras, 100 fps, 1 Megapixel) measured the 3D coordinates of reflective motion trackers. Two video cameras recorded the walking pattern of the participants in the sagittal and frontal plane. In addition, initial contact and toe off were measured 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. Subsequently, the movement analysis lab is equipped with a 16 channel telemetric wireless electromyographic (EMG) system (Arion Zerowire) which measures muscle activity. Recordings where analysed using the Vicon Nexus 1.8.5. software. Step time parameters and gait kinematics were filtered (Butterworth filter) and further processed in Matlab® (The MathWorks, Inc., Natick, Massachusetts, U.S.A.).
- Trunk Impairment Scale, Barthel Index
Follow-up. One month post intervention patients will be again subjected to clinical and biomechanical assessment to measure the sustainability of trunk exercises over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trunk training | Experimental | Other: Trunk trainingExercises: Core stability training |
| Cognitive exercises | Sham comparator | Other: Cognitive exercisesExercises: The RevArte Visual Search Test (RVST) of Lafosse et al (2013) and the Visuospatial Neglect Test Battery (VNTB) of Vaes et al. (2015) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Haemorrhagic or ischaemic stroke diagnosis has to be confirmed by the consultant appointed at the rehabilitation centre on the basis of CT or MRI imaging
- Patients with a history of first stroke
- Stroke onset within five months
- Patients who are able to sit independently for 30 seconds on a stable surface
- Hospitalized in the rehabilitation hospital RevArte
Key exclusion criteria (4 listed)
- A score of 20 or higher on the Trunk Impairment Scale
- A score of 2 or lower on the Functional Ambulation Categories
- Patients suffering from other neurological and orthopaedic disorders that could influence motor performance and balance
- Patients 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trunk trainingThe experimental group receives 16 hours of additional trunk training (4 days/week, 4 weeks) focusing on trunk muscle strength, coordination and selective movements executed on stable and unstable surfaces. | Other | Trunk training |
| Cognitive exercisesThe control group will be receiving the same amount of repetitive cognitive exercises within arm's range to ensure no anticipatory postural adjustments of the trunk. | Other | Cognitive exercises |
Primary outcome
The change in Tinetti Performance Oriented Mobility Assessment
Time frame: week 0, week 5, and week 9
Tinetti Test measures gait and balance on a 3-point ordinal scale ranging from 0 to 2. The maximum score of the total Tinetti is 28 points, whereby a maximum of 12 and 16 points can be obtained for gait and balance subscales.
3 secondary outcomes
The change in temporal gait parameters
Time frame: week 0, week 5, and week 9
The change in kinematic parameters of the trunk, hip, knee, and ankle
Time frame: week 0, week 5, and week 9
The change is muscle activity of the trunk and lower legs during walking
Time frame: week 0, week 5, and week 9
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 19 Feb 2019.
- Derived from this study: PubMed 32542356Van Criekinge T, Hallemans A, Herssens N, Lafosse C, Claes D, De Hertogh W, Truijen S, Saeys W. SWEAT2 Study: Effectiveness of Trunk Training on Gait and Trunk Kinematics After Stroke: A Randomized Controlled Trial. Phys Ther. 2020 Aug 31;100(9):1568-1581. doi: 10.1093/ptj/pzaa110.
- Derived from this study: PubMed 28578679Van Criekinge T, Saeys W, Hallemans A, Vereeck L, De Hertogh W, Van de Walle P, Vaes N, Lafosse C, Truijen S. Effectiveness of additional trunk exercises on gait performance: study protocol for a randomized controlled trial. Trials. 2017 Jun 2;18(1):249. doi: 10.1186/s13063-017-1989-1.
- Individual participant dataSharing planned: Undecided
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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.
Tamaya Van Criekinge, Msc principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trunk training and Cognitive exercises in people with Stroke, 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 6 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 19 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
The change in Tinetti Performance Oriented Mobility Assessment (time frame: week 0, week 5, and week 9). 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 NCT02708888, which also lists 2 linked publications.
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 19 Feb 2019.