StrokeSCALANCT03077399
Validation Study of SCALA, Scale for Lateropulsion
A study testing SCALA in people with Stroke, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Development and clinical validation of SCALA, a new rating scale for lateropulsion after stroke. A monocentric clinical study including 78 post-stroke individuals and 30 patients without stroke and/or healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- SCALA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 26 Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: postural disorders other than stroke or body geometry disorders (e.g. limb amputation, severe deformity, bone fracture, trunk deformity with deviation of C7 greater than 30mm) interfering with balance, acute vertigo, history of severe psychiatric disease, medical instability, dementia diagnosed, and severe understanding deficits limiting assessments.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of SCALA, a New Rating Scale for Assessing Lateropulsion After Stroke
Development and clinical validation of SCALA, a new rating scale for lateropulsion after stroke. A monocentric clinical study including 78 post-stroke individuals and 30 patients without stroke and/or healthy volunteers.
In order to analyze the SCALA's content validity, a Delphi-type consensus process was applied prior to clinical validation. The Delphi process, including 20 international experts, has given rise to the version of the scale to be tested clinically (SCALA-V1; Paper in preparation).
Read the detailed description
The protocol aims to develop and validate a new clinical rating scale assessing lateropulsion after stroke. The project is driven by the need to have a tool that better meets clinometric properties than the 2 main existing scales, the Scale for Contraversive Pushing (SCP) and the Burke Lateropulsion Scale (BLS), and by the need to have a unicist scale to assess all components of lateropulsion (i.e. body tilt, active pushing by non-paretic limbs and resistance to passive correction) regardless the mechanisms or the severity of lateropulsion and the side of the stroke lesion.
The initial version (version 0) of the scale has been developed by our team in Grenoble (SCALA-V0). In a first step, an online expert consensus process (Delphi method) will give rise to a version 1 (SCALA-V1), considered as generally accepted by the scientific community.
The SCALA-V1 will be validated in a monocentric clinical study. 78 individuals with stroke and 30 individuals without stroke and/or healthy controls will be included.
All subjects will be comprehensively assessed during 3 weeks. During the first week will be performed many assessments used in routine in our center. These assessments will serve to describe participants and ensure that our series is comparable to others of the literature. These assessments which are not considered as outcome are: age, sex, height, weight, manual laterality, comorbidity, apraxia, executive function deficits, retropulsion, depression, and autonomy. Several other clinical assessments will also be performed during the first week, this time to serve as outcomes: stroke lesion characteristics, motor weakness, spasticity, spatial neglect, anosognosia, aphasia, hemianopsia, hypoesthesia, visual verticality, balance and gait disorders. During the second week, lateropulsion by SCALA-V1, verticality perception and spatial representation will be assessed to determine their inter-rater reliability. During the last week, mass distribution on lower limbs in frontal plan during standing position and body orientation in frontal plan during sitting position, standing position and sit-to-stand will be assessed.
Editorial valorization of the clinical trial: This study will be valorized by several papers, one concerning clinometric properties of SCALA-V1 (reliability …), other(s) paper(s) about the understanding of lateropulsion, and clinometric properties of the devices assessing vertical perception and body orientation.
- Conditions
- Stroke
- Being tested
- SCALA
- Keywords
- lateropulsion, stroke, Pusher syndrome
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCALADevice
All items of SCALA are applied
| Study group | Role | What they receive |
|---|---|---|
| stroke | Experimental | stroke patients, application of SCALA Receives: Device: SCALA |
| control | Experimental | Healthy individuals (patients without stroke), application of SCALA Receives: Device: SCALA |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCALA Reliability
Inter-rater reliability, internal consistency, measurement error of SCALA
Measured: week 2 (assessed twice +/-2d)
Secondary outcomes (8)
Influence of vision on lateropulsion
Comparison of scores of items performed with and without vision
Measured: week 2
Interest of the condition without vision on the lateropulsion diagnosis from the SCALA total score.
Comparison of proportion of individuals with a lateropulsion by using the total score of SCALA based on all items (with and without vision) and that of individuals with a lateropulsion by using the total score of SCALA based only on items with vision
Measured: week 2
Evaluation of SCALA feasibility
Influence of sensory-motor, language and cognitive deficits, severity of balance and gait disorders, and stroke features (type and localization) on the time required to complete SCALA; Descriptive statistics on items judged as "not applicable"
Measured: Week 2
To improve the understanding of mechanisms underpinning lateropulsion
Relation between the total score or subscores of SCALA, and stroke lesion characteristics, verticality perception, representation of longitudinal body axis in lying position, body orientation in frontal plan, weight-bearing asymmetry, and awareness of deficits.
Measured: weeks 1,2 and 3
Reliability of supplementary instrumental assessments of lateropulsion
Inter-rater reliability of longitudinal body axis representation and postural verticality perception
Measured: Week 2 (assessed twice +/-2d)
Criterion validity of SCALA
Comparison to Scale for Contraversive Pushing and Burke Lateropulsion Scale, which currently are considered as gold-standards to assess lateropulsion.
Measured: Weeks 1 and 2
Descriptive analysis of data of individuals with stroke
Descriptive analysis of data
Measured: Weeks 1, 2 and 3
Descriptive analysis of data of healthy controls
Descriptive analysis of data including normality ranges.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 Sep 2022
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study is a monocentric observational clinical study. During the first week, the assessments used in routine in our center will be performed. During the second week, the assessments of lateropulsion by SCALA-V1, postural verticality perception in sitting and the representation of longitudinal body axis in lying position will be performed twice, 2 days apart, by 2 different raters in order to determine their inter-rater reliability. During the third week, mass distribution on lower limbs in frontal plan during standing position and body orientation in frontal plan during sitting position, standing position and sit-to-stand will be assessed.
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominic Pérennou, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077399
- Sponsor's protocol ID
- 38RC16.088
- Acronym
- SCALA
- Status last verified
- May 2025
- First submitted
- 7 Oct 2016
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of SCALA, a New Rating Scale for Assessing Lateropulsion After Stroke
- ClinicalTrials.gov ID
- NCT03077399
- Acronym / sponsor ID
- SCALA / 38RC16.088
- Conditions
- Stroke
- Keywords
- lateropulsion, stroke, Pusher syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 13 Mar 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.
Development and clinical validation of SCALA, a new rating scale for lateropulsion after stroke. A monocentric clinical study including 78 post-stroke individuals and 30 patients without stroke and/or healthy volunteers.
In order to analyze the SCALA's content validity, a Delphi-type consensus process was applied prior to clinical validation. The Delphi process, including 20 international experts, has given rise to the version of the scale to be tested clinically (SCALA-V1; Paper in preparation).
Detailed description
The protocol aims to develop and validate a new clinical rating scale assessing lateropulsion after stroke. The project is driven by the need to have a tool that better meets clinometric properties than the 2 main existing scales, the Scale for Contraversive Pushing (SCP) and the Burke Lateropulsion Scale (BLS), and by the need to have a unicist scale to assess all components of lateropulsion (i.e. body tilt, active pushing by non-paretic limbs and resistance to passive correction) regardless the mechanisms or the severity of lateropulsion and the side of the stroke lesion.
The initial version (version 0) of the scale has been developed by our team in Grenoble (SCALA-V0). In a first step, an online expert consensus process (Delphi method) will give rise to a version 1 (SCALA-V1), considered as generally accepted by the scientific community.
The SCALA-V1 will be validated in a monocentric clinical study. 78 individuals with stroke and 30 individuals without stroke and/or healthy controls will be included.
All subjects will be comprehensively assessed during 3 weeks. During the first week will be performed many assessments used in routine in our center. These assessments will serve to describe participants and ensure that our series is comparable to others of the literature. These assessments which are not considered as outcome are: age, sex, height, weight, manual laterality, comorbidity, apraxia, executive function deficits, retropulsion, depression, and autonomy. Several other clinical assessments will also be performed during the first week, this time to serve as outcomes: stroke lesion characteristics, motor weakness, spasticity, spatial neglect, anosognosia, aphasia, hemianopsia, hypoesthesia, visual verticality, balance and gait disorders. During the second week, lateropulsion by SCALA-V1, verticality perception and spatial representation will be assessed to determine their inter-rater reliability. During the last week, mass distribution on lower limbs in frontal plan during standing position and body orientation in frontal plan during sitting position, standing position and sit-to-stand will be assessed.
Editorial valorization of the clinical trial: This study will be valorized by several papers, one concerning clinometric properties of SCALA-V1 (reliability …), other(s) paper(s) about the understanding of lateropulsion, and clinometric properties of the devices assessing vertical perception and body orientation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a monocentric observational clinical study. During the first week, the assessments used in routine in our center will be performed. During the second week, the assessments of lateropulsion by SCALA-V1, postural verticality perception in sitting and the representation of longitudinal body axis in lying position will be performed twice, 2 days apart, by 2 different raters in order to determine their inter-rater reliability. During the third week, mass distribution on lower limbs in frontal plan during standing position and body orientation in frontal plan during sitting position, standing position and sit-to-stand will be assessed.
| Arm | Type | Receives |
|---|---|---|
| stroke | Experimental | Device: SCALAstroke patients, application of SCALA |
| control | Experimental | Device: SCALAHealthy individuals (patients without stroke), application of SCALA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Exclusion Criteria: postural disorders other than stroke or body geometry disorders (e.g. limb amputation, severe deformity, bone fracture, trunk deformity with deviation of C7 greater than 30mm) interfering with balance, acute vertigo, history of severe psychiatric disease, medical instability, dementia diagnosed, and severe understanding deficits limiting assessments.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SCALAAll items of SCALA are applied | Device | control, stroke |
Primary outcome
SCALA Reliability
Time frame: week 2 (assessed twice +/-2d)
Inter-rater reliability, internal consistency, measurement error of SCALA
8 secondary outcomes
Influence of vision on lateropulsion
Time frame: week 2
Interest of the condition without vision on the lateropulsion diagnosis from the SCALA total score.
Time frame: week 2
Evaluation of SCALA feasibility
Time frame: Week 2
To improve the understanding of mechanisms underpinning lateropulsion
Time frame: weeks 1,2 and 3
Reliability of supplementary instrumental assessments of lateropulsion
Time frame: Week 2 (assessed twice +/-2d)
Criterion validity of SCALA
Time frame: Weeks 1 and 2
Descriptive analysis of data of individuals with stroke
Time frame: Weeks 1, 2 and 3
Descriptive analysis of data of healthy controls
Time frame: Day 1
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 21 May 2025.
- Individual participant dataSharing planned: No
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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.
Dominic Pérennou, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCALA in people with Stroke, run by University Hospital, Grenoble at 1 site in France.
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 1 inclusion and 0 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 21 May 2025. 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 France. 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?
SCALA Reliability (time frame: week 2 (assessed twice +/-2d)). 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 21 May 2025.