Hemiplegia, SpasticNCT04613661
Inter-rater Reliability of the Australian Spasticity Assessment Scale (ASAS) in Post-stroke Spasticity
An observational study of Hemiplegia, Spastic, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The reliability of the Australian Spasticity Assessment Scale (ASAS) has been reported to be not high enough in adult patients with acquired brain damage. The low number of patients and the heterogeneous study population have been reported as important limitations in the reliability study of this measure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegia, Spastic
- What is being tested?
- Australian Spasticity Assessment Scale
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2020to 17 Dec 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: Chronic stroke patients with elbow and/or wrist and /or ankle spasticity
Who may be able to join
- Chronic stroke (> 6 months)
- Fist stroke
- Increased tone according to the Modified Ashworth Scale in at least one of the elbow, wrist, and ankle
- Stability of spasticity for the last 3 months
Who cannot join
- Increased tone due to causes other than stroke (traumatic brain injury, spinal cord injury, multiple sclerosis, motor neuron disease, etc.)
- Acute or subacute stroke (≤6 months)
- Recurrent stroke attacks
- Presence of contracture and/or moderate to severe pain in the joints to be assessed (elbow, wrist, and ankle)
- Botulinum toxin injection in the last three months
- History of neurolysis for spasticity (alcohol or phenol)
- History of surgery for spasticity
- Initiation of a new drug for spasticity, or a change in drug dose
Trial locations and contacts
1 site in 1 country.
About this study
The reliability of the Australian Spasticity Assessment Scale (ASAS) has been reported to be not high enough in adult patients with acquired brain damage. The low number of patients and the heterogeneous study population have been reported as important limitations in the reliability study of this measure. Therefore, the reliability of the ASAS needs to be confirmed in stroke patients with spasticity. This study aims to investigate the inter-rater reliability of the ASAS in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).
Read the detailed description
Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex due to upper motor neuron lesion. The prevalence of post-stroke spasticity is between 17-40%. In the assessment of spasticity, although biomechanical and neurophysiological methods provide quantitative data, semi-quantitative methods are mostly used clinically. The most frequently used spasticity measures are the Modified Ashworth Scale and the Modified Tardieu Scale. However, these methods have significant disadvantages. Therefore, the search for more reliable clinical measures continues. One of the newly developed clinical scales is called the Australian Spasticity Assessment Scale (ASAS). Although ASAS has been reported to have a high level of reliability in children with cerebral palsy, the same has not been detected in adult patients with acquired brain damage. The low number of patients and the heterogeneous study population have been reported as two of the important limitations in the reliability study of this measure.
In this study, researchers aim to investigate the inter-rater reliability of the ASAS in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).
- Conditions
- Hemiplegia, Spastic
- Being tested
- Australian Spasticity Assessment Scale
- Keywords
- Hemiplegia, spasticity, upper limb
- Medical subject headings
- Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Australian Spasticity Assessment ScaleOther
Australian Spasticity Assessment Scale is a clinical measure to assess the severity of spasticity
| Study group | Role | What they receive |
|---|---|---|
| Researcher 1 | The first researcher assessing elbow, wrist, and ankle spasticity, respectively Receives: Other: Australian Spasticity Assessment Scale | |
| Researcher 2 | The second researcher assessing elbow, wrist, and ankle spasticity, respectively Receives: Other: Australian Spasticity Assessment Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Australian Spasticity Assessment Scale (ASAS)
The ASAS is an ordinal scale with five levels (0, 1, 2, 3, 4). The severity of spasticity increases as the level-ups.The contracture is assessed separately. Level 0 means no catch on rapid passive stretch (no spasticity), and level 4 means that the body part is fixed on the rapid passive stretch but moves on the slow passive stretch. In level 1, a catch followed by a release occurs on the rapid passive stretch. In level 2, the catch is in the second half of the range, and there is a resistance in the remaining range of motion. In level 3, the catch is in the first half of the range, and there is a resistance in the remaining range of motion.
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start20 Oct 2020
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hemiplegia, SpasticStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilker şengül, Izmir Katip Celebi University
- Investigators
- İlker Şengül, M.D., Principal investigator, İzmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613661
- Sponsor's protocol ID
- 2020-GOKAE-0450
- Status last verified
- Feb 2022
- First submitted
- 23 Oct 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.
PubMed 7192811Lundstrom E, Terent A, Borg J. Prevalence of disabling spasticity 1 year after first-ever stroke. Eur J Neurol. 2008 Jun;15(6):533-9. doi: 10.1111/j.1468-1331.2008.02114.x. Epub 2008 Mar 18.
PubMed 18355307Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448.
PubMed 23319481Pierson SH. Outcome measures in spasticity management. Muscle Nerve Suppl. 1997;6:S36-60.
PubMed 9826982Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PubMed 3809245Love S, Gibson N, Smith N, Bear N, Blair E; Australian Cerebral Palsy Register Group. Interobserver reliability of the Australian Spasticity Assessment Scale (ASAS). Dev Med Child Neurol. 2016 Feb;58 Suppl 2:18-24. doi: 10.1111/dmcn.13000. Epub 2016 Jan 14.
PubMed 26762706Calame A, Singer B. Inter- and Intra-Rater Reliability of the Australian Spasticity Assessment Scale in Adults with Acquired Brain Injury. Open Journal of Therapy and Rehabilitation. 2015;3:77-86.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-rater Reliability of the Australian Spasticity Assessment Scale (ASAS) in Post-stroke Spasticity
- ClinicalTrials.gov ID
- NCT04613661
- Acronym / sponsor ID
- 2020-GOKAE-0450
- Conditions
- Hemiplegia, Spastic
- Keywords
- Hemiplegia, spasticity, upper limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 3 Nov 2020 (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 reliability of the Australian Spasticity Assessment Scale (ASAS) has been reported to be not high enough in adult patients with acquired brain damage. The low number of patients and the heterogeneous study population have been reported as important limitations in the reliability study of this measure. Therefore, the reliability of the ASAS needs to be confirmed in stroke patients with spasticity. This study aims to investigate the inter-rater reliability of the ASAS in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).
Detailed description
Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex due to upper motor neuron lesion. The prevalence of post-stroke spasticity is between 17-40%. In the assessment of spasticity, although biomechanical and neurophysiological methods provide quantitative data, semi-quantitative methods are mostly used clinically. The most frequently used spasticity measures are the Modified Ashworth Scale and the Modified Tardieu Scale. However, these methods have significant disadvantages. Therefore, the search for more reliable clinical measures continues. One of the newly developed clinical scales is called the Australian Spasticity Assessment Scale (ASAS). Although ASAS has been reported to have a high level of reliability in children with cerebral palsy, the same has not been detected in adult patients with acquired brain damage. The low number of patients and the heterogeneous study population have been reported as two of the important limitations in the reliability study of this measure.
In this study, researchers aim to investigate the inter-rater reliability of the ASAS in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Researcher 1 | – | Other: Australian Spasticity Assessment ScaleThe first researcher assessing elbow, wrist, and ankle spasticity, respectively |
| Researcher 2 | – | Other: Australian Spasticity Assessment ScaleThe second researcher assessing elbow, wrist, and ankle spasticity, respectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic stroke patients with elbow and/or wrist and /or ankle spasticity
Key inclusion criteria (4 listed)
- Chronic stroke (> 6 months)
- Fist stroke
- Increased tone according to the Modified Ashworth Scale in at least one of the elbow, wrist, and ankle
- Stability of spasticity for the last 3 months
Key exclusion criteria (8 listed)
- Increased tone due to causes other than stroke (traumatic brain injury, spinal cord injury, multiple sclerosis, motor neuron disease, etc.)
- Acute or subacute stroke (≤6 months)
- Recurrent stroke attacks
- Presence of contracture and/or moderate to severe pain in the joints to be assessed (elbow, wrist, and ankle)
- Botulinum toxin injection in the last three months
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 |
|---|---|---|
| Australian Spasticity Assessment ScaleAustralian Spasticity Assessment Scale is a clinical measure to assess the severity of spasticity | Other | Researcher 1, Researcher 2 |
Primary outcome
Australian Spasticity Assessment Scale (ASAS)
Time frame: Through study completion, an average of 2 year
The ASAS is an ordinal scale with five levels (0, 1, 2, 3, 4). The severity of spasticity increases as the level-ups.The contracture is assessed separately. Level 0 means no catch on rapid passive stretch (no spasticity), and level 4 means that the body part is fixed on the rapid passive stretch but moves on the slow passive stretch. In level 1, a catch followed by a release occurs on the rapid passive stretch. In level 2, the catch is in the second half of the range, and there is a resistance in the remaining range of motion. In level 3, the catch is in the first half of the range, and there is a resistance in the remaining range of motion.
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 Feb 2022.
- Background: PubMed 7192811Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.
- Background: PubMed 18355307Lundstrom E, Terent A, Borg J. Prevalence of disabling spasticity 1 year after first-ever stroke. Eur J Neurol. 2008 Jun;15(6):533-9. doi: 10.1111/j.1468-1331.2008.02114.x. Epub 2008 Mar 18.
- Background: PubMed 23319481Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448.
- Background: PubMed 9826982Pierson SH. Outcome measures in spasticity management. Muscle Nerve Suppl. 1997;6:S36-60.
- Background: PubMed 3809245Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
- Background: PubMed 26762706Love S, Gibson N, Smith N, Bear N, Blair E; Australian Cerebral Palsy Register Group. Interobserver reliability of the Australian Spasticity Assessment Scale (ASAS). Dev Med Child Neurol. 2016 Feb;58 Suppl 2:18-24. doi: 10.1111/dmcn.13000. Epub 2016 Jan 14.
- BackgroundCalame A, Singer B. Inter- and Intra-Rater Reliability of the Australian Spasticity Assessment Scale in Adults with Acquired Brain Injury. Open Journal of Therapy and Rehabilitation. 2015;3:77-86.
- 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.
İlker Şengül, M.D. principal investigator
İzmir Katip Çelebi University
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 Hemiplegia, Spastic, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 8 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 Feb 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 Turkey (Türkiye). 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?
Australian Spasticity Assessment Scale (ASAS) (time frame: Through study completion, an average of 2 year). 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 NCT04613661, which also lists 7 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 15 Feb 2022.