Clinical trial NCT04613661: Inter-rater Reliability of the Australian Spasticity Assessment Scale (ASAS) in Post-stroke Spasticity
Official title: Inter-rater Reliability of the Australian Spasticity Assessment Scale (ASAS) in Post-stroke Spasticity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiplegia, Spastic
Keywords: Hemiplegia
spasticity
upper limb
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic stroke patients with elbow and/or wrist and /or ankle spasticity

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Australian Spasticity Assessment Scale (ASAS)
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İlker Şengül
Study officials:
affiliation: İzmir Katip Çelebi University
name: İlker Şengül, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lundstrom 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.
citation: Wissel 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.
citation: Pierson SH. Outcome measures in spasticity management. Muscle Nerve Suppl. 1997;6:S36-60.
citation: Bohannon 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.
citation: Love 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.
citation: Calame 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.