NCT04613661

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

October 23, 2020

Last Update Submit

February 14, 2022

Conditions

Keywords

Hemiplegiaspasticityupper limb

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 2 year

Study Arms (2)

Researcher 1

The first researcher assessing elbow, wrist, and ankle spasticity, respectively

Other: Australian Spasticity Assessment Scale

Researcher 2

The second researcher assessing elbow, wrist, and ankle spasticity, respectively

Other: Australian Spasticity Assessment Scale

Interventions

Australian Spasticity Assessment Scale is a clinical measure to assess the severity of spasticity

Researcher 1Researcher 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic stroke patients with elbow and/or wrist and /or ankle spasticity

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İlker Şengül

Izmir, 35360, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 7192811BACKGROUND
  • 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.

    PMID: 18355307BACKGROUND
  • 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.

    PMID: 23319481BACKGROUND
  • Pierson SH. Outcome measures in spasticity management. Muscle Nerve Suppl. 1997;6:S36-60.

    PMID: 9826982BACKGROUND
  • 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.

    PMID: 3809245BACKGROUND
  • 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.

    PMID: 26762706BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

HemiplegiaMuscle Spasticity

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular Manifestations

Study Officials

  • İlker Şengül, M.D.

    İzmir Katip Çelebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 3, 2020

Study Start

October 20, 2020

Primary Completion

December 17, 2021

Study Completion

December 17, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations