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Validity and Reliability of the Hypertonia Assessment Tool (HAT) in Stroke Patients

Validity and Reliability of the Hypertonia Assessment Tool (HAT) in Stroke Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07429383
Enrollment
60
Registered
2026-02-24
Start date
2026-03-01
Completion date
2026-10-01
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia, Hemiplegia, Hypertonia, Rigidity, Stroke

Keywords

hypertonia, dystonia, rigidity, reliability, validity, hemiplegia, spasticity, stroke

Brief summary

In this study, the validity and reliability of the Hypertonia Assessment Tool (HAT), which has previously been validated in the pediatric cerebral palsy (CP) population, will be evaluated in adult individuals who have experienced a stroke. The HAT is a specific clinical instrument designed to differentiate subtypes of hypertonia, including spasticity, dystonia, and rigidity. Accurate classification of hypertonia subtypes following stroke is crucial for guiding rehabilitation strategies. However, the HAT has not yet been validated in the adult post-stroke population. This study will be conducted at the Physical Medicine and Rehabilitation Clinic of SBU Fatih Sultan Mehmet Training and Research Hospital. The study aims to evaluate the validity and reliability of the HAT for use in adults with stroke.

Detailed description

Stroke is defined by the World Health Organization (WHO) as a neurological disorder characterized by the sudden onset of focal cerebral dysfunction of presumed vascular origin, lasting at least 24 hours, with no apparent cause other than vascular pathology. It is the second most common cause of death worldwide after cardiovascular diseases and the leading cause of long-term disability in adults. Hemiplegia develops in approximately 75-80% of individuals who experience a stroke, resulting not only in motor impairments but also in a significant decline in quality of life. A substantial proportion of post-stroke motor impairments is attributable to hypertonia. Hypertonia is a clinical condition characterized by increased muscle tone that limits voluntary motor control and functional movement. The most common subtypes of hypertonia are spasticity, dystonia, and rigidity, each differing in etiopathogenesis, clinical course, and response to treatment. Although dystonia is less frequently recognized compared to spasticity, it may have a considerable impact on functional limitation. Therefore, accurate differentiation of hypertonia subtypes is of great importance for individualized rehabilitation planning, prognostic evaluation, and monitoring treatment effectiveness. Several clinical assessment tools have been developed to evaluate hypertonia. The Modified Ashworth Scale (MAS), the Tardieu Scale, the Burke-Fahn-Marsden Dystonia Rating Scale (BFM) and the Barry-Albright Dystonia Scale (BADS) are commonly used to assess the severity of hypertonia, spasticity, and dystonic postures. However, these instruments focus solely on the degree of muscle tone and do not differentiate between hypertonia subtypes. None of these measures provide a structured framework for systematically distinguishing clinically distinct subtypes such as spasticity, dystonia, and rigidity. Consequently, uncertainties may arise in both diagnosis and treatment planning. The Hypertonia Assessment Tool (HAT) was developed in this context as a structured and specific clinical instrument designed to differentiate spasticity, dystonia, and rigidity. The validity and reliability of the HAT have been demonstrated in the pediatric cerebral palsy (CP) population. However, no validity or reliability study of the HAT has been conducted in adult individuals with stroke, either nationally or in the international literature. Recent systematic reviews on hypertonia assessment have highlighted the insufficient differentiation of spasticity and dystonia in adult populations and the limited use of discriminative clinical tools such as the HAT. This limitation may hinder the implementation of subtype-specific rehabilitation strategies. Therefore, evaluating the validity and reliability of the HAT in the adult stroke population will add a new dimension to clinical practice by enabling more accurate identification of hypertonia subtypes and contributing to individualized rehabilitation planning. Furthermore, this study will address an important gap in both national and international literature and will provide the first dataset regarding the use of the HAT in adult stroke patients.

Interventions

None listed

Sponsors

Fatih Sultan Mehmet Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age 18 years and older * Clinically and radiologically confirmed diagnosis of stroke (ischemic or -hemorrhagic) * Brunnstrom stage between 2 and 6 * Presence of post-stroke hypertonia (spasticity, dystonia, or rigidity) * Cognitive level sufficient to cooperate with assessments (Mini-Mental State Examination (MMSE) score \>23 or equivalent clinical evaluation) * Provision of written informed consent

Exclusion criteria

* Age under 18 years * Presence of severe accompanying neurodegenerative diseases (e.g., Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis) * Presence of primary musculoskeletal disorders affecting motor performance (e.g., rheumatologic diseases, fractures) * Brunnstrom stage of 1 * Severe aphasia, impaired consciousness, or cognitive deficits preventing effective communication and cooperation * Any psychiatric disorder that may interfere with study participation

Design outcomes

Primary

MeasureTime frameDescription
Validity and Reliability of the Hypertonia Assessment Tool (HAT) in Adult Post-Stroke PatientsBaseline assessment and repeat assessment within 2-5 daysThe primary outcome of this study is to evaluate the validity and reliability of the Hypertonia Assessment Tool (HAT) in adult post-stroke patients. Test-retest (intra-rater) reliability will be assessed by repeating the evaluation with the same examiner within 2-5 days, and inter-rater reliability will be examined through assessments conducted by two different examiners on the same day using statistical methods such as the Intraclass Correlation Coefficient (ICC). Validity will be determined by analyzing the relationship between HAT results and established clinical scales, including the Modified Ashworth Scale and Modified Tardieu Scale for spasticity, the Fugl-Meyer Motor Assessment for motor function, the Brunnstrom Staging Scale for recovery stages, and the Burke-Fahn-Marsden Dystonia Rating Scale for dystonia severity.

Secondary

MeasureTime frameDescription
Association Between HAT Classification and Motor Function LevelBaseline assessmentTo evaluate the relationship between Hypertonia Assessment Tool (HAT) results and post-stroke motor function levels.
Correlation Between HAT Subtypes and Clinical Recovery StagesBaseline assessmentTo analyze the correlation between HAT classifications and clinical recovery stages.
Discriminative Effect of HAT-Defined Hypertonia Subtypes on Motor FunctionBaseline assessmentTo investigate the ability of the HAT to distinguish the differential effects of various hypertonia subtypes on motor function.

Countries

Turkey (Türkiye)

Contacts

CONTACTZeynep Demir, medical doctor
zeynepdemir.dr@gmail.com+905398399989
CONTACTPınar Akpınar, medical doctor
pinar.pinarakpinar@gmail.com+905057877442
PRINCIPAL_INVESTIGATORZeynep Demir, MD

Fatih Sultan Mehmet Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026