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NCT Number: NCT07429383

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Validity and Reliability of the Hypertonia Assessment Tool (HAT) in Adult Post-Stroke Patients

    Time frame: Baseline assessment and repeat assessment within 2-5 days

    The 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 outcomes

  1. Association Between HAT Classification and Motor Function Level

    Time frame: Baseline assessment

    To evaluate the relationship between Hypertonia Assessment Tool (HAT) results and post-stroke motor function levels.

  2. Correlation Between HAT Subtypes and Clinical Recovery Stages

    Time frame: Baseline assessment

    To analyze the correlation between HAT classifications and clinical recovery stages.

  3. Discriminative Effect of HAT-Defined Hypertonia Subtypes on Motor Function

    Time frame: Baseline assessment

    To investigate the ability of the HAT to distinguish the differential effects of various hypertonia subtypes on motor function.

Study contacts

Contact information is provided by the study sponsor or research team.

Pınar Akpınar, medical doctor

CONTACT

[email protected]

+905057877442

Zeynep Demir, medical doctor

CONTACT

[email protected]

+905398399989

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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