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

February 20, 2026 updated by: Zeynep Demir, Fatih Sultan Mehmet Training and Research Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients aged 18-80 years who have been clinically and radiologically diagnosed with ischemic or hemorrhagic stroke and who developed upper extremity hypertonia will be recruited from the Physical Medicine and Rehabilitation Clinic of SBU Fatih Sultan Mehmet Training and Research Hospital. Participants will be in Brunnstrom stages 2-6 and clinically stable at the time of assessment. The study population consists of individuals in the chronic or subacute post-stroke phase undergoing routine rehabilitation follow-up.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline assessment and repeat assessment within 2-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline assessment
Correlation Between HAT Subtypes and Clinical Recovery Stages
Time Frame: Baseline assessment
To analyze the correlation between HAT classifications and clinical recovery stages.
Baseline assessment
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.
Baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Investigators

  • Principal Investigator: Zeynep Demir, MD, Fatih Sultan Mehmet Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDA-VLDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to institutional and ethical restrictions. The study involves clinical data collected from patients, and data sharing is not permitted under the current ethics committee approval and institutional policies. Only aggregated and anonymized results will be published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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