StrokeNCT07429383
Validity and Reliability of the Hypertonia Assessment Tool (HAT) in Stroke Patients
An observational study of Stroke and Hypertonia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hypertonia, Dystonia
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Istanbul, 34752
Pınar Akpınar, MD, +905057877442, pinar.pinarakpinar@gmail.com
About this study
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.
Read the 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.
- Conditions
- Stroke, Hypertonia, Dystonia, Rigidity, Hemiplegia
- Keywords
- hypertonia, dystonia, rigidity, reliability, validity, hemiplegia, spasticity, stroke
- Medical subject headings
- Stroke, Muscle Hypertonia, Dystonia, Muscle Rigidity, Hemiplegia, Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity and Reliability of the Hypertonia Assessment Tool (HAT) in Adult Post-Stroke Patients
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.
Measured: Baseline assessment and repeat assessment within 2-5 days
Secondary outcomes (3)
Association Between HAT Classification and Motor Function Level
To evaluate the relationship between Hypertonia Assessment Tool (HAT) results and post-stroke motor function levels.
Measured: Baseline assessment
Correlation Between HAT Subtypes and Clinical Recovery Stages
To analyze the correlation between HAT classifications and clinical recovery stages.
Measured: Baseline assessment
Discriminative Effect of HAT-Defined Hypertonia Subtypes on Motor Function
To investigate the ability of the HAT to distinguish the differential effects of various hypertonia subtypes on motor function.
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Demir, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Zeynep Demir, MD, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429383
- Sponsor's protocol ID
- HDA-VLDT
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Hypertonia Assessment Tool (HAT) in Stroke Patients
- ClinicalTrials.gov ID
- NCT07429383
- Acronym / sponsor ID
- HDA-VLDT
- Conditions
- Stroke, Hypertonia, Dystonia, Rigidity, Hemiplegia
- Keywords
- hypertonia, dystonia, rigidity, reliability, validity, hemiplegia, spasticity, stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Association Between HAT Classification and Motor Function Level
Time frame: Baseline assessment
Correlation Between HAT Subtypes and Clinical Recovery Stages
Time frame: Baseline assessment
Discriminative Effect of HAT-Defined Hypertonia Subtypes on Motor Function
Time frame: Baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeynep Demir, MD principal investigator
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hypertonia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Demir, medical doctor (+905398399989, zeynepdemir.dr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.