Validity and Reliability of the Hypertonia Assessment Tool (HAT) in Stroke Patients
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2026
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
February 17, 2026
CompletedFirst Posted
Study publicly available on registry
February 24, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedFebruary 24, 2026
February 1, 2026
3 months
February 17, 2026
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline assessment and repeat assessment within 2-5 days
Secondary Outcomes (3)
Association Between HAT Classification and Motor Function Level
Baseline assessment
Correlation Between HAT Subtypes and Clinical Recovery Stages
Baseline assessment
Discriminative Effect of HAT-Defined Hypertonia Subtypes on Motor Function
Baseline assessment
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Istanbul, 34752, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zeynep Demir, MD
Fatih Sultan Mehmet Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
February 17, 2026
First Posted
February 24, 2026
Study Start
March 1, 2026
Primary Completion
June 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.