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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFatih Sultan Mehmet Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

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

Secondary outcomes

1

Association Between HAT Classification and Motor Function Level

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

Time frame
Baseline assessment
2

Correlation Between HAT Subtypes and Clinical Recovery Stages

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

Time frame
Baseline assessment
3

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.

Time frame
Baseline assessment

Other outcomes

Sponsors and contacts

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