- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267442
Turkish Translation , Validity and Reliability of the Hypertonia Assessment Tool in Children With Motor Disorders
Study Overview
Status
Conditions
Detailed Description
Among children with omotor disorders, particularly those with cerebral palsy, abnormalities in muscle tone are among the most common clinical symptoms. Damage occurring in various structures such as the thalamus, cerebral cortex, and basal ganglia can adversely affect muscle tone. Hypertonia is defined as an abnormal increase in resistance to externally imposed movement about a joint. It leads to limitations in activity participation, loss of motor control, and reduced quality of life. Hypertonia, which causes impairments in gross motor skills such as walking, stair climbing, and crawling, negatively affects the quality of life in childhood.
Muscle tone disorders in childhood can be classified into three main types: spasticity, dystonia, and rigidity. Spasticity is defined as a velocity-dependent increase in muscle tone associated with hyperexcitability of the tonic stretch reflex. Dystonia is a movement disorder characterized by sustained or intermittent involuntary muscle contractions that cause twisting, repetitive movements, abnormal postures, or a combination of these. Rigidity refers to bidirectional, velocity-independent resistance to passive movement, which may involve simultaneous co-contraction of agonist and antagonist muscles. In some cases, more than one type of tone abnormality may coexist.
Several assessment tools have been developed to evaluate different subtypes of hypertonia or general increases in tone. The most commonly used methods in clinical and research settings include the Modified Ashworth Scale (MAS), the Modified Tardieu Scale (MTS), and the Barry-Albright Dystonia Scale (BADS). While these scales evaluate different aspects of hypertonia, they do not distinguish between its subtypes. The Hypertonia Assessment Tool (HAT) was developed to address the need for a single instrument capable of differentiating among hypertonia subtypes. Introduced to the literature by Fehlings et al. in 2010, the HAT has been shown to be a valid and reliable tool for assessing the three subtypes of hypertonia in children with cerebral palsy.
The HAT involves observing an extremity joint during passive stretch and voluntary movement to detect increased tone or resistance. The scale consists of seven items-two assessing spasticity, two rigidity, and three dystonia. It can differentiate hypertonia subtypes in both upper and lower extremities and takes approximately five minutes to administer per limb. Studies in various patient populations have reported moderate to good levels of validity and reliability.
Translating psychometrically robust assessment tools into Turkish will expand the number of instruments available for clinical and research use in our native language. Therefore, the aim of this study was to translate the Hypertonia Assessment Tool into Turkish and to evaluate its validity and reliability in children with motor disorders.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hidayet Cuha, PhD(c)
- Phone Number: +90 534 646 01 06
- Email: hcuha@kastamonu.edu.tr
Study Contact Backup
- Name: Esra Serdaroglu, MD, Assoc. Prof.
- Phone Number: +90 312 202 6090
- Email: esras@gazi.edu.tr
Study Locations
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Ankara, Turkey (Türkiye)
- Recruiting
- Gazi University
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Contact:
- Hidayet Cuha, PhD(c)
- Phone Number: +90 534 646 01 06
- Email: hidayet.cuha@gazi.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- as voluntary participation in the study,
- a diagnosis of a neuromotor disorder under the age of 18,
- sufficient cognitive ability to follow verbal commands
Exclusion Criteria:
- Patients with any other systemic disease,
- Who had received botulinum toxin A injections or undergone surgery within the past three months,
- Be unable to follow verbal instructions
- Medical treatment had been modified within the last month
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children with motor disorders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Hypertonia Assessment Tool
Time Frame: The patient, diagnosed by a pediatric neurologist, is evaluated by the researcher. A second evaluation is repeated one week later after a follow-up examination to ensure test-retest reliability.
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The Hypertonia Assessment Tool (HAT) was developed to address the need for a single instrument capable of evaluating different subtypes of increased muscle tone within one assessment battery.
The HAT involves observing a patient's limb during a targeted passive stretch and during voluntary movement to assess increased tone or resistance.
The scale consists of seven items in total: two assess spasticity, two assess rigidity, and three assess dystonia.
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The patient, diagnosed by a pediatric neurologist, is evaluated by the researcher. A second evaluation is repeated one week later after a follow-up examination to ensure test-retest reliability.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Bulent Elbasan, Prof. Dr., Gazi University
Publications and helpful links
General Publications
- Marsico P, Frontzek-Weps V, Balzer J, van Hedel HJ. Hypertonia Assessment Tool. J Child Neurol. 2017 Jan;32(1):132-138. doi: 10.1177/0883073816671681. Epub 2016 Oct 15.
- Jethwa A, Mink J, Macarthur C, Knights S, Fehlings T, Fehlings D. Development of the Hypertonia Assessment Tool (HAT): a discriminative tool for hypertonia in children. Dev Med Child Neurol. 2010 May;52(5):e83-7. doi: 10.1111/j.1469-8749.2009.03483.x.
- Haberfehlner H, Goudriaan M, Bonouvrie LA, Jansma EP, Harlaar J, Vermeulen RJ, van der Krogt MM, Buizer AI. Instrumented assessment of motor function in dyskinetic cerebral palsy: a systematic review. J Neuroeng Rehabil. 2020 Mar 5;17(1):39. doi: 10.1186/s12984-020-00658-6.
- Hadders-Algra M. Early Diagnostics and Early Intervention in Neurodevelopmental Disorders-Age-Dependent Challenges and Opportunities. J Clin Med. 2021 Feb 19;10(4):861. doi: 10.3390/jcm10040861.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024 - 1944
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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