Motor DisorderNCT07267442
Turkish Translation , Validity and Reliability of the Hypertonia Assessment Tool in Children With Motor Disorders
An observational study of Motor Disorder and Reliability and Validity, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Translating batteries with good psychometric properties into Turkish will increase the number of assessment batteries we can use in our language for clinical and academic studies. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Motor Disorder, Reliability and Validity, Hypertonia
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 10 Jun 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This methodological study was designed as a Turkish language adaptation, validity, and reliability study. It will be conducted at the Developmental Physiotherapy and Pediatric Rehabilitation Unit of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, between January 15, 2025, and January 15, 2026. Children with neuromotor disorders diagnosed by a pediatric neurologist and attending routine clinical follow-up visits will be recruited through convenience sampling. The total sample size was determined as 70 participants, corresponding to ten times the number of items in the scale. Children whose parents provide written and verbal informed consent will be included in the study.
Who may be able to join
- as voluntary participation in the study,
- a diagnosis of a neuromotor disorder under the age of 18,
- sufficient cognitive ability to follow verbal commands
Who cannot join
- 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
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, 1 recruiting
- Recruiting
Gazi University
Ankara
Hidayet Cuha, PhD(c), +90 534 646 01 06, hidayet.cuha@gazi.edu.tr
About this study
Translating batteries with good psychometric properties into Turkish will increase the number of assessment batteries we can use in our language for clinical and academic studies. Therefore, the aim of our study was to verify the validity, reliability, and translation into Turkish of the Hypertonus Assessment Tool for children with motor disorders.
Read the 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.
- Conditions
- Motor Disorder, Reliability and Validity, Hypertonia
- Keywords
- Hypertonia, Motor Disorder, Reliability and Validity
- Medical subject headings
- Motor Disorders, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with motor disorders | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertonia Assessment Tool
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start10 Jan 2025
- Primary completion10 Jan 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Motor DisorderStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Hidayet Cuha, Kastamonu University
- Investigators
- Bulent Elbasan, Prof. Dr., Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267442
- Sponsor's protocol ID
- 2024 - 1944
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All IPD collected throughout the trial, only IPD used in the results publication.
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.
PubMed 27742862Jethwa 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.
PubMed 20540176Haberfehlner 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.
PubMed 32138731Hadders-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.
PubMed 33669727
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Translation , Validity and Reliability of the Hypertonia Assessment Tool in Children With Motor Disorders
- ClinicalTrials.gov ID
- NCT07267442
- Acronym / sponsor ID
- 2024 - 1944
- Conditions
- Motor Disorder, Reliability and Validity, Hypertonia
- Keywords
- Hypertonia, Motor Disorder, Reliability and Validity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
Translating batteries with good psychometric properties into Turkish will increase the number of assessment batteries we can use in our language for clinical and academic studies. Therefore, the aim of our study was to verify the validity, reliability, and translation into Turkish of the Hypertonus Assessment Tool for children with motor disorders.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with motor disorders | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This methodological study was designed as a Turkish language adaptation, validity, and reliability study. It will be conducted at the Developmental Physiotherapy and Pediatric Rehabilitation Unit of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, between January 15, 2025, and January 15, 2026. Children with neuromotor disorders diagnosed by a pediatric neurologist and attending routine clinical follow-up visits will be recruited through convenience sampling. The total sample size was determined as 70 participants, corresponding to ten times the number of items in the scale. Children whose parents provide written and verbal informed consent will be included in the study.
Key inclusion criteria (3 listed)
- as voluntary participation in the study,
- a diagnosis of a neuromotor disorder under the age of 18,
- sufficient cognitive ability to follow verbal commands
Key exclusion criteria (4 listed)
- 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
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
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.
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.
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 5 Dec 2025.
- Results publication: PubMed 27742862Marsico 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.
- Results publication: PubMed 20540176Jethwa 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.
- Results publication: PubMed 32138731Haberfehlner 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.
- Results publication: PubMed 33669727Hadders-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.
- Individual participant dataSharing planned: Undecided. All IPD collected throughout the trial, only IPD used in the results publication.
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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.
Bulent Elbasan, Prof. Dr. study chair
Gazi University
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 Motor Disorder and Reliability and Validity, run by Kastamonu University 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. 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 Hidayet Cuha, PhD(c) (+90 534 646 01 06, hcuha@kastamonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07267442, which also lists 4 linked publications.
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 5 Dec 2025.