NCT07267442

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress94%
Jan 2025Jun 2026

Study Start

First participant enrolled

January 10, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Expected
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

November 23, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

HypertoniaMotor DisorderReliability and Validity

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (1)

Children with motor disorders

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • as voluntary participation in the study,
  • a diagnosis of a neuromotor disorder under the age of 18,
  • sufficient cognitive ability to follow verbal commands

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Motor DisordersMuscle Hypertonia

Condition Hierarchy (Ancestors)

Mental DisordersNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bulent Elbasan, Prof. Dr.

    Gazi University

    STUDY CHAIR

Central Study Contacts

Hidayet Cuha, PhD(c)

CONTACT

Esra Serdaroglu, MD, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PT, PhD(c)

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 5, 2025

Study Start

January 10, 2025

Primary Completion

January 10, 2026

Study Completion (Estimated)

June 10, 2026

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations