Cerebral PalsyNCT07091201
Validity and Reliability The Foot-taping Test in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
In spastic cerebral palsy, there are interrelated neuromuscular deficits that can affect ankle joint control, including impaired selective voluntary motor control, muscle weakness, spasticity, and shortened muscle-tendon units. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Dec 2025
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with spastic cerebral palsy from two different Special Education Institutions in the Aegean Region will be included in the study. All participants and their guardians will be informed about the aims of the study and the evaluation procedure. Written informed consent will be obtained from all participants and their guardians before the study. The study will be conducted by the principles of the Helsinki Declaration.
Who may be able to join
- ≤3 diagnosed with spastic cerebral palsy according to the Gross Motor Function and Classification System
- Be between 6 and 18 years of age
- Be diagnosed with spastic diplegic or spastic hemiplegic cerebral palsy
- Have a GMFCS score ≤3
- Have a Communication Function Classification System (CFCS) score ≤2
- Have a Modified Ashworth Scale (MASH) score ≤3 for lower limb muscles
- Be able to walk 10 metres independently
- Be able to follow verbal commands
Who cannot join
- The presence of serious hearing, vision or cognitive problems,
- The presence of nerve block injections or orthopaedic surgery within the last 6 months (such as Botox injections or muscle lengthening surgery)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Orthopedic Prosthesis-Orthosis, Afyonkarahisar Health Sciences University, Atatürk Health Services Vocational School
Afyonkarahisar, 03030
About this study
Official title: The Evaluation of the Validity and Reliability The Foot-taping Test in Children With Cerebral Palsy
In spastic cerebral palsy, there are interrelated neuromuscular deficits that can affect ankle joint control, including impaired selective voluntary motor control, muscle weakness, spasticity, and shortened muscle-tendon units. As a result, it is important to assess ankle joint control in children with spastic cerebral palsy. Clinicians need valid, reliable, and practical methods to assess ankle joint control. The aim of this study is to evaluate the validity and reliability of the Foot-taping Test in children with spastic cerebral palsy.
Read the detailed description
Cerebral palsy is an umbrella term that refers to a permanent group of movement, posture, and/or motor function disorders caused by a non-progressive lesion or abnormality in the developing immature brain. In spastic cerebral palsy, there are interrelated neuromuscular deficits that can affect ankle joint control, impaired selective voluntary motor control, muscle weakness, spasticity, and shortened muscle-tendon units. As a result, it is important to assess ankle joint control in children with spastic cerebral palsy. Clinicians need valid, reliable, and practical methods to assess ankle joint control. The aim of this study is to evaluate the validity and reliability of the Foot-taping Test in children with spastic cerebral palsy. This study will conduct Department of Orthopedic Prosthesis-Orthosis at Afyonkarahisar Health Sciences University Atatürk Health Services Vocational School. Children aged 6-18 with spastic cerebral palsy (diparetic and hemiparetic) from two different special education institutions in the Aegean Region will be included in the study.
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot-Taping Test
For this test, the participant will be asked to strike the floor as quickly as possible for 10 seconds with each bare foot. The number of times the participant taps their foot on the ground within 10 seconds is recorded. The higher the number of times the participant taps their foot, the better their ankle control.
Measured: Two assessors will administer the SAVT to the participants on the first day, two hours apart (first test). The duration of the test is 5 minutes. The retest will be administered 7-10 days after the first test.
Active Ankle Range of Motion
The participant will be placed supine, and the head of the fibula, lateral malleolus, head of the fifth metatarsal, and base of the fifth metatarsal will be marked. A digital camera will be used to photograph the range of motion of active dorsiflexion and plantar flexion. ImageJ, a software, will be used to measure the ROMs from the images.
Measured: Two assessors will administer the SAVT to the participants on the first day, two hours apart (first test). The duration of the test is 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start15 Mar 2024
- Primary completion15 May 2025
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdal Horata, Afyonkarahisar Health Sciences University
- Investigators
- ERDAL HORATA, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091201
- Sponsor's protocol ID
- 2024/02-19
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Validity and Reliability The Foot-taping Test in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07091201
- Acronym / sponsor ID
- 2024/02-19
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, spasticity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 29 Jul 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.
In spastic cerebral palsy, there are interrelated neuromuscular deficits that can affect ankle joint control, including impaired selective voluntary motor control, muscle weakness, spasticity, and shortened muscle-tendon units. As a result, it is important to assess ankle joint control in children with spastic cerebral palsy. Clinicians need valid, reliable, and practical methods to assess ankle joint control. The aim of this study is to evaluate the validity and reliability of the Foot-taping Test in children with spastic cerebral palsy.
Detailed description
Cerebral palsy is an umbrella term that refers to a permanent group of movement, posture, and/or motor function disorders caused by a non-progressive lesion or abnormality in the developing immature brain. In spastic cerebral palsy, there are interrelated neuromuscular deficits that can affect ankle joint control, impaired selective voluntary motor control, muscle weakness, spasticity, and shortened muscle-tendon units. As a result, it is important to assess ankle joint control in children with spastic cerebral palsy. Clinicians need valid, reliable, and practical methods to assess ankle joint control. The aim of this study is to evaluate the validity and reliability of the Foot-taping Test in children with spastic cerebral palsy. This study will conduct Department of Orthopedic Prosthesis-Orthosis at Afyonkarahisar Health Sciences University Atatürk Health Services Vocational School. Children aged 6-18 with spastic cerebral palsy (diparetic and hemiparetic) from two different special education institutions in the Aegean Region will be included in the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with spastic cerebral palsy from two different Special Education Institutions in the Aegean Region will be included in the study. All participants and their guardians will be informed about the aims of the study and the evaluation procedure. Written informed consent will be obtained from all participants and their guardians before the study. The study will be conducted by the principles of the Helsinki Declaration.
Key inclusion criteria (8 listed)
- ≤3 diagnosed with spastic cerebral palsy according to the Gross Motor Function and Classification System
- Be between 6 and 18 years of age
- Be diagnosed with spastic diplegic or spastic hemiplegic cerebral palsy
- Have a GMFCS score ≤3
- Have a Communication Function Classification System (CFCS) score ≤2
Key exclusion criteria (2 listed)
- The presence of serious hearing, vision or cognitive problems,
- The presence of nerve block injections or orthopaedic surgery within the last 6 months (such as Botox injections or muscle lengthening surgery)
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
Foot-Taping Test
Time frame: Two assessors will administer the SAVT to the participants on the first day, two hours apart (first test). The duration of the test is 5 minutes. The retest will be administered 7-10 days after the first test.
For this test, the participant will be asked to strike the floor as quickly as possible for 10 seconds with each bare foot. The number of times the participant taps their foot on the ground within 10 seconds is recorded. The higher the number of times the participant taps their foot, the better their ankle control.
Active Ankle Range of Motion
Time frame: Two assessors will administer the SAVT to the participants on the first day, two hours apart (first test). The duration of the test is 10 minutes.
The participant will be placed supine, and the head of the fibula, lateral malleolus, head of the fifth metatarsal, and base of the fifth metatarsal will be marked. A digital camera will be used to photograph the range of motion of active dorsiflexion and plantar flexion. ImageJ, a software, will be used to measure the ROMs from the images.
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 29 Jul 2025.
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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. This study is not recruiting at the moment.
ERDAL HORATA, PhD principal investigator
Afyonkarahisar Health Sciences 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 Cerebral Palsy, run by Afyonkarahisar Health Sciences 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 8 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot-Taping Test (time frame: Two assessors will administer the SAVT to the participants on the first day, two hours apart (first test). The duration of the test is 5 minutes. The retest will be administered 7-10 days after the first test.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2025.