NCT07091201

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

July 17, 2025

Last Update Submit

July 27, 2025

Conditions

Keywords

cerebral palsyspasticity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • ≤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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedic Prosthesis-Orthosis, Afyonkarahisar Health Sciences University, Atatürk Health Services Vocational School

Afyonkarahisar, 03030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ERDAL HORATA, PhD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Assistant Professor

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 29, 2025

Study Start

March 15, 2024

Primary Completion

May 15, 2025

Study Completion

December 15, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations