NCT05696535

Brief Summary

Although spasticity, contractures and muscle weakness in children with CP are disorders that can be observed more easily and are more focused and given more importance in evaluation and treatment approaches; Inadequate or loss of selective motor control negatively affects motor functions to a greater extent. It is very important to reveal the causes and consequences of selective motor disability in children with spastic cerebral palsy, in terms of creating effective treatment plans. The number of patients to participate in the study was determined as 100. The study will be carried out in Hatay Mustafa Kemal University Research and Application Hospital, Department of Pediatrics. In our study, demographic information will be filled in, and lower extremity selective control assessment scale (SCALE) for lower extremity, upper extremity selective control scale (SCUES) for upper extremity, and sensory assessment (touch, two-point discrimination and proprioceptive sensory assessment) will be performed on the patients who accepted the study.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Status
unknown

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

January 1, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 13, 2023

Last Update Submit

January 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of selective motor control function

    2 months

Secondary Outcomes (1)

  • The relationship between selective motor control and sensory functions

    3 months

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with spastic cerebral palsy

You may qualify if:

  • Giving consent to participate in the study
  • To be diagnosed with spastic type cerebral palsy;
  • Being between the ages of 4-18;
  • Being at level I-II-III according to the gross motor function classification system (GMFCS);
  • Not having undergone Botulinum Toxin injection/lower-upper extremity surgery in the last 6 months

You may not qualify if:

  • To be in level IV-V according to gross motor function classification system (GMFCS)
  • Having severe mental retardation who does not understand verbal commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 25, 2023

Study Start

January 1, 2023

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01