NCT05505149

Brief Summary

To purpose of this study is ;to evaluate prognosis of functionality in children with Cerebral Palsy in different age groups (preschool, school age and adolescence) and predict the progression of motor function according to different functional classification systems in children with CP over a 2 year period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

August 16, 2022

Last Update Submit

August 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function Classification System (GMFCS)

    The GMFCS is a system that classifies the gross motor functions of the child with CP. This system includes five levels: 1 (most independent) to level 5 (fully dependent).

    two years

Secondary Outcomes (3)

  • Manual Ability Classification System (MACS)

    two years

  • Communication Function Classification System (CFCS)

    two years

  • Eating and Drinking Ability Classification System (EDACS)

    two years

Study Arms (3)

0 to 6 years old spastic cerebral palsy

ACTIVE COMPARATOR

Children were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers.

Other: physiotherapy

7 to 12 years old spastic cerebral palsy

ACTIVE COMPARATOR

Children were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers.

Other: physiotherapy

13 to 18 years old spastic cerebral palsy

ACTIVE COMPARATOR

Children were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers.

Other: physiotherapy

Interventions

Children were individually included in the physiotherapy and rehabilitation program for 2 years, with 45 minutes each session, two days a week. All children's treatment program included targeted, personalized functional exercises according to neurodevelopmental treatment principles, and they were applied by the physiotherapists of the children in the rehabilitation centers.

0 to 6 years old spastic cerebral palsy13 to 18 years old spastic cerebral palsy7 to 12 years old spastic cerebral palsy

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • being aged between 0-18 years old,
  • being diagnosed with spastic type CP.

You may not qualify if:

  • having botulinum toxin injection
  • having orthopedic surgery
  • having epileptic seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BAIBU

Bolu, 14000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Seda AYAZ TAŞ

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Preschool age group, school age group, adolescent age group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 17, 2022

Study Start

February 1, 2020

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations