NCT05583929

Brief Summary

Trunk control in children with spastic Cerebral Palsy (CP) is impaired. They have weaker trunk muscle strenght, and insufficient sitting/standing balance according to their developing peers. Since their weak trunk muscles and insufficient balance responses, they are not able to walk as functional similar to their peers. Additionaly limit of stability is worsen in children with CP. Investigation of the relationship between walking ability and limit of stability when seated position is important to understand which child is acceptable for training of walk. However we did not found any study to explain it. Therefore the aim of this study is to investigate walking ability and limit of stability in children with spastic CP, and to compare their developing peers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 29, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

October 7, 2022

Last Update Submit

November 29, 2022

Conditions

Keywords

gait, walking ability, limit of stability, cerebral palsy

Outcome Measures

Primary Outcomes (2)

  • Gait parameters (stride length in cm, step width in cm, time in swing phase in second, time in stance phase in second)

    Gait parameters will be assessed by GAITRite walking way system.

    20 minutes

  • Limit of stability when sitting and standing position in cm

    Limit of stability will be evaluated by BERTEC balance system.

    20 minutes

Study Arms (2)

Spastic Cerebral Palsy

Children with spastic cerebral palsy

Other: GAITRite gaitway system, Bertec Balance System

Healthy Developing Peers

Children with healthy developing peers

Other: GAITRite gaitway system, Bertec Balance System

Interventions

GAITRite gaitway system will use to assess gait parameters, Bertec Balance System will use to assess limit of stability

Healthy Developing PeersSpastic Cerebral Palsy

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Spastic cerebral palsy and their developing peers

You may qualify if:

  • spastic serebral palsy, between the ages 6-15 years, between the I-IV. levels of GMFCS, be able to understand command given by physical therapist

You may not qualify if:

  • undergone botulinum toxin A to upper and/or lower extremities, undergone any surgery to their extremities, be at the V. levels of GMFCS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Altındağ, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gait Disorders, NeurologicCerebral Palsy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Bayram Sırrı, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bayram Sırrı, PT, MSc,

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phisical Therapist, Research Asistant, Master in Science

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 18, 2022

Study Start

November 29, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2024

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations