- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05583929
Walking Ability and Limit of Stability in Children With Spastic Cerebral Palsy
November 29, 2022 updated by: Bayram Sırrı, Muş Alparlan University
an Investigation of the Relationship Between Walking Ability and Limit of Stability in Children With Spastic Cerebral Palsy
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ankara
-
Altındağ, Ankara, Turkey
- Recruiting
- Hacettepe University
-
Principal Investigator:
- Semra Topuz, Prof.
-
Sub-Investigator:
- Gökhan Karakaş, MSc
-
Sub-Investigator:
- Alev Doğan, MSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Spastic cerebral palsy and their developing peers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- undergone botulinum toxin A to upper and/or lower extremities, undergone any surgery to their extremities, be at the V. levels of GMFCS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Spastic Cerebral Palsy
Children with spastic cerebral palsy
|
GAITRite gaitway system will use to assess gait parameters, Bertec Balance System will use to assess limit of stability
|
Healthy Developing Peers
Children with healthy developing peers
|
GAITRite gaitway system will use to assess gait parameters, Bertec Balance System will use to assess limit of stability
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait parameters (stride length in cm, step width in cm, time in swing phase in second, time in stance phase in second)
Time Frame: 20 minutes
|
Gait parameters will be assessed by GAITRite walking way system.
|
20 minutes
|
Limit of stability when sitting and standing position in cm
Time Frame: 20 minutes
|
Limit of stability will be evaluated by BERTEC balance system.
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2022
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
October 7, 2022
First Submitted That Met QC Criteria
October 13, 2022
First Posted (Actual)
October 18, 2022
Study Record Updates
Last Update Posted (Actual)
December 2, 2022
Last Update Submitted That Met QC Criteria
November 29, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO-22/398
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gait, Spastic
-
Sanko UniversityCompletedCerebral Palsy | Gait, Hemiplegic | Gait, Spastic | Hemiplegic Cerebral Palsy | Cerebral Palsy Spastic DiplegiaTurkey
-
Chang Gung Memorial HospitalRecruitingSpastic | Spastic GaitTaiwan
-
Shifa Tameer-e-Millat UniversityRecruitingSpastic Cerebral Palsy | Spastic GaitPakistan
-
Centre d'Investigation Clinique et Technologique...CompletedFatigue | Spastic Gait | Fall Due to Failure of SupportFrance
-
Cairo UniversityCompleted
-
Henri Mondor University HospitalNot yet recruitingNeurologic Disorder | Gait, Hemiplegic | Block | Spastic Hemiplegia
-
University of IoanninaRecruiting
-
Kahramanmaras Sutcu Imam UniversityCompletedCerebral Palsy | Gait, Spastic | Gait Disorders in Children | Physical InactivityTurkey
-
MetroHealth Medical CenterRecruitingStroke | Gait, Hemiplegic | Gait, Spastic | Chronic Stroke | Walking, DifficultyUnited States
Clinical Trials on GAITRite gaitway system, Bertec Balance System
-
Mayo ClinicRecruiting
-
California State University, NorthridgeRecruitingHead Injury | Sport Injury | Concussion, BrainUnited States
-
California State University, NorthridgeRecruitingHead Injury | Sport Injury | Concussion, BrainUnited States
-
Bezmialem Vakif UniversityCompletedGait Disorders in Children | Balance | Postural Stability | Postural Control | Idiopathic Toe WalkingTurkey
-
Bezmialem Vakif UniversityCompletedGait Disorders in Children | Balance | Postural Stability | Postural Control | Femoral AnteversionTurkey
-
Cairo UniversityCompleted
-
St. Jude Children's Research HospitalTennessee Physical Therapy AssociationCompletedOsteonecrosisUnited States
-
Kirsehir Ahi Evran UniversitesiRecruiting
-
Beta-Stim Ltd.Meditrial Europe Ltd.Completed