- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04653363
Evaluation of the Applicability and Reliability of the Three Meter Backwalk Test in Children With Cerebral Palsy (CP)
Cerebral palsy (CP) is a non-progressive disturbance in the development of movement and posture that occurs in the prenatal or postnatal period, causing activity limitations. Most children and adolescents with CP experience limitations in their walking skills. Restrictions in the walking ability of children with CP are an important issue for both parents and healthcare professionals involved in their treatment.
The evaluation of walking is of great importance in terms of determining the effectiveness of the physiotherapy program, shaping the program, planning orthopedic and surgical applications, and determining the effectiveness, especially in children with CP who have walking potential. In the literature, easy-to-use, valid and reliable observational gait analysis that can evaluate gait pathologies and clinical gait in children with CP are emphasized. These measurements are of great importance in clinical practice.The ability of backward walking gives the child a different task than normal, allowing the observation of body perception, trunk stability provided by anterior-posterior co-contractions, balance, correction and protective reactions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main purpose of CP rehabilitation is to ensure that the child gains maximum functional independence by obtaining the optimal development potential. Therefore, walking restrictions are one of the important problems in children with CP.
The most common type in the CP classification is the spastic type. The types with the best functional independence level in this group are; hemiparetic and diparetic CP. They do not have a good motor coordination due to stability problems caused by deviations in the center during walking. This situation affects balance and walking performance. As children get older, impairments in their walking ability become more pronounced. In addition to all these problems, hypertonus, increased stretching reflex, muscle weakness, coactivation in antagonist muscles, posture disorders, loss of proprioception, muscle and joint deformities are other factors that cause gait disturbances in children with CP. Therefore, the walking problems of the child with CP should be examined more clearly. At this point, it assigns a different task to the child with the evaluation of backward walking, and provides observation of body perception, trunk stability provided by anterior-posterior co-contractions, balance, correction and protective reactions. This observation ensures that the problem that will guide the treatment is precisely determined.The only test that can be applied to evaluate the ability to walk back is the three meter backward walk test. This test has been found to be valid and reliable in both the elderly population and patients with total knee arthroplasty.In the literature, there is no study about the three-meter backwalk test in children with CP. In this study, it was aimed to evaluate the backward walking skills of children with CP with the three meter backward walk test and to examine the applicability and reliability of the three meter backward walk test in children with CP.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey, 27090
- Hatice Adıgüzel
-
-
Batıkent
-
Gaziantep, Batıkent, Turkey, 27060
- Hatice Adıgüzel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 8-18 years with a diagnosis of Hemiparetic and Diparetic SP with a Gross Motor Function Classification System (GMFCS) Level ≤ 3
- Children diagnosed with CP with Communication Function Classification System (CFCS) ≤ 3
- Children with ≤ 3 according to the Modified Ashworth Scale (MASH)
- Complete range of passive range of motion in the ankle and knee joints
- Volunteering to participate in the study
Exclusion Criteria:
- Not having Botulinum toxin or surgical operation in the last 6 months
- Having contracture in the ankle and knee joints
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
study1 is the patients who will be assessed by first rater.
|
All assesments will be done by the first physiotherapist.
But only 3m backward test will be done by the first and second physiotherapist in the first day and second day.
Other Names:
|
2
study2 is the patients who will be assessed by second rater.
|
All assesments will be done by the first physiotherapist.
But only 3m backward test will be done by the first and second physiotherapist in the first day and second day.
Other Names:
|
3
Theh are healty peers control patients who will be assessed by first rater.
|
All assesments will be done by the first physiotherapist.
But only 3m backward test will be done by the first and second physiotherapist in the first day and second day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
three meter backward walk test
Time Frame: first evaulation of first day of assessment (observer1), second evaulation of first day of assessment (observer2), second evaulation of second day of assessment (observer1, second evaulation of second day of assessment (observer2)
|
Three meters of distance will be measured and marked.
When the signal is given, they will be asked to walk backwards safely and stop when they reach the marked point.
Patients will be allowed to look back if they wish.
The person conducting the test will walk with the patients for safety.
The measurements will be repeated 3 times and the average of the times will be recorded.
|
first evaulation of first day of assessment (observer1), second evaulation of first day of assessment (observer2), second evaulation of second day of assessment (observer1, second evaulation of second day of assessment (observer2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go Test
Time Frame: first day of assessment
|
TUG is a reliable test that measures walking speed, postural control, functional mobility, and balance.
For TUG measurement, the child will be seated in a height-adjustable chair.
The height of the seat will be adjusted so that the subject's knees and hips are bent up to 90 degrees while sitting with their feet.
A distance of 3 meters will be marked.
When the child is given a command, he will be asked to walk up to the marked area and return.
In the meantime, times are recorded.
In addition, the test will be repeated 3 times and the average time will be recorded.
|
first day of assessment
|
Timed Up and Down Stairs Test
Time Frame: first day of assessment
|
This test will be carried out on a ladder with 14 steps and a step height of 19.5 cm.
While the use of shoes is permitted during the test, the use of orthoses will not be allowed.
The child will start the test at a distance of 30 cm from the lowest step.
It will be asked to go up and down again safely, the time will be recorded.
In addition, the test will be repeated 3 times and the average time will be recorded.
|
first day of assessment
|
Four Square Step Test
Time Frame: first day of assessment
|
A square divided into 4 sections will be created on a flat floor.
Squares will be numbered.
The child will stand in square 1, facing square 2.
He will be asked to move to the squares 2-3-4-1-4-3-2-1 respectively.
Thus, the child will be able to move back and forth right and left.
It will be said that both feet must touch the ground.
The period will start with the contact of the foot on the number 2 square and end with the contact of the number 1 square.
The test will be applied 2 times and the good time will be taken.
|
first day of assessment
|
Functional Reach Test
Time Frame: first day of assessment
|
The child will be asked to stand sideways on a wall and keep the elbows in extension at 90 degrees of shoulder flexion without touching the wall.
The first measurement will be made at this position.
He will then be asked to stretch forward without taking any steps.
The last point it can reach will be recorded.
These two distances will be measured and recorded in meters.
The test will be repeated when stepping or the foot is cut off from the ground.
|
first day of assessment
|
Pediatric Berg Balance Scale
Time Frame: first day of assessment
|
Balance assessment of the children to be included in the study will be made with the Pediatric Berg Balance Scale.
The scale consists of 14 parts and each part is scored between 0 and 4. The highest score that can be obtained from the scale is 56.
In the PBRS, the sections in the standard BDI are listed from easy to difficult.
|
first day of assessment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: hatice adıgüzel, PhD, sanko Üniversitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SankoUniv
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on assessments
-
Institut National de la Santé Et de la Recherche...University College, LondonCompletedHuntington Disease | White Matter AlterationsFrance
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)CompletedMood Disorders | Hypertension | Sleep | Overweight and Obesity | Vascular Stiffness | Elevated Blood PressureUnited States
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHypertension | Sleep | Prehypertension | Endothelial Dysfunction | Overweight and Obesity | Vascular Stiffness | Elevated Blood PressureUnited States
-
National Heart Centre SingaporeSingapore National Eye CentreUnknownMicroalbuminuria | Diastolic Dysfunction | Retinopathy, DiabeticSingapore
-
Swiss Tropical & Public Health InstituteWorld BankActive, not recruitingCompliant Behavior | Morbidity;InfantSwitzerland, Congo, The Democratic Republic of the
-
University Health Network, TorontoRecruiting
-
Bioray LaboratoriesXiangya Hospital of Central South University; The 923rd Hospital of Joint Logistics...Recruiting
-
Hacettepe UniversityRecruiting
-
Memorial Sloan Kettering Cancer CenterIcahn School of Medicine at Mount SinaiActive, not recruitingLow Risk Prostate CancerUnited States
-
BiogenCompletedFrontotemporal Dementia | Behavioral Variant Frontotemporal DementiaUnited States