Cerebral PalsyNCT04653363
Evaluation of the Applicability and Reliability of the Three Meter Backwalk Test in Children With Cerebral Palsy (CP)
An observational study of Cerebral Palsy and Cerebral Palsy Spastic Diplegia, run by Sanko University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Cerebral Palsy Spastic Diplegia, Hemiplegic Cerebral Palsy
- What is being tested?
- assessments
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 19 Nov 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: - Children aged 8-18 years with a diagnosis of Hemiparetic and Diparetic SP with a Gross Motor Function Classification System (GMFCS) Level ≤ 3
Who may be able to join
- 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
Who cannot join
- Not having Botulinum toxin or surgical operation in the last 6 months
- Having contracture in the ankle and knee joints
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hatice Adıgüzel
Gaziantep, Batıkent, 27060
Hatice Adıgüzel
Gaziantep, 27090
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy, Cerebral Palsy Spastic Diplegia, Hemiplegic Cerebral Palsy, Gait, Hemiplegic, Gait, Spastic
- Being tested
- assessments
- Keywords
- Cerebral Palsy, backward walk, reliability, gait
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentsOther
Also called three meter backward test, Time Up and Go test, Timed Up and Down Stairs Test, Four Square Step Test
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | study1 is the patients who will be assessed by first rater. Receives: Other: assessments | |
| 2 | study2 is the patients who will be assessed by second rater. Receives: Other: assessments | |
| 3 | Theh are healty peers control patients who will be assessed by first rater. Receives: Other: assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
three meter backward walk test
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.
Measured: 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 outcomes (5)
Timed Up and Go Test
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.
Measured: first day of assessment
Timed Up and Down Stairs Test
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.
Measured: first day of assessment
Four Square Step Test
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.
Measured: first day of assessment
Functional Reach Test
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.
Measured: first day of assessment
Pediatric Berg Balance Scale
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.
Measured: first day of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start15 Dec 2020
- Primary completion1 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adıgüzel, Kahramanmaras Sutcu Imam University
- Investigators
- hatice adıgüzel, PhD, Study director, sanko Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653363
- Sponsor's protocol ID
- SankoUniv
- Status last verified
- Apr 2021
- First submitted
- 26 Nov 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Celik OF, Adiguzel H, Kirmaci ZIK, Erel S, Demirguc A. Validity and reliability of the 3-meter backward walk test in children with cerebral palsy. Acta Neurol Belg. 2023 Aug;123(4):1439-1446. doi: 10.1007/s13760-023-02259-1. Epub 2023 Apr 4.
PubMed 37014515
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Applicability and Reliability of the Three Meter Backwalk Test in Children With Cerebral Palsy (CP)
- ClinicalTrials.gov ID
- NCT04653363
- Acronym / sponsor ID
- SankoUniv
- Conditions
- Cerebral Palsy, Cerebral Palsy Spastic Diplegia, Hemiplegic Cerebral Palsy, Gait, Hemiplegic, Gait, Spastic
- Keywords
- Cerebral Palsy, backward walk, reliability, gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: assessmentsstudy1 is the patients who will be assessed by first rater. |
| 2 | – | Other: assessmentsstudy2 is the patients who will be assessed by second rater. |
| 3 | – | Other: assessmentsTheh are healty peers control patients who will be assessed by first rater. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- - Children aged 8-18 years with a diagnosis of Hemiparetic and Diparetic SP with a Gross Motor Function Classification System (GMFCS) Level ≤ 3
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Not having Botulinum toxin or surgical operation in the last 6 months
- Having contracture in the ankle and knee joints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessmentsAlso: three meter backward test, Time Up and Go test, Timed Up and Down Stairs Test, Four Square Step TestAll 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 | 1, 2, 3 |
Primary outcome
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.
5 secondary outcomes
Timed Up and Go Test
Time frame: first day of assessment
Timed Up and Down Stairs Test
Time frame: first day of assessment
Four Square Step Test
Time frame: first day of assessment
Functional Reach Test
Time frame: first day of assessment
Pediatric Berg Balance Scale
Time frame: first day of assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Derived from this study: PubMed 37014515Celik OF, Adiguzel H, Kirmaci ZIK, Erel S, Demirguc A. Validity and reliability of the 3-meter backward walk test in children with cerebral palsy. Acta Neurol Belg. 2023 Aug;123(4):1439-1446. doi: 10.1007/s13760-023-02259-1. Epub 2023 Apr 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hatice adıgüzel, PhD study director
sanko Üniversitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Cerebral Palsy Spastic Diplegia, run by Sanko University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04653363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.