Cerebral PalsyNCT05088629
3-meter Walk Back Test, Proprioception, Trunk Control and Muscle Strength in Children With Cerebral Palsy
A study testing Clinical Tests in people with Cerebral Palsy, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
The gait problems of the child with CP should be examined in detail. At this point, by assigning a different task to the child with the backward walking assessment, body perception, trunk stability provided by anterior-posterior cocontraction, balance, correction and protective reactions are observed. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Clinical Tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Feb 2022
- Phase
- Interventional
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The age of onset of maturation of walking, in terms of covering the maturation ages and between 6-15 years old,
- Children with CP with a Communication Function Classification System (CFCS) ≤ 3,
- Children with upper extremity muscles ≤ 2 according to the Modified Ashworth Scale (MASH)
- Children in Level-I-II, which are groups with independent walking ability according to Gross Motor Function Classification System,
- Not having any known vision problems in terms of not affecting the postural control responses,
- Not using any pharmacological agent that may affect muscle tone,
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- Able to follow verbal commands without mental retardation at a level that interferes with communication,
- Those who have not had any Boutilinum Toxin injection and/or orthopedic surgery in the lower extremity in the last six months,
- Children without epileptic seizures will be included.
Who cannot join
- Having contractures in any joint of the hip, knee and ankle in the lower extremity,
- Children with hearing and vision problems with any diagnosis will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of the 3-meter Back Walk Test With Proprioception, Trunk Control and Muscle Strength in Children With Cerebral Palsy
The gait problems of the child with CP should be examined in detail. At this point, by assigning a different task to the child with the backward walking assessment, body perception, trunk stability provided by anterior-posterior cocontraction, balance, correction and protective reactions are observed. This observation ensures the exact determination of the problem that will guide the treatment.
Back walking is a more difficult activity as it involves neuromuscular control and depends on proprioceptive sense and protective reflexes. In activities of daily living, backward walking is needed to perform tasks such as leaning on a chair and opening the door.
The only test that can be applied to evaluate the ability to walk backwards is the 3 meter back walk test. This test was found to be valid and reliable both in the elderly population and in patients with total knee arthroplasty. In the literature, no study has been found on the factors affecting the three-meter backward walking skills in children with CP. The aim of this study is to examine the relationship between 3 meter back walk test and proprioception, trunk control and muscle strength.
Read the detailed description
Cerebral palsy is a non-progressive neurodevelopmental disorder that occurs in the immature brain during pregnancy, birth or postpartum. It is the picture of childhood that most frequently causes functional disability. Motor development retardation, balance and posture problems are among the most important problems that cause disability in CP. This picture is often accompanied by cognitive, sensory, perceptual deficiencies, orthopedic disorders and other medical problems. In children with spastic CP, selective movement deficiencies, lack of muscle strength, lack of postural control, lack of proprioception sense, loss of balance and coordination, muscle tone disorders, and motor development delays are seen. Disorders due to muscle tone problems, secondary joint deformations and alignment problems, especially in walking function, are common problems in activities performed against gravity.
Deficiencies in trunk strength and control, lack of strength in antigravity muscles, severity of spasticity, loss of balance and coordination, combined with time-distance problems of walking, cause excessive energy consumption, insufficient for daily living activities and social participation, negatively affecting quality of life, causing muscle and joint problems over time. gait pattern.
The main purpose of the study is to examine the relationship of the 3-meter back walk test with proprioception, trunk control and muscle strength in children with cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Clinical Tests
- Keywords
- cerebral palsy, back walk, proprioception, trunk control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical TestsDiagnostic test
Clinical Tests
| Study group | Role | What they receive |
|---|---|---|
| One group | Other | 3-meter Walk Back Test, Proprioception, Trunk Control and Muscle Strength test Receives: Diagnostic Test: Clinical Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 meter back walk test
A distance of three meters 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.
Measured: At baseline
Secondary outcomes (4)
Proprioception
Evaluation of proprioception with a goniometer
Measured: At baseline
Trunk Control Measurement Scale
It consists of two main parts, static sitting balance and dynamic sitting balance. An increase in the score indicates increased trunk control.
Measured: At baseline
Muscle Strength
Muscle strength will be evaluated with a digital manual muscle dynamometer.
Measured: At baseline
Gillette Functional Walking Assessment Questionnaire
It is an observational assessment scale that evaluates the functional effectiveness of walking.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start15 Nov 2021
- Primary completion15 Jan 2022
- Study completion15 Feb 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zekiye ipek katırcı kırmacı, Sanko University
- Investigators
- Nevin ERGUN, Prof., Study director, Sanko UniversityEnver KATIRCI, pt, Principal investigator, Rehabilitation CenterHatice ADIGÜZEL, asst. prof., Study director, Kahramanmaras Sutcu Imam UniversityZekiye İpek KATIRCI KIRMACI, asst. prof., Study director, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088629
- Sponsor's protocol ID
- universitysanko
- Status last verified
- Apr 2022
- First submitted
- 11 Oct 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katirci E, Adiguzel H, Katirci Kirmaci ZI, Ergun N. The relationship between the backward walking and proprioception, trunk control, and muscle strength in children with cerebral palsy. Ir J Med Sci. 2023 Oct;192(5):2391-2399. doi: 10.1007/s11845-022-03270-w. Epub 2023 Jan 6.
PubMed 36604372
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of the 3-meter Back Walk Test With Proprioception, Trunk Control and Muscle Strength in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05088629
- Acronym / sponsor ID
- universitysanko
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, back walk, proprioception, trunk control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 22 Oct 2021 (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.
The gait problems of the child with CP should be examined in detail. At this point, by assigning a different task to the child with the backward walking assessment, body perception, trunk stability provided by anterior-posterior cocontraction, balance, correction and protective reactions are observed. This observation ensures the exact determination of the problem that will guide the treatment.
Back walking is a more difficult activity as it involves neuromuscular control and depends on proprioceptive sense and protective reflexes. In activities of daily living, backward walking is needed to perform tasks such as leaning on a chair and opening the door.
The only test that can be applied to evaluate the ability to walk backwards is the 3 meter back walk test. This test was found to be valid and reliable both in the elderly population and in patients with total knee arthroplasty. In the literature, no study has been found on the factors affecting the three-meter backward walking skills in children with CP. The aim of this study is to examine the relationship between 3 meter back walk test and proprioception, trunk control and muscle strength.
Detailed description
Cerebral palsy is a non-progressive neurodevelopmental disorder that occurs in the immature brain during pregnancy, birth or postpartum. It is the picture of childhood that most frequently causes functional disability. Motor development retardation, balance and posture problems are among the most important problems that cause disability in CP. This picture is often accompanied by cognitive, sensory, perceptual deficiencies, orthopedic disorders and other medical problems. In children with spastic CP, selective movement deficiencies, lack of muscle strength, lack of postural control, lack of proprioception sense, loss of balance and coordination, muscle tone disorders, and motor development delays are seen. Disorders due to muscle tone problems, secondary joint deformations and alignment problems, especially in walking function, are common problems in activities performed against gravity.
Deficiencies in trunk strength and control, lack of strength in antigravity muscles, severity of spasticity, loss of balance and coordination, combined with time-distance problems of walking, cause excessive energy consumption, insufficient for daily living activities and social participation, negatively affecting quality of life, causing muscle and joint problems over time. gait pattern.
The main purpose of the study is to examine the relationship of the 3-meter back walk test with proprioception, trunk control and muscle strength in children with cerebral palsy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group | Other | Diagnostic Test: Clinical Tests3-meter Walk Back Test, Proprioception, Trunk Control and Muscle Strength test |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- The age of onset of maturation of walking, in terms of covering the maturation ages and between 6-15 years old,
- Children with CP with a Communication Function Classification System (CFCS) ≤ 3,
- Children with upper extremity muscles ≤ 2 according to the Modified Ashworth Scale (MASH)
- Children in Level-I-II, which are groups with independent walking ability according to Gross Motor Function Classification System,
- Not having any known vision problems in terms of not affecting the postural control responses,
Key exclusion criteria (2 listed)
- Having contractures in any joint of the hip, knee and ankle in the lower extremity,
- Children with hearing and vision problems with any diagnosis will not be included in the study.
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 |
|---|---|---|
| Clinical TestsClinical Tests | Diagnostic test | One group |
Primary outcome
3 meter back walk test
Time frame: At baseline
A distance of three meters 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.
4 secondary outcomes
Proprioception
Time frame: At baseline
Trunk Control Measurement Scale
Time frame: At baseline
Muscle Strength
Time frame: At baseline
Gillette Functional Walking Assessment Questionnaire
Time frame: At baseline
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 19 Apr 2022.
- Derived from this study: PubMed 36604372Katirci E, Adiguzel H, Katirci Kirmaci ZI, Ergun N. The relationship between the backward walking and proprioception, trunk control, and muscle strength in children with cerebral palsy. Ir J Med Sci. 2023 Oct;192(5):2391-2399. doi: 10.1007/s11845-022-03270-w. Epub 2023 Jan 6.
- 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.
Nevin ERGUN, Prof. study director
Sanko University
Enver KATIRCI, pt principal investigator
Rehabilitation Center
Hatice ADIGÜZEL, asst. prof. study director
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Tests in people with Cerebral Palsy, run by Sanko University at 1 site 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 9 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
3 meter back walk test (time frame: At baseline). 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 NCT05088629, 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 19 Apr 2022.