Cerebral PalsyNCT06170814
Effects of Different Focuses of Attention on Walking and Balance in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Gait, Hemiplegic, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effects of different focuses (external and internal focus)of attention on functional walking and balance in children with cerebral palsy. Individuals with CP between the ages of 6-18 will be included in the research. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Gait, Hemiplegic, Balance
- What is being tested?
- Exercise
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2023to 15 Sep 2024
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with hemiparatic cerebral palsy between the ages of 6 and 18 will be included in the study. In order to perceive the commands during the exercise, the children participating in the study must have a level of cognitive development to be cooperative.
Who may be able to join
- Being diagnosed with spastic type cerebral palsy between the ages of 6-18
- Volunteerism of the family and individuals to participate in the study
- Being at levels I and II according to the Gross Motor Classification System
- Having the cognitive development to be cooperative
Who cannot join
- Having undergone any orthopedic and/or neurological surgery in the last 6 months,
- Having hearing and/or vision loss that would prevent participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Different Focuses of Attention on Functional Walking and Balance in Children With Cerebral Palsy
This study was planned to examine the effects of different focuses (external and internal focus)of attention on functional walking and balance in children with cerebral palsy. Individuals with CP between the ages of 6-18 will be included in the research. It was planned to include 24 individuals in total, 12 individuals in each group.
Read the detailed description
In the external focus of attention (EF), attention is directed to movement and an environmental stimulus. In the internal focus (IF), attention is directed directly to body movements. In revealing positive effects in external focus; Methods such as metaphor, analogy, imaginary objects, mental analogies can be used. Adopting an External focus of attention (focusing on the effects of movements on the object or environment), as opposed to an Internal focus of attention (focusing on body movements), has been found to significantly improve performance on a variety of tasks. Walking and balance are essential for activities of daily living and social participation; Therefore, it is often considered one of the most important activities in daily life. Walking and balance is an automatic rhythmic motor behavior controlled mostly by subcortical brain regions. Automaticity means that walking can be performed without requiring attention. Although it seems like a very simple activity, it is actually a very complex chain of movements in which the brain, spinal cord, muscles, bones and joints work together in coordination. However, movement, balance and gait disorders cause individuals with CP to spend more energy, deteriorate their mobility and decrease their independence. Although the beneficial effects of EF have not yet been demonstrated for every population, the constrained action hypothesis encourages the use of an EF for teaching motor skills. Looking at the literature, the effects of EF on the development of motor performance in children with cerebral palsy have not been examined. Therefore, this study aims to examine the effects of external focus of attention on gait and balance.
Individuals with CP between the ages of 6-18 will be included in the research. After the purpose and scope of the study are explained to all individuals and their families who agree to participate in the study, their families will be asked to read and sign the volunteering form. All individuals who meet the inclusion criteria will be randomly divided into 2 groups (external focus and internal focus). It was planned to include 24 individuals in total, 12 individuals in each group. The same evaluations will be made to all individuals participating in the study by a physiotherapist who is an expert in the field. In addition to conventional physiotherapy for 6 weeks, individuals will be included in an exercise program that focuses on external and internal attention for 30 minutes a day, 3 days a week. Evaluation of walking function will be done with the C-Mill Walking Training System. Balance function will be performed by standing on one leg, pediatric berg balance scale and functional reaching tests.Independence Pediatric Functional Independence Scale will be evaluated with.Trunk control, trunk control measurement scale will be evaluated with.
- Conditions
- Cerebral Palsy, Gait, Hemiplegic, Balance
- Being tested
- Exercise
- Keywords
- cerebral palsy, External focus, internal focus, gait and balance
- 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.
ExerciseOther
Exercise will be done for approximately 40 minutes, 3 days a week for 6 weeks. Ramps, obstacle jumping, stairs and tracks will be built to improve walking and balance functions. One group will be given external focus stimuli, the other group will be given internal focus stimuli.
| Study group | Role | What they receive |
|---|---|---|
| external odak | Exercise will be done for approximately 40 minutes, 3 days a week for 6 weeks. Ramps, obstacle jumping, stairs and tracks will be built to improve walking and balance functions. During exercises, attention is directed to movement and an environmental stimulus in the external focus of attention. Receives: Other: Exercise | |
| internal focus | Exercise will be done for approximately 40 minutes, 3 days a week for 6 weeks. Ramps, obstacle jumping, stairs, and tracks will be built to improve walking and balance functions. In internal focus during exercises, attention is directed directly to body movements. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait
Walking function will be evaluated twice with the C-Mill Walking Training System, before and at the end of treatment (6 weeks of treatment).
Measured: 6 week
Secondary outcomes (4)
balance
Balance function will be evaluated twice, before and at the end of treatment (6 weeks of treatment), with the one-leg standing test and the functional reaching test.
Measured: 6 week
Trunk control measurement scale
trunk control, trunk control measurement scale will be evaluated with.
Measured: 6 week
Pediatric Functional Independence Scale
Independence, Pediatric Functional Independence Scale will be evaluated with.
Measured: 6 week
pediatric berg balance scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start30 Dec 2023
- Primary completion15 Aug 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170814
- Sponsor's protocol ID
- Cerebral palsy and gait
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2023
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beauchet O, Berrut G. [Gait and dual-task: definition, interest, and perspectives in the elderly]. Psychol Neuropsychiatr Vieil. 2006 Sep;4(3):215-25. French.
PubMed 16945851Yamada M, Raisbeck LD, Porter JM. The Effects of Using Imagery to Elicit an External Focus of Attention. Res Q Exerc Sport. 2021 Sep;92(3):559-565. doi: 10.1080/02701367.2020.1733455. Epub 2020 Mar 6.
PubMed 32142388Bunger A, Urfer-Maurer N, Grob A. Multimethod Assessment of Attention, Executive Functions, and Motor Skills in Children With and Without ADHD: Children's Performance and Parents' Perceptions. J Atten Disord. 2021 Feb;25(4):596-606. doi: 10.1177/1087054718824985. Epub 2019 Jan 30.
PubMed 30700232Blank R, Barnett AL, Cairney J, Green D, Kirby A, Polatajko H, Rosenblum S, Smits-Engelsman B, Sugden D, Wilson P, Vincon S. International clinical practice recommendations on the definition, diagnosis, assessment, intervention, and psychosocial aspects of developmental coordination disorder. Dev Med Child Neurol. 2019 Mar;61(3):242-285. doi: 10.1111/dmcn.14132. Epub 2019 Jan 22.
PubMed 30671947Zorlular R, Akinci M, Elbasan B. Effects of focus of attention on gait parameters and balance performance in children with unilateral cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2026 Feb;48(3):829-841. doi: 10.1080/09638288.2025.2548412. Epub 2025 Aug 21.
PubMed 40839080
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Different Focuses of Attention on Functional Walking and Balance in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06170814
- Acronym / sponsor ID
- Cerebral palsy and gait
- Conditions
- Cerebral Palsy, Gait, Hemiplegic, Balance
- Keywords
- cerebral palsy, External focus, internal focus, gait and balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 14 Dec 2023 (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.
This study was planned to examine the effects of different focuses (external and internal focus)of attention on functional walking and balance in children with cerebral palsy. Individuals with CP between the ages of 6-18 will be included in the research. It was planned to include 24 individuals in total, 12 individuals in each group.
Detailed description
In the external focus of attention (EF), attention is directed to movement and an environmental stimulus. In the internal focus (IF), attention is directed directly to body movements. In revealing positive effects in external focus; Methods such as metaphor, analogy, imaginary objects, mental analogies can be used. Adopting an External focus of attention (focusing on the effects of movements on the object or environment), as opposed to an Internal focus of attention (focusing on body movements), has been found to significantly improve performance on a variety of tasks. Walking and balance are essential for activities of daily living and social participation; Therefore, it is often considered one of the most important activities in daily life. Walking and balance is an automatic rhythmic motor behavior controlled mostly by subcortical brain regions. Automaticity means that walking can be performed without requiring attention. Although it seems like a very simple activity, it is actually a very complex chain of movements in which the brain, spinal cord, muscles, bones and joints work together in coordination. However, movement, balance and gait disorders cause individuals with CP to spend more energy, deteriorate their mobility and decrease their independence. Although the beneficial effects of EF have not yet been demonstrated for every population, the constrained action hypothesis encourages the use of an EF for teaching motor skills. Looking at the literature, the effects of EF on the development of motor performance in children with cerebral palsy have not been examined. Therefore, this study aims to examine the effects of external focus of attention on gait and balance.
Individuals with CP between the ages of 6-18 will be included in the research. After the purpose and scope of the study are explained to all individuals and their families who agree to participate in the study, their families will be asked to read and sign the volunteering form. All individuals who meet the inclusion criteria will be randomly divided into 2 groups (external focus and internal focus). It was planned to include 24 individuals in total, 12 individuals in each group. The same evaluations will be made to all individuals participating in the study by a physiotherapist who is an expert in the field. In addition to conventional physiotherapy for 6 weeks, individuals will be included in an exercise program that focuses on external and internal attention for 30 minutes a day, 3 days a week. Evaluation of walking function will be done with the C-Mill Walking Training System. Balance function will be performed by standing on one leg, pediatric berg balance scale and functional reaching tests.Independence Pediatric Functional Independence Scale will be evaluated with.Trunk control, trunk control measurement scale will be evaluated with.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| external odak | – | Other: ExerciseExercise will be done for approximately 40 minutes, 3 days a week for 6 weeks. Ramps, obstacle jumping, stairs and tracks will be built to improve walking and balance functions. During exercises, attention is directed to movement and an environmental stimulus in the external focus of attention. |
| internal focus | – | Other: ExerciseExercise will be done for approximately 40 minutes, 3 days a week for 6 weeks. Ramps, obstacle jumping, stairs, and tracks will be built to improve walking and balance functions. In internal focus during exercises, attention is directed directly to body movements. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with hemiparatic cerebral palsy between the ages of 6 and 18 will be included in the study. In order to perceive the commands during the exercise, the children participating in the study must have a level of cognitive development to be cooperative.
Key inclusion criteria (4 listed)
- Being diagnosed with spastic type cerebral palsy between the ages of 6-18
- Volunteerism of the family and individuals to participate in the study
- Being at levels I and II according to the Gross Motor Classification System
- Having the cognitive development to be cooperative
Key exclusion criteria (2 listed)
- Having undergone any orthopedic and/or neurological surgery in the last 6 months,
- Having hearing and/or vision loss that would prevent participation 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 |
|---|---|---|
| ExerciseExercise will be done for approximately 40 minutes, 3 days a week for 6 weeks. Ramps, obstacle jumping, stairs and tracks will be built to improve walking and balance functions. One group will be given external focus stimuli, the other group will be given internal focus stimuli. | Other | external odak, internal focus |
Primary outcome
Gait
Time frame: 6 week
Walking function will be evaluated twice with the C-Mill Walking Training System, before and at the end of treatment (6 weeks of treatment).
4 secondary outcomes
balance
Time frame: 6 week
Trunk control measurement scale
Time frame: 6 week
Pediatric Functional Independence Scale
Time frame: 6 week
pediatric berg balance scale
Time frame: 6 week
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 31 Dec 2024.
- Results publication: PubMed 16945851Beauchet O, Berrut G. [Gait and dual-task: definition, interest, and perspectives in the elderly]. Psychol Neuropsychiatr Vieil. 2006 Sep;4(3):215-25. French.
- Results publication: PubMed 32142388Yamada M, Raisbeck LD, Porter JM. The Effects of Using Imagery to Elicit an External Focus of Attention. Res Q Exerc Sport. 2021 Sep;92(3):559-565. doi: 10.1080/02701367.2020.1733455. Epub 2020 Mar 6.
- Results publication: PubMed 30700232Bunger A, Urfer-Maurer N, Grob A. Multimethod Assessment of Attention, Executive Functions, and Motor Skills in Children With and Without ADHD: Children's Performance and Parents' Perceptions. J Atten Disord. 2021 Feb;25(4):596-606. doi: 10.1177/1087054718824985. Epub 2019 Jan 30.
- Results publication: PubMed 30671947Blank R, Barnett AL, Cairney J, Green D, Kirby A, Polatajko H, Rosenblum S, Smits-Engelsman B, Sugden D, Wilson P, Vincon S. International clinical practice recommendations on the definition, diagnosis, assessment, intervention, and psychosocial aspects of developmental coordination disorder. Dev Med Child Neurol. 2019 Mar;61(3):242-285. doi: 10.1111/dmcn.14132. Epub 2019 Jan 22.
- Derived from this study: PubMed 40839080Zorlular R, Akinci M, Elbasan B. Effects of focus of attention on gait parameters and balance performance in children with unilateral cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2026 Feb;48(3):829-841. doi: 10.1080/09638288.2025.2548412. Epub 2025 Aug 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Gait, Hemiplegic, run by Gazi 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 4 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 31 Dec 2024. 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?
Gait (time frame: 6 week). 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 NCT06170814, which also lists 5 linked publications.
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 31 Dec 2024.