Cerebral PalsyNCT04777773
Dual-task Training in Children With Cerebral Palsy
A study testing dual-task training in people with Cerebral Palsy and Diplegia, run by Sema BÜĞÜŞAN ORUÇ at 1 site in Turkey (Türkiye).
Trial summary
There are studies investigating the dual-task effect in sitting, standing up without sitting and walking in children with spastic CP. Some of these studies investigated motor-motor, some of them motor-cognitive dual-task states, and children with CP were compared to typically developing children. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cerebral Palsy, Diplegia, Hemiplegic Cerebral Palsy
- What is being tested?
- dual-task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jun 2019to 27 Feb 2020
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being diagnosed with cerebral palsy,
- Having spastic type unilateral and bilateral involvement,
- Being between the ages of 7-18,
- Being GMFCSS Level I and Level II,
- Continuing normal education (not being a mainstreaming student),
- Not having any surgical operation involving the musculoskeletal system in the last 6 months,
- Not having Botulinum Toxin application in the last 6 months.
Who cannot join
- Failing to accomplish the cognitive task (starting from a number between 0-100 and not counting back 1 each)
- Being a behavioral problem that makes it difficult to participate in the study,
- Inability to walk without support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dual-task Training on Activity and Participation in Children With Cerebral Palsy
There are studies investigating the dual-task effect in sitting, standing up without sitting and walking in children with spastic CP. Some of these studies investigated motor-motor, some of them motor-cognitive dual-task states, and children with CP were compared to typically developing children. In all these studies, it is clearly seen that children with CP have more dual-task complexities than their typically developing peers. Some of these studies draw attention to dual-task education in children with CP. However, other than a randomized controlled study and a case report in the literature, we did not find any studies investigating the effectiveness of dual-task training in children with CP. When the literature is examined in detail, there is no study that examines the effect of dual-task exercise programs on walking activities and children's participation in daily life in children with CP.
This study has been planned based on this deficiency in the literature. Based on ICF, This study has been planned dual-task training for children with CP.
- Conditions
- Cerebral Palsy, Diplegia, Hemiplegic Cerebral Palsy, Physical Disability, Participation, Patient, Activity, Motor
- Being tested
- dual-task training
- Keywords
- cerebral palsy, dual-task training, activity, participation
- Medical subject headings
- Cerebral Palsy, Patient Participation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual-task trainingOther
dual-task training
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | classical physical therapy+ classical physical therapy Receives: Other: dual-task training |
| study group | Other | classical physical therapy+ dual-task training Receives: Other: dual-task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
10m walking test
10m walking test (the speed of gait is measured)
Measured: 5 min
10m walking test with dual-task
10m walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
Measured: 5 min
10m backward walking test
10m backward walking test (the speed of gait is measured)
Measured: 5 min
10m backward walking test with dual-task
10m backward walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
Measured: 5 min
balance
Balance skills of participators are assessed with 'Pediatric Berg Balance' .
Measured: 15 min
participation of daily life
Participation of daily life of children are assessed with PODCI questionnaire.
Measured: 15 min
Visual Gait Assessment
Participators' positions of joints are assessed with Edinburg Visual Score. Children walked 10m walking pathway. The camera records were frontside, backward, and laterals.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start27 Jun 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sema BÜĞÜŞAN ORUÇ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sema BÜĞÜŞAN ORUÇ, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777773
- Sponsor's protocol ID
- Ordu347
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual-task Training on Activity and Participation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04777773
- Acronym / sponsor ID
- Ordu347
- Conditions
- Cerebral Palsy, Diplegia, Hemiplegic Cerebral Palsy, Physical Disability, Participation, Patient, Activity, Motor
- Keywords
- cerebral palsy, dual-task training, activity, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sema BÜĞÜŞAN ORUÇUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 2 Mar 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.
There are studies investigating the dual-task effect in sitting, standing up without sitting and walking in children with spastic CP. Some of these studies investigated motor-motor, some of them motor-cognitive dual-task states, and children with CP were compared to typically developing children. In all these studies, it is clearly seen that children with CP have more dual-task complexities than their typically developing peers. Some of these studies draw attention to dual-task education in children with CP. However, other than a randomized controlled study and a case report in the literature, we did not find any studies investigating the effectiveness of dual-task training in children with CP. When the literature is examined in detail, there is no study that examines the effect of dual-task exercise programs on walking activities and children's participation in daily life in children with CP.
This study has been planned based on this deficiency in the literature. Based on ICF, This study has been planned dual-task training for children with CP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: dual-task trainingclassical physical therapy+ classical physical therapy |
| study group | Other | Other: dual-task trainingclassical physical therapy+ dual-task training |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Being diagnosed with cerebral palsy,
- Having spastic type unilateral and bilateral involvement,
- Being between the ages of 7-18,
- Being GMFCSS Level I and Level II,
- Continuing normal education (not being a mainstreaming student),
Key exclusion criteria (3 listed)
- Failing to accomplish the cognitive task (starting from a number between 0-100 and not counting back 1 each)
- Being a behavioral problem that makes it difficult to participate in the study,
- Inability to walk without support
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 |
|---|---|---|
| dual-task trainingdual-task training | Other | control group, study group |
Primary outcome
10m walking test
Time frame: 5 min
10m walking test (the speed of gait is measured)
10m walking test with dual-task
Time frame: 5 min
10m walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
10m backward walking test
Time frame: 5 min
10m backward walking test (the speed of gait is measured)
10m backward walking test with dual-task
Time frame: 5 min
10m backward walking test with dual-task (the speed of gait is measured) (dual- task is counting backwards)
balance
Time frame: 15 min
Balance skills of participators are assessed with 'Pediatric Berg Balance' .
participation of daily life
Time frame: 15 min
Participation of daily life of children are assessed with PODCI questionnaire.
Visual Gait Assessment
Time frame: 10 min
Participators' positions of joints are assessed with Edinburg Visual Score. Children walked 10m walking pathway. The camera records were frontside, backward, and laterals.
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 2 Mar 2021.
- 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?
A study testing dual-task training in people with Cerebral Palsy and Diplegia, run by Sema BÜĞÜŞAN ORUÇ 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 7 inclusion and 3 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 2 Mar 2021. 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?
10m walking test (time frame: 5 min). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2021.