Cerebral PalsyNCT04850690
Cognitive and Motor Tasks in Cerebral Palsy
An observational study of Cerebral Palsy and Gait Disorders, Neurologic, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Various gait deviations are observed in children with cerebral palsy. Our aim was to determine the effect of cognitive task (CT) and motor task (MT) on gait in children with cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Gait Disorders, Neurologic, Cognitive Orientation
- What is being tested?
- 2D Gait analysis
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Jul 2019
- 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 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 15 children with Cerebral Palsy, between 9-15 years old
Who may be able to join
- having been diagnosed with CP in the health committee
- being between 9-15 years of age, having a mental level as "normal" (in terms of compliance with the exercises)
- being in Gross Motor Function Classification System (GMFSC) Level I-II
- being in Manual Ability Classification System (MACS) Level I-II
- being in Communication Function Classification System (CFSS) Level I (communication method is speech).
Who cannot join
- having a mental retardation
- having severe vision impairment
- underwenting Botulinum Toxin (BOTOX) injection or surgery affecting lower extremities in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34815
About this study
Official title: Effect of Cognitive and Motor Tasks on Gait in Individuals With Cerebral Palsy
Various gait deviations are observed in children with cerebral palsy. Our aim was to determine the effect of cognitive task (CT) and motor task (MT) on gait in children with cerebral palsy (CP). 15 children with CP, between 9-15 years old, with Communication Function Classification System (CFSS) level I, with Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) level I-II were included in the study. The gait with four different conditions (single gait, CT, MT and CT\&MT) was evaluated by Kinovea video analysis method on a 10-meter course.
Results:
Read the detailed description
All children with CP were instructed to walk on the track under four different conditions:
- Single: Walking without task at a self-selected speed
- Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes
- Motor Task (MT): Walking while carrying an empty box
- CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in threes
The task was explained to individuals by a physiotherapist. The individuals were not allowed to use orthosis during walking performance. Running was not accepted. 30 seconds were given to take a break between tasks. The physiotherapist followed the individuals along the track in case of any falling. If the child was not able to complete the track (falling or need to rest), the evaluation was accepted uncomplete and was excluded from the database.
The Kinovea-08.15 software program was used to assess all of the outputs (images and videos) from the camera
- Being tested
- 2D Gait analysis
- Keywords
- Cerebral Palsy, Cognitive Task, Dual Task Paradigm, Motor Task, Gait
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic, Orientation, Spatial, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D Gait analysisDiagnostic test
The gait with four different conditions (single gait, Cognitive Task, Motor Task and Cognitive Task\&Motor Task) was evaluated by Kinovea video analysis method on a 10-meter course.
- Single: Walking without task at a self-selected speed
- Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes
- Motor Task (MT): Walking while carrying an empty box
- CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in threes
| Study group | Role | What they receive |
|---|---|---|
| Children with hemiparetic Cerebral palsy | 15 children with CP, between 9-15 years old Receives: Diagnostic Test: 2D Gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
2D Gait analysis
Kinovea video analysis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Nov 2018
- Primary completion1 May 2019
- Study completion1 Jul 2019
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mbudak, Istanbul Medipol University Hospital
- Investigators
- Miray BUDAK, PhD, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850690
- Sponsor's protocol ID
- CogMo-CP2021
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive and Motor Tasks on Gait in Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04850690
- Acronym / sponsor ID
- CogMo-CP2021
- Keywords
- Cerebral Palsy, Cognitive Task, Dual Task Paradigm, Motor Task, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 20 Apr 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.
Various gait deviations are observed in children with cerebral palsy. Our aim was to determine the effect of cognitive task (CT) and motor task (MT) on gait in children with cerebral palsy (CP). 15 children with CP, between 9-15 years old, with Communication Function Classification System (CFSS) level I, with Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) level I-II were included in the study. The gait with four different conditions (single gait, CT, MT and CT\&MT) was evaluated by Kinovea video analysis method on a 10-meter course.
Results:
Detailed description
All children with CP were instructed to walk on the track under four different conditions:
- Single: Walking without task at a self-selected speed
- Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes
- Motor Task (MT): Walking while carrying an empty box
- CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in threes
The task was explained to individuals by a physiotherapist. The individuals were not allowed to use orthosis during walking performance. Running was not accepted. 30 seconds were given to take a break between tasks. The physiotherapist followed the individuals along the track in case of any falling. If the child was not able to complete the track (falling or need to rest), the evaluation was accepted uncomplete and was excluded from the database.
The Kinovea-08.15 software program was used to assess all of the outputs (images and videos) from the camera
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with hemiparetic Cerebral palsy | – | Diagnostic Test: 2D Gait analysis15 children with CP, between 9-15 years old |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 15 children with Cerebral Palsy, between 9-15 years old
Key inclusion criteria (5 listed)
- having been diagnosed with CP in the health committee
- being between 9-15 years of age, having a mental level as "normal" (in terms of compliance with the exercises)
- being in Gross Motor Function Classification System (GMFSC) Level I-II
- being in Manual Ability Classification System (MACS) Level I-II
- being in Communication Function Classification System (CFSS) Level I (communication method is speech).
Key exclusion criteria (3 listed)
- having a mental retardation
- having severe vision impairment
- underwenting Botulinum Toxin (BOTOX) injection or surgery affecting lower extremities in the last 6 months.
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 |
|---|---|---|
| 2D Gait analysisThe gait with four different conditions (single gait, Cognitive Task, Motor Task and Cognitive Task\&Motor Task) was evaluated by Kinovea video analysis method on a 10-meter course. * Single: Walking without task at a self-selected speed * Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes * Motor Task (MT): Walking while carrying an empty box * CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in threes | Diagnostic test | Children with hemiparetic Cerebral palsy |
Primary outcome
2D Gait analysis
Time frame: through study completion, an average of 1 year
Kinovea video analysis
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 20 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Miray BUDAK, PhD study director
Medipol University
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 Disorders, Neurologic, run by Istanbul Medipol University Hospital 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 5 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 20 Apr 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?
2D Gait analysis (time frame: through study completion, an average of 1 year). 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 20 Apr 2021.