Cerebral PalsyNCT04263701
Dual Task Training in Spastic Cerebral Palsy
A study testing Therapeutic exercises and Dual Task Training in people with Cerebral Palsy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Therapeutic exercises and Dual Task Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 15 Mar 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having been diagnosed with spastic diplegic cerebral palsy,
- Being at level 1 or 2 according to the Gross Motor Function Classification System,
- Being at level 1 according to Communication Function Classification System,
- To adapt to the evaluations,
- To get 27 points or above from the Modified Mini Mental Test (MMMT).
Who cannot join
- Having had injuries such as strains, sprains or fractures of the lower extremity in the last six months,
- Having undergone a surgical intervention or Botulinum toxin in the last six months,
- Having any known chronic systemic problems,
- Having uncontrollable seizures,
- Having vision or hearing problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dual Task Training on Gait Parameters in Spastic Diplegic Cerebral Palsy
This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. The clinical study's hypothesis is the dual task training programs are superior to conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral palsy.
Read the detailed description
In this self-controlled study, children with spastic diplegic cerebral palsy, aged 7-16, who were at level 1 or 2 according to the Gross Motor Function Classification System, scored 27 and above from the Modified Mini Mental Test were included.
Children are recruited to the routine physiotherapy program 45 minutes 2 days a week for 8 weeks, and in addition to the routine physiotherapy program dual task training program 45 minutes 2 days a week for the next 8 weeks. The children will evaluate at baseline, after the routine physiotherapy program and after the dual task training program. Children will be evaluate with Gross Motor Function Measurement-88,Modified Ashworth Scale , gait platform, Edinburgh Visual Gait Score, Pediatric Berg Balance Scale,1 Minute Walk Test, Functional Independence Measure, Pediatric Quality of Life Inventory TM-Cerebral Palsy Module.
- Conditions
- Cerebral Palsy
- Being tested
- Therapeutic exercises, Dual Task Training
- Keywords
- cerebral palsy, dual task training, gait, balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercisesOther
Conventional physiotherapy exercises for children with cerebral palsy
Dual Task TrainingOther
Dual task training in addition to conventional physiotherapy exercises for children with cerebral palsy
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy Group | Active comparator | 45 minutes, 2 days in a week for 8 weeks Receives: Other: Therapeutic exercises |
| Dual Task Training Group | Experimental | 45 minutes, 2 days in a week for 8 weeks Receives: Other: Dual Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gate speed of time-distance gait parameters
Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.
Measured: Change from baseline time-distance gait parameters at 8th week and 16th week
Step length of time-distance gait parameters
Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity.
Measured: Change from baseline time-distance gait parameters at 8th week and 16th week
Stride length of time-distance gait parameters
Stride length will be evaluated using with gait platform.The software gives the outcome as cm.
Measured: Change from baseline time-distance gait parameters at 8th week and 16th week
Step time of time-distance gait parameters
Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.
Measured: Change from baseline time-distance gait parameters at 8th week and 16th week
Stride time of time-distance gait parameters
Step time will be evaluated using with gait platform.The software gives the outcome as sec.
Measured: Change from baseline time-distance gait parameters at 8th week and 16th week
Cadance of time-distance gait parameters
Step time will be evaluated using with gait platform.The software gives the outcome as steps/min.
Measured: Change from baseline time-distance gait parameters at 8th week and 16th week
Visual gait analysis
Visual gait analysis will be performed with Edinburgh Visual Gait Score. Edinburg Visual Gait Score is scoring between 0 to 34 for each lower extremity. The higher scores points above 0 means abnormal gate.
Measured: Change from baseline visual gait analysis at 8th week and 16th week
Center of Pressure path length of balance parameters
Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm.
Measured: Change from baseline balance parameters at 8th week and 16th week.
Ellipse area of balance parameters
Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.
Measured: Change from baseline balance parameters at 8th week and 16th week.
Functional balance
Functional balance will be evaluate using with Pediatric Berg Balance Scale. The scale is scoring 0-56. The higher scores indicate better functional balance.
Measured: Change from baseline functional balance at 8th week and 16th week
Secondary outcomes (5)
Gross Motor Function Measurement
Gross motor function measurement will be evaluate using with Gross Motor Function Measurement-88. The instrument consist of 5 dimensions which names are A- Lying and rolling, B- Sitting, C- Crawling and Kneeling, D- Standing and E- Walking-running-jumping. Each dimension is scoring 0-100. The higher scores indicate better motor function.
Measured: Change from baseline Gross Motor Function Measurement at 8th week and 16th week
Muscle Tonus
Muscle tonus will be evaluate using with Modified Ashworth Scale. This assesment will be performed by a physiotherapist. The Physiotherapist evaluate the muscle tonus of upper and lower extremity muscules. Scoring is between 0-4 and higher scores indicate hypertonus.
Measured: Change from baseline Muscle Tonus at 8th week and 16th week
Functional Mobility Skills
Functional mobility skills will be evaluate using with 1-Minute Walk Test. The test perform on a 20 meters platform. The patient walk on the platform as quick as in 1 munite. The walking distance is recorded.
Measured: Change from baseline Functional Mobility Skills at 8th week and 16th week
Functional Independence Levels
Functional independence levels will be evaluate using with Functional Independence Measurement (WeeFIM). WeeFIM is consist of 6 part, 18 items. It consists of self-care, sphincter control, locomotion, transfers, communication and social cognition subtitles. Scoring is between 18 to 126 and the higher scores indicate better functional indepence levels.
Measured: Change from baseline Functional Independence Levels at 8th week and 16th week
Health-related quality of life
Health-related quality of life will be evaluate using with Pediatric Quality of Life Inventory TM. The inventory include daily activities, school activities, movement and balance, pain and hurt, fatique, eating activities and speech and communication subtitles. Each subtitles is scoring 0 to 100 and the higher scores indicate lower problems.
Measured: Change from baseline health-related quality of life at 8th week and 16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jul 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Self-controlled study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Ozge OKUR, Kutahya Health Sciences University
- Investigators
- Eda Ozge Okur, Msc, Principal investigator, KMSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263701
- Sponsor's protocol ID
- KMSU
- Status last verified
- Mar 2021
- First submitted
- 4 Feb 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. The clinical study's hypothesis is the dual task training programs are superior to conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral palsy.
Publications
Okur EO, Arik MI, Okur I, Gokpinar HH, Gunel MK. Dual-task training effect on gait parameters in children with spastic diplegic cerebral palsy: Preliminary results of a self-controlled study. Gait Posture. 2022 May;94:45-50. doi: 10.1016/j.gaitpost.2022.02.020. Epub 2022 Feb 17.
PubMed 35247824
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual Task Training on Gait Parameters in Spastic Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04263701
- Acronym / sponsor ID
- KMSU
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, dual task training, gait, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 11 Feb 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.
This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. The clinical study's hypothesis is the dual task training programs are superior to conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral palsy.
Detailed description
In this self-controlled study, children with spastic diplegic cerebral palsy, aged 7-16, who were at level 1 or 2 according to the Gross Motor Function Classification System, scored 27 and above from the Modified Mini Mental Test were included.
Children are recruited to the routine physiotherapy program 45 minutes 2 days a week for 8 weeks, and in addition to the routine physiotherapy program dual task training program 45 minutes 2 days a week for the next 8 weeks. The children will evaluate at baseline, after the routine physiotherapy program and after the dual task training program. Children will be evaluate with Gross Motor Function Measurement-88,Modified Ashworth Scale , gait platform, Edinburgh Visual Gait Score, Pediatric Berg Balance Scale,1 Minute Walk Test, Functional Independence Measure, Pediatric Quality of Life Inventory TM-Cerebral Palsy Module.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Self-controlled study
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy Group | Active comparator | Other: Therapeutic exercises45 minutes, 2 days in a week for 8 weeks |
| Dual Task Training Group | Experimental | Other: Dual Task Training45 minutes, 2 days in a week for 8 weeks |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Having been diagnosed with spastic diplegic cerebral palsy,
- Being at level 1 or 2 according to the Gross Motor Function Classification System,
- Being at level 1 according to Communication Function Classification System,
- To adapt to the evaluations,
- To get 27 points or above from the Modified Mini Mental Test (MMMT).
Key exclusion criteria (5 listed)
- Having had injuries such as strains, sprains or fractures of the lower extremity in the last six months,
- Having undergone a surgical intervention or Botulinum toxin in the last six months,
- Having any known chronic systemic problems,
- Having uncontrollable seizures,
- Having vision or hearing problems.
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 |
|---|---|---|
| Therapeutic exercisesConventional physiotherapy exercises for children with cerebral palsy | Other | Conventional Physiotherapy Group |
| Dual Task TrainingDual task training in addition to conventional physiotherapy exercises for children with cerebral palsy | Other | Dual Task Training Group |
Primary outcome
Gate speed of time-distance gait parameters
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.
Step length of time-distance gait parameters
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity.
Stride length of time-distance gait parameters
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Stride length will be evaluated using with gait platform.The software gives the outcome as cm.
Step time of time-distance gait parameters
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.
Stride time of time-distance gait parameters
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Step time will be evaluated using with gait platform.The software gives the outcome as sec.
Cadance of time-distance gait parameters
Time frame: Change from baseline time-distance gait parameters at 8th week and 16th week
Step time will be evaluated using with gait platform.The software gives the outcome as steps/min.
Visual gait analysis
Time frame: Change from baseline visual gait analysis at 8th week and 16th week
Visual gait analysis will be performed with Edinburgh Visual Gait Score. Edinburg Visual Gait Score is scoring between 0 to 34 for each lower extremity. The higher scores points above 0 means abnormal gate.
Center of Pressure path length of balance parameters
Time frame: Change from baseline balance parameters at 8th week and 16th week.
Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm.
Ellipse area of balance parameters
Time frame: Change from baseline balance parameters at 8th week and 16th week.
Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.
Functional balance
Time frame: Change from baseline functional balance at 8th week and 16th week
Functional balance will be evaluate using with Pediatric Berg Balance Scale. The scale is scoring 0-56. The higher scores indicate better functional balance.
5 secondary outcomes
Gross Motor Function Measurement
Time frame: Change from baseline Gross Motor Function Measurement at 8th week and 16th week
Muscle Tonus
Time frame: Change from baseline Muscle Tonus at 8th week and 16th week
Functional Mobility Skills
Time frame: Change from baseline Functional Mobility Skills at 8th week and 16th week
Functional Independence Levels
Time frame: Change from baseline Functional Independence Levels at 8th week and 16th week
Health-related quality of life
Time frame: Change from baseline health-related quality of life at 8th week and 16th 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 23 Mar 2021.
- Derived from this study: PubMed 35247824Okur EO, Arik MI, Okur I, Gokpinar HH, Gunel MK. Dual-task training effect on gait parameters in children with spastic diplegic cerebral palsy: Preliminary results of a self-controlled study. Gait Posture. 2022 May;94:45-50. doi: 10.1016/j.gaitpost.2022.02.020. Epub 2022 Feb 17.
- Individual participant dataSharing planned: No. This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. The clinical study's hypothesis is the dual task training programs are superior to conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral palsy.
Related trials for Cerebral Palsy
Recruiting
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
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.
Eda Ozge Okur, Msc principal investigator
KMSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercises and Dual Task Training in people with Cerebral Palsy, run by Kutahya Health Sciences 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 5 inclusion and 5 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 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?
Gate speed of time-distance gait parameters (time frame: Change from baseline time-distance gait parameters at 8th week and 16th week). The study lists 10 primary outcomes in all. 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 NCT04263701, 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 Mar 2021.