Cerebral PalsyNCT05999617
Effectiveness of Dual Task Exercise Training in Children With Cerebral Palsy
A study testing Rehabilitation in people with Cerebral Palsy, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is the most common neurological disorder in children and one of the major causes of motor disability. CP causes changes in postural and sensory integration, balance, coordination disorders and muscle weakness due to problems in muscle tone. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2023to 31 Aug 2023
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hemiplegic, monoplegic, unilaterally affected or diplegic children aged 5-12 years with cerebral palsy
- Gross Motor Function Classification (GMFCS) level 1 (walks without restrictions) or 2 (walks with restrictions)
- Understand simple commands
- Signing the consent form
Who cannot join
- Children and their families who do not want to be involved in the study
- Children with vision and hearing problems
- hildren with secondary orthopedic problems and children with walking aids
- Circumstances that would prevent carrying out assessments and exercise training or communicating
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fethiye Special Son Atilim Special Education and Rehabilitation Center
Muğla, Fethiye
About this study
Official title: The Effectiveness of Dual Task Exercise Training on Balance, Mobility, Physical Performance and Quality of Life in Children With Cerebral Palsy
Cerebral palsy (CP) is the most common neurological disorder in children and one of the major causes of motor disability. CP causes changes in postural and sensory integration, balance, coordination disorders and muscle weakness due to problems in muscle tone. An effective rehabilitation program is of great importance in solving many problems that can be associated with decreased balance control. Researchers have stated that rehabilitation programs with repetitive special tasks are effective. The aim of the study was to compare the effects of conventional physiotherapy and dual task exercise training in addition to conventional physiotherapy on balance, mobility, physical performance and quality of life in children with cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Conventional rehabilitation (stretching, strengthening, balance) and dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Conventional rehabilitation (stretching, strengthening, balance) plus dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions. Receives: Other: Rehabilitation |
| Control Group | Active comparator | Conventional rehabilitation program (stretching, strengthening, balance) will be employed. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale (PBS)
The scale consists of 14 items measuring parameters such as sitting balance and standing balance. Each item is ranked from 0 to 4. 0 indicates that the instruction cannot be fulfilled, while 4 indicates that it can be fulfilled without any difficulty. The maximum total score is 56.
Measured: Change from Baseline PBS at 12 weeks
Timed Up and Go Test (TUG)
Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
Measured: Change from Baseline TUG at 12 weeks
One Leg Standing Test (OLST)
Children are tested standing on one leg using their right and left leg respectively. The test is repeated on a hard surface with eyes open and closed. The child is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The child is asked to stand with one leg while keeping the other leg in a 90 degree flexion position. A stopwatch is used to record the time the child can hold the test position. The examiner ends the test if the child can hold the position for more than 30 seconds and records the elapsed time.
Measured: Change from Baseline OLST at 12 weeks
3-Meter Backward Walk Test (3MBWT)
A distance of 3 m was measured and marked with black tape. Children were asked to follow the black tape with their heels. They were asked to walk backwards quickly with the command 'start'. When the 3 m distance was completed, they were asked to stop. The assessor walked behind the individuals throughout the test.
Measured: Change from Baseline 3MBWT at 12 weeks
6 Meter Walk Test (6MWT)
A 6-meter track is determined. Children are asked to walk at a comfortable pace with the command "Start". The stopwatch is stopped by touching the finish line.
Measured: Change from Baseline 6MWT at 12 weeks
The Generic Children's Health-Related Quality of Life Questionnaire (KINDL)
The KINDL is a self-report questionnaire available for 3 different age groups: Kiddy-KINDL for children aged 4-7 years, Kid-KINDL for children aged 8-12 years and Kiddo-KINDL for adolescents aged 13-16 years. The total score ranges from 0-100. A higher score represents a better situation.
Measured: Change from Baseline KINDL at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start12 May 2023
- Primary completion21 Aug 2023
- Study completion31 Aug 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- İsmail Uysal, PhD, Study director, Muğla Sıtkı Koçman UniversityFatih Özden, PhD, Principal investigator, Muğla Sıtkı Koçman Universityİsmet Tümtürk, MSc, Principal investigator, Süleyman Demirel UniversityAhmet İmerci, MD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999617
- Sponsor's protocol ID
- CPdualtask
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dual Task Exercise Training on Balance, Mobility, Physical Performance and Quality of Life in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05999617
- Acronym / sponsor ID
- CPdualtask
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 21 Aug 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.
Cerebral palsy (CP) is the most common neurological disorder in children and one of the major causes of motor disability. CP causes changes in postural and sensory integration, balance, coordination disorders and muscle weakness due to problems in muscle tone. An effective rehabilitation program is of great importance in solving many problems that can be associated with decreased balance control. Researchers have stated that rehabilitation programs with repetitive special tasks are effective. The aim of the study was to compare the effects of conventional physiotherapy and dual task exercise training in addition to conventional physiotherapy on balance, mobility, physical performance and quality of life in children with cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: RehabilitationConventional rehabilitation (stretching, strengthening, balance) plus dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions. |
| Control Group | Active comparator | Other: RehabilitationConventional rehabilitation program (stretching, strengthening, balance) will be employed. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Hemiplegic, monoplegic, unilaterally affected or diplegic children aged 5-12 years with cerebral palsy
- Gross Motor Function Classification (GMFCS) level 1 (walks without restrictions) or 2 (walks with restrictions)
- Understand simple commands
- Signing the consent form
Key exclusion criteria (4 listed)
- Children and their families who do not want to be involved in the study
- Children with vision and hearing problems
- hildren with secondary orthopedic problems and children with walking aids
- Circumstances that would prevent carrying out assessments and exercise training or communicating
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 |
|---|---|---|
| RehabilitationConventional rehabilitation (stretching, strengthening, balance) and dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions. | Other | Control Group, Intervention Group |
Primary outcome
Pediatric Balance Scale (PBS)
Time frame: Change from Baseline PBS at 12 weeks
The scale consists of 14 items measuring parameters such as sitting balance and standing balance. Each item is ranked from 0 to 4. 0 indicates that the instruction cannot be fulfilled, while 4 indicates that it can be fulfilled without any difficulty. The maximum total score is 56.
Timed Up and Go Test (TUG)
Time frame: Change from Baseline TUG at 12 weeks
Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
One Leg Standing Test (OLST)
Time frame: Change from Baseline OLST at 12 weeks
Children are tested standing on one leg using their right and left leg respectively. The test is repeated on a hard surface with eyes open and closed. The child is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The child is asked to stand with one leg while keeping the other leg in a 90 degree flexion position. A stopwatch is used to record the time the child can hold the test position. The examiner ends the test if the child can hold the position for more than 30 seconds and records the elapsed time.
3-Meter Backward Walk Test (3MBWT)
Time frame: Change from Baseline 3MBWT at 12 weeks
A distance of 3 m was measured and marked with black tape. Children were asked to follow the black tape with their heels. They were asked to walk backwards quickly with the command 'start'. When the 3 m distance was completed, they were asked to stop. The assessor walked behind the individuals throughout the test.
6 Meter Walk Test (6MWT)
Time frame: Change from Baseline 6MWT at 12 weeks
A 6-meter track is determined. Children are asked to walk at a comfortable pace with the command "Start". The stopwatch is stopped by touching the finish line.
The Generic Children's Health-Related Quality of Life Questionnaire (KINDL)
Time frame: Change from Baseline KINDL at 12 weeks
The KINDL is a self-report questionnaire available for 3 different age groups: Kiddy-KINDL for children aged 4-7 years, Kid-KINDL for children aged 8-12 years and Kiddo-KINDL for adolescents aged 13-16 years. The total score ranges from 0-100. A higher score represents a better situation.
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 1 Sep 2023.
- 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.
İsmail Uysal, PhD study director
Muğla Sıtkı Koçman University
Fatih Özden, PhD principal investigator
Muğla Sıtkı Koçman University
İsmet Tümtürk, MSc principal investigator
Süleyman Demirel 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 Rehabilitation in people with Cerebral Palsy, run by Muğla Sıtkı Koçman 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 4 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 1 Sep 2023. 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?
Pediatric Balance Scale (PBS) (time frame: Change from Baseline PBS at 12 weeks). The study lists 6 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 1 Sep 2023.