Cerebral PalsyNCT04516265
Effects of Trunk Training in Patients With Cerebral Palsy
A study testing neurodevelopmental treatment, video-based trunk training and Video-based trunk training will apply with Theratogs in people with Cerebral Palsy, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to compare the effects of NGT-based trunk training, video-based trunk training and video-based trunk training applied with Theratogs in children with hemiparetic type Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- neurodevelopmental treatment, video-based trunk training and Video-based trunk training will apply with Theratogs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jul 2020to 21 Sep 2021
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with I-III levels according to Communication Function Classification System
- Patients with I-III levels according to GMFCS
- Patients with Hemiparetic Cerebral Palsy
- Continuing regular physiotherapy and rehabilitation program for six months.
Who cannot join
- Presence of visual or auditory impairment
- Presence of epilepsy
- Patients who have undergone orthopedic surgery in the last 6 months
- Patients who received Botulinum Toxin-A injection in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Effectiveness of Structured Trunk Training Protocols in Patients With Cerebral Palsy
The aim of our study is to compare the effects of NGT-based trunk training, video-based trunk training and video-based trunk training applied with Theratogs in children with hemiparetic type Cerebral Palsy.
Read the detailed description
The aim of our study is to compare the effects of NGT-based trunk training, video-based trunk training and video-based trunk training applied with Theratogs in children with hemiparetic type Cerebral Palsy. It is planned to include 45 patients with hemiparetic cerebral palsy between the ages of 5-15 and with Gross Motor Function Classification System (GMFCS) level I-III. Patients with cerebral palsy will be divided into 3 groups in a randomized controlled manner. Each group will continue and follow routine physiotherapy and rehabilitation treatments for 8 weeks. Then, structured trunk training will begin. NGT-based trunk training (45 minutes) to the first group, video-based trunk training (45 minutes) to the second group, and Video-based trunk training (45 minutes) will apply with Theratogs to the third group. Treatments will be applied two days a week for 8 weeks.
- Conditions
- Cerebral Palsy
- Being tested
- neurodevelopmental treatment, video-based trunk training, Video-based trunk training will apply with Theratogs
- Keywords
- trunk training, theratogs, exercise game, video-based training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurodevelopmental treatmentProcedure or surgery
A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.
video-based trunk trainingProcedure or surgery
Games developed for the use of children with cerebral palsy will be used for trunk training.
Video-based trunk training will apply with TheratogsProcedure or surgery
Video-based trunk training will apply with Theratogs
| Study group | Role | What they receive |
|---|---|---|
| NGT Group | Active comparator | A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment. Receives: Procedure: neurodevelopmental treatment |
| Video-based training group | Active comparator | Trunk training will be done with games developed for the use of children with cerebral palsy. Receives: Procedure: video-based trunk training |
| Video-based training group with theratogs | Active comparator | Video-based trunk training (45 minutes) will apply with Theratogs to the group Receives: Procedure: Video-based trunk training will apply with Theratogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Measurement Scale
It will be used to evaluate trunk control in patients with CP.
Measured: 8 weeks
Trunk Muscle Tone
Trunk Muscle Tone will be evaluated with the Myoton®PRO device.
Measured: 8 weeks
Segmental Assesment of Trunk Control Scale
It is an evaluation method that allows the body control to be evaluated from 3 different aspects as static, active and reactive control, according to trunk control levels.
Measured: 8 weeks
Balance Assessment System
The Fizyosoft Balance Assessment system, which works in harmony with the Nintendo Wii Balance Board, will be used in the assessment of the sitting balance.
Measured: 8 weeks
Secondary outcomes (3)
Pediatric Berg Balance Scale
It will be used to assess functional balance.
Measured: 8 weeks
10-meters walking test
It will be used to evaluate walking.
Measured: 8 weeks
Gillette Functional Gait Assessment Questionaire
It will be used to evaluate functional walking.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start21 Jul 2020
- Primary completion21 Jul 2021 (estimated)
- Study completion21 Sep 2021 (estimated)
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
- Model description
- Patients with cerebral palsy will be divided into 3 groups in a randomized controlled manner. Each group will continue and follow routine physiotherapy and rehabilitation treatments for 8 weeks. Then, structured trunk training will begin. NGT-based trunk training (45 minutes) to the first group, video-based trunk training (45 minutes) to the second group, and Video-based trunk training (45 minutes) will apply with Theratogs to the third group. Treatments will be applied two days a week for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Azim Rezaei, Okan University
- Investigators
- Derya Azim Rezaei, MSc, Principal investigator, Okan University,Faculty of Health Sciences,Department of Physiotherapy and RehabilitationBurcu Ersöz Hüseyinsinoğlu, Associate professor, Study director, Istanbul University-Cerrahpaşa,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516265
- Sponsor's protocol ID
- Okan U
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 18 Aug 2020
- 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 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Effectiveness of Structured Trunk Training Protocols in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04516265
- Acronym / sponsor ID
- Okan U
- Conditions
- Cerebral Palsy
- Keywords
- trunk training, theratogs, exercise game, video-based training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 21 Jul 2021 (estimated)
- Study completion
- 21 Sep 2021 (estimated)
- First posted
- 18 Aug 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.
The aim of our study is to compare the effects of NGT-based trunk training, video-based trunk training and video-based trunk training applied with Theratogs in children with hemiparetic type Cerebral Palsy.
Detailed description
The aim of our study is to compare the effects of NGT-based trunk training, video-based trunk training and video-based trunk training applied with Theratogs in children with hemiparetic type Cerebral Palsy. It is planned to include 45 patients with hemiparetic cerebral palsy between the ages of 5-15 and with Gross Motor Function Classification System (GMFCS) level I-III. Patients with cerebral palsy will be divided into 3 groups in a randomized controlled manner. Each group will continue and follow routine physiotherapy and rehabilitation treatments for 8 weeks. Then, structured trunk training will begin. NGT-based trunk training (45 minutes) to the first group, video-based trunk training (45 minutes) to the second group, and Video-based trunk training (45 minutes) will apply with Theratogs to the third group. Treatments will be applied two days a week for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients with cerebral palsy will be divided into 3 groups in a randomized controlled manner. Each group will continue and follow routine physiotherapy and rehabilitation treatments for 8 weeks. Then, structured trunk training will begin. NGT-based trunk training (45 minutes) to the first group, video-based trunk training (45 minutes) to the second group, and Video-based trunk training (45 minutes) will apply with Theratogs to the third group. Treatments will be applied two days a week for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| NGT Group | Active comparator | Procedure: neurodevelopmental treatmentA personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment. |
| Video-based training group | Active comparator | Procedure: video-based trunk trainingTrunk training will be done with games developed for the use of children with cerebral palsy. |
| Video-based training group with theratogs | Active comparator | Procedure: Video-based trunk training will apply with TheratogsVideo-based trunk training (45 minutes) will apply with Theratogs to the group |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with I-III levels according to Communication Function Classification System
- Patients with I-III levels according to GMFCS
- Patients with Hemiparetic Cerebral Palsy
- Continuing regular physiotherapy and rehabilitation program for six months.
Key exclusion criteria (4 listed)
- Presence of visual or auditory impairment
- Presence of epilepsy
- Patients who have undergone orthopedic surgery in the last 6 months
- Patients who received Botulinum Toxin-A injection 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 |
|---|---|---|
| neurodevelopmental treatmentA personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment. | Procedure or surgery | NGT Group |
| video-based trunk trainingGames developed for the use of children with cerebral palsy will be used for trunk training. | Procedure or surgery | Video-based training group |
| Video-based trunk training will apply with TheratogsVideo-based trunk training will apply with Theratogs | Procedure or surgery | Video-based training group with theratogs |
Primary outcome
Trunk Control Measurement Scale
Time frame: 8 weeks
It will be used to evaluate trunk control in patients with CP.
Trunk Muscle Tone
Time frame: 8 weeks
Trunk Muscle Tone will be evaluated with the Myoton®PRO device.
Segmental Assesment of Trunk Control Scale
Time frame: 8 weeks
It is an evaluation method that allows the body control to be evaluated from 3 different aspects as static, active and reactive control, according to trunk control levels.
Balance Assessment System
Time frame: 8 weeks
The Fizyosoft Balance Assessment system, which works in harmony with the Nintendo Wii Balance Board, will be used in the assessment of the sitting balance.
3 secondary outcomes
Pediatric Berg Balance Scale
Time frame: 8 weeks
10-meters walking test
Time frame: 8 weeks
Gillette Functional Gait Assessment Questionaire
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- 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.
Derya Azim Rezaei, MSc principal investigator
Okan University,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
Burcu Ersöz Hüseyinsinoğlu, Associate professor study director
Istanbul University-Cerrahpaşa,Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurodevelopmental treatment, video-based trunk training and Video-based trunk training will apply with Theratogs in people with Cerebral Palsy, run by Okan 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: status not confirmed, as of the sponsor's last update on 18 Aug 2020. 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?
Results are not available in the source record.
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?
Trunk Control Measurement Scale (time frame: 8 weeks). The study lists 4 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 18 Aug 2020.