Cerebral Palsy, SpasticFTTNCT02643160
Analyzing the Effect of Trunk Training on Limbs in Children With Spastic Cerebral Palsy
A study testing Functional Trunk Training in people with Cerebral Palsy, Spastic, run by Abant Izzet Baysal University.
Trial summary
The purpose of this study is to analyze if trunk training has effects on trunk, upper, lower extremity motor functions in children with spastic Cerebral Palsy. Second purpose is to analyze the relation between trunk control and prematurity, birth weight, upper and lower extremity motor functions in children with… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Functional Trunk Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 2015
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with spastic cerebral palsy effected bilaterally
- Between 4-18 years age
Who cannot join
- Received orthopedic surgery during last 6 weeks
- Receive Botulinum Toxin injection during last 6 weeks
- Mentally retarded children with communication limitations
- Had epileptic seizures during last 12 moths -
About this study
Official title: Analyzing the Effect of Functional Trunk Training on Upper and Lower Limb Motor Function in Children With Spastic Cerebral Palsy
The purpose of this study is to analyze if trunk training has effects on trunk, upper, lower extremity motor functions in children with spastic Cerebral Palsy. Second purpose is to analyze the relation between trunk control and prematurity, birth weight, upper and lower extremity motor functions in children with spastic Cerebral Palsy.
Read the detailed description
Cerebral Palsy (CP) is a condition caused by a lesion occurred in immature brain during prenatal, natal or postnatal period. Children with CP may have motor, cognitive, sensory, auditory, behavioral problems during their lifespan. Spastic type CP is most common type of CP and many children with spastic CP have both trunk and limb impairment. Physiotherapy is very important for improving motor function and protect from secondary impairments in this children and should start as early as possible. The aim of this study is to analyze if trunk training has effects on trunk, upper and lower extremity motor function in children with spastic CP. 38 children with spastic CP between 4-18 years age are included in this study. Both genders are included. The Participants randomized according to their gross motor function classification system levels and their age. Before intervention all groups assessed with assessment tools which assess muscle spasticity, balance, gross motor function, trunk control and walking characteristics. After randomization there wasn't any intervention for control group; they continued their regular physiotherapy in special education centers two times a week. Study group received trunk training two times a week in addition to their regular physiotherapy in special education centers during 8 weeks. After 8 weeks all groups assessed with the same assessment tools.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Functional Trunk Training
- Keywords
- Trunk Training, Motor Function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Trunk TrainingOther
The intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region
| Study group | Role | What they receive |
|---|---|---|
| Functional Trunk Training Group | Experimental | Functional Trunk Training which includes strengthening of trunk muscle and functional activities including trunk region. Receives: Other: Functional Trunk Training |
| Control Group | No intervention | No intervention, the continued their regular physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trunk control over time assessed with Trunk Control Measurement Scale.
Assessing change in trunk control
Measured: At baseline and 8 weeks after baseline
Secondary outcomes (12)
Change in daily living activities and participation over time assessed with Child Health Questionary Parent Form 50.
Assessment of child's daily living activities and participation
Measured: At baseline and 8 weeks after baseline
Change in muscle activation over time assessed with Surface Electromyography.
Assessment of muscle activation
Measured: At baseline and 8 weeks after baseline
Change in muscle spasticity over time assessed with Modified Tardieu Scale.
Assessing muscle spasticity
Measured: At baseline and 8 weeks after baseline
Change in gross motor function over time assessed with Gross Motor Function Measurement
Assessing gross motor function
Measured: At baseline and 8 weeks after baseline
Change in upper extremity skills over time assessed with Quality of Upper Extremity Skills Test
Assessing upper extremity skills
Measured: At baseline and 8 weeks after baseline
Change in loco motion over time assessed with Gillette Functional Assessment Scale
Assessing loco motion.
Measured: At baseline and 8 weeks after baseline
Change in walking parameters over time assessed with Physicians Rating Scale
Assessing walking parameters
Measured: At baseline and 8 weeks after baseline
Change in functional loco motion over time assessed with Timed Up and Go Test
Assessing functional loco motion
Measured: At baseline and 8 weeks after baseline
Change in walking speed over time assessed with 1 Minute Walk Test
Assessing walking speed
Measured: At baseline and 8 weeks after baseline
Change in balance over time assessed with Pediatric Balance Scale
Assessing balance
Measured: At baseline and 8 weeks after baseline
Change in impact of having a disabled child on family over time assessed with Impact on Family Scale
Assessing impact on family to have a disabled child
Measured: At baseline and 8 weeks after baseline
Change in independence level over time assessed with Functional Independence Measure for Kids
Assessing independence level
Measured: At baseline and 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionOct 2015
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 Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor
- Investigators
- Mintaze KEREM GÜNEL, Professor, Study director, Hacettepe University, Graduate School of Health Sciences, Physical Therapy and Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643160
- Sponsor's protocol ID
- GO 14 135
- Acronym
- FTT
- Status last verified
- Dec 2015
- First submitted
- 25 Nov 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heyrman L, Molenaers G, Desloovere K, Verheyden G, De Cat J, Monbaliu E, Feys H. A clinical tool to measure trunk control in children with cerebral palsy: the Trunk Control Measurement Scale. Res Dev Disabil. 2011 Nov-Dec;32(6):2624-35. doi: 10.1016/j.ridd.2011.06.012. Epub 2011 Jul 14.
PubMed 21757321
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Effect of Functional Trunk Training on Upper and Lower Limb Motor Function in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02643160
- Acronym / sponsor ID
- FTT / GO 14 135
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Trunk Training, Motor Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 31 Dec 2015 (estimated)
- 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 purpose of this study is to analyze if trunk training has effects on trunk, upper, lower extremity motor functions in children with spastic Cerebral Palsy. Second purpose is to analyze the relation between trunk control and prematurity, birth weight, upper and lower extremity motor functions in children with spastic Cerebral Palsy.
Detailed description
Cerebral Palsy (CP) is a condition caused by a lesion occurred in immature brain during prenatal, natal or postnatal period. Children with CP may have motor, cognitive, sensory, auditory, behavioral problems during their lifespan. Spastic type CP is most common type of CP and many children with spastic CP have both trunk and limb impairment. Physiotherapy is very important for improving motor function and protect from secondary impairments in this children and should start as early as possible. The aim of this study is to analyze if trunk training has effects on trunk, upper and lower extremity motor function in children with spastic CP. 38 children with spastic CP between 4-18 years age are included in this study. Both genders are included. The Participants randomized according to their gross motor function classification system levels and their age. Before intervention all groups assessed with assessment tools which assess muscle spasticity, balance, gross motor function, trunk control and walking characteristics. After randomization there wasn't any intervention for control group; they continued their regular physiotherapy in special education centers two times a week. Study group received trunk training two times a week in addition to their regular physiotherapy in special education centers during 8 weeks. After 8 weeks all groups assessed with the same assessment tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Trunk Training Group | Experimental | Other: Functional Trunk TrainingFunctional Trunk Training which includes strengthening of trunk muscle and functional activities including trunk region. |
| Control Group | No intervention | –No intervention, the continued their regular physical therapy |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children with spastic cerebral palsy effected bilaterally
- Between 4-18 years age
Key exclusion criteria (4 listed)
- Received orthopedic surgery during last 6 weeks
- Receive Botulinum Toxin injection during last 6 weeks
- Mentally retarded children with communication limitations
- Had epileptic seizures during last 12 moths -
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 |
|---|---|---|
| Functional Trunk TrainingThe intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region | Other | Functional Trunk Training Group |
Primary outcome
Change in trunk control over time assessed with Trunk Control Measurement Scale.
Time frame: At baseline and 8 weeks after baseline
Assessing change in trunk control
12 secondary outcomes
Change in daily living activities and participation over time assessed with Child Health Questionary Parent Form 50.
Time frame: At baseline and 8 weeks after baseline
Change in muscle activation over time assessed with Surface Electromyography.
Time frame: At baseline and 8 weeks after baseline
Change in muscle spasticity over time assessed with Modified Tardieu Scale.
Time frame: At baseline and 8 weeks after baseline
Change in gross motor function over time assessed with Gross Motor Function Measurement
Time frame: At baseline and 8 weeks after baseline
Change in upper extremity skills over time assessed with Quality of Upper Extremity Skills Test
Time frame: At baseline and 8 weeks after baseline
Change in loco motion over time assessed with Gillette Functional Assessment Scale
Time frame: At baseline and 8 weeks after baseline
Change in walking parameters over time assessed with Physicians Rating Scale
Time frame: At baseline and 8 weeks after baseline
Change in functional loco motion over time assessed with Timed Up and Go Test
Time frame: At baseline and 8 weeks after baseline
Change in walking speed over time assessed with 1 Minute Walk Test
Time frame: At baseline and 8 weeks after baseline
Change in balance over time assessed with Pediatric Balance Scale
Time frame: At baseline and 8 weeks after baseline
Change in impact of having a disabled child on family over time assessed with Impact on Family Scale
Time frame: At baseline and 8 weeks after baseline
Change in independence level over time assessed with Functional Independence Measure for Kids
Time frame: At baseline and 8 weeks after baseline
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 31 Dec 2015.
- Results publication: PubMed 21757321Heyrman L, Molenaers G, Desloovere K, Verheyden G, De Cat J, Monbaliu E, Feys H. A clinical tool to measure trunk control in children with cerebral palsy: the Trunk Control Measurement Scale. Res Dev Disabil. 2011 Nov-Dec;32(6):2624-35. doi: 10.1016/j.ridd.2011.06.012. Epub 2011 Jul 14.
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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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.
Mintaze KEREM GÜNEL, Professor study director
Hacettepe University, Graduate School of Health Sciences, Physical Therapy and Rehabilitation Department
Questions about this trial
What is this clinical trial studying?
A study testing Functional Trunk Training in people with Cerebral Palsy, Spastic, run by Abant Izzet Baysal University.
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 2 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 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in trunk control over time assessed with Trunk Control Measurement Scale. (time frame: At baseline and 8 weeks after baseline). 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 NCT02643160, 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 31 Dec 2015.