Cerebral PalsyCP_TT_UHartNCT02246751
Case Series_Targeted Training for Trunk Control Cerebral Palsy
A study of Cerebral Palsy, run by University of Hartford at 1 site in United States.
Trial summary
Little is known about how children with cerebral palsy (CP) use their sensory systems (touch, sense of body position, balance organs in the inner ear, vision) to help them achieve trunk control for independent sitting. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cerebral Palsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 30 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cerebral palsy
- age 2-12 years
- Gross Motor Function Classification System (GMFCS) Level III, IV or V
Who cannot join
- spinal fixation
- fixed scoliosis
- uncontrolled seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Balance Laboratory; University of Hartford;
West Hartford, Connecticut, 06117
About this study
Official title: Effect of Targeted Training on Sensorimotor Control of Trunk Posture
Little is known about how children with cerebral palsy (CP) use their sensory systems (touch, sense of body position, balance organs in the inner ear, vision) to help them achieve trunk control for independent sitting. If a child with CP does not achieve trunk control by 4 years of age their prognosis for motor skill development including walking is poor. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which children train trunk control in small segments from the top down using a custom fit training device. This study aims to examine how children with moderate to severe CP use sensory information for trunk control before, during and after a program of Targeted Training.
Read the detailed description
One of the major challenges of motor control is to understand how the central nervous system controls the degrees of freedom of the body. This is particularly evident in cerebral palsy (CP), which is the most prevalent chronic childhood motor disability and is one of the most disabling and costly chronic disorders of children and adults. Deficits in postural control and sensorimotor integration are hallmarks of CP. Although postural control of the trunk for independent sitting creates the foundation for all other motor tasks, surprisingly little is known about how children with CP use sensory input to guide their development of upright control (which occurs in typically developing infants by 8 months of age). This lack of knowledge limits our ability to effectively assess and treat children with neuromotor deficits in trunk control.
The objectives of this project are to identify sensory reliance and sensory re-weighting in a study of children with moderate-to-severe CP (4-12 years of age) before and after Targeted Training for Trunk Control. A novel trunk support device will enable testing of participants who lack (or are still developing) stable sitting. In experiments, kinematics of the head and trunk will be measured. Sensory reliance and re-weighting will be identified from postural trunk responses to sensory conflict stimuli consisting of tilts of a visual surround and/or tilts of a surface which participants sit upon. Generally, participants with a high reliance on vestibular feedback will remain upright with respect to gravity during all tests; whereas a high reliance on cutaneous or visual feedback will produce trunk sway away from upright and toward the surface or visual surround tilt, respectively. To tease apart biomechanical, physical, and neurological contributions to trunk sway, sensorimotor integration modeling will be used to complement data interpretation.
- Conditions
- Cerebral Palsy
- Being tested
- Targeted Training for trunk control
- Keywords
- postural control, Targeted Training, cerebral palsy, sensorimotor control, trunk segments
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Training for trunk controlDevice
Also called Segmental training for trunk control
Orthotics Research and Locomotor Research Unit (ORLAU) standers will be custom fit to help the child train at the segmental level of the trunk where they begin to lose control of posture. The typical course of treatment involves loaning the customized equipment to each family for use in their home or in their child's educational setting. Training occurs once daily usually for 30-45 minutes. This is done 5 or 6 days per week. Training programs typically involve playing with balls or balloons or video games that motivate the child to hold the head erect and to wave the arms and hands and move the upper body. The researchers evaluate children every 8 weeks and adjust the stander to lower levels of support as the child gains control.
| Study group | Role | What they receive |
|---|---|---|
| Single subject design case series | Experimental | Targeted Training for trunk control, 5-6 days a week for 9 months, minimum of 20 minutes per day. Receives: Device: Targeted Training for trunk control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sensory motor processes
Change in sensory motor processes as evidenced by kinematic measures during sitting balance perturbation tasks.
Measured: 9 months and 1 and 3 months post training
Secondary outcomes (2)
Change in gross motor functional skills (e.g. sitting, crawling, standing)
The Gross Motor Function Measure (GMFM 66) is a standardized test of gross motor function that has been validated for children with cerebral palsy
Measured: 9 months and 1 & 3 months post training
Segmental Assessment of Trunk Control
Change in the trunk segment where static, active or reactive control is lost.
Measured: 2, 4, 6, 8 and 9 months and 1 & 3 months post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Saavedra, MS, PT, PhD, Principal investigator, University of HartfordAdam Goodworth, MS, PhD, Principal investigator, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246751
- Sponsor's protocol ID
- CP_TT_2014
- Acronym
- CP_TT_UHart
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2014
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Goodworth AD, Peterka RJ. Sensorimotor integration for multisegmental frontal plane balance control in humans. J Neurophysiol. 2012 Jan;107(1):12-28. doi: 10.1152/jn.00670.2010. Epub 2011 Sep 21.
PubMed 21940611Goodworth AD, Peterka RJ. Contribution of sensorimotor integration to spinal stabilization in humans. J Neurophysiol. 2009 Jul;102(1):496-512. doi: 10.1152/jn.00118.2009. Epub 2009 Apr 29.
PubMed 19403751Saavedra SL, van Donkelaar P, Woollacott MH. Learning about gravity: segmental assessment of upright control as infants develop independent sitting. J Neurophysiol. 2012 Oct;108(8):2215-29. doi: 10.1152/jn.01193.2011. Epub 2012 Jul 25.
PubMed 22832568Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.
PubMed 20699770
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Targeted Training on Sensorimotor Control of Trunk Posture
- ClinicalTrials.gov ID
- NCT02246751
- Acronym / sponsor ID
- CP_TT_UHart / CP_TT_2014
- Conditions
- Cerebral Palsy
- Keywords
- postural control, Targeted Training, cerebral palsy, sensorimotor control, trunk segments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 23 Sep 2014 (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.
Little is known about how children with cerebral palsy (CP) use their sensory systems (touch, sense of body position, balance organs in the inner ear, vision) to help them achieve trunk control for independent sitting. If a child with CP does not achieve trunk control by 4 years of age their prognosis for motor skill development including walking is poor. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which children train trunk control in small segments from the top down using a custom fit training device. This study aims to examine how children with moderate to severe CP use sensory information for trunk control before, during and after a program of Targeted Training.
Detailed description
One of the major challenges of motor control is to understand how the central nervous system controls the degrees of freedom of the body. This is particularly evident in cerebral palsy (CP), which is the most prevalent chronic childhood motor disability and is one of the most disabling and costly chronic disorders of children and adults. Deficits in postural control and sensorimotor integration are hallmarks of CP. Although postural control of the trunk for independent sitting creates the foundation for all other motor tasks, surprisingly little is known about how children with CP use sensory input to guide their development of upright control (which occurs in typically developing infants by 8 months of age). This lack of knowledge limits our ability to effectively assess and treat children with neuromotor deficits in trunk control.
The objectives of this project are to identify sensory reliance and sensory re-weighting in a study of children with moderate-to-severe CP (4-12 years of age) before and after Targeted Training for Trunk Control. A novel trunk support device will enable testing of participants who lack (or are still developing) stable sitting. In experiments, kinematics of the head and trunk will be measured. Sensory reliance and re-weighting will be identified from postural trunk responses to sensory conflict stimuli consisting of tilts of a visual surround and/or tilts of a surface which participants sit upon. Generally, participants with a high reliance on vestibular feedback will remain upright with respect to gravity during all tests; whereas a high reliance on cutaneous or visual feedback will produce trunk sway away from upright and toward the surface or visual surround tilt, respectively. To tease apart biomechanical, physical, and neurological contributions to trunk sway, sensorimotor integration modeling will be used to complement data interpretation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single subject design case series | Experimental | Device: Targeted Training for trunk controlTargeted Training for trunk control, 5-6 days a week for 9 months, minimum of 20 minutes per day. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- cerebral palsy
- age 2-12 years
- Gross Motor Function Classification System (GMFCS) Level III, IV or V
Key exclusion criteria (3 listed)
- spinal fixation
- fixed scoliosis
- uncontrolled seizures
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 |
|---|---|---|
| Targeted Training for trunk controlAlso: Segmental training for trunk controlOrthotics Research and Locomotor Research Unit (ORLAU) standers will be custom fit to help the child train at the segmental level of the trunk where they begin to lose control of posture. The typical course of treatment involves loaning the customized equipment to each family for use in their home or in their child's educational setting. Training occurs once daily usually for 30-45 minutes. This is done 5 or 6 days per week. Training programs typically involve playing with balls or balloons or video games that motivate the child to hold the head erect and to wave the arms and hands and move the upper body. The researchers evaluate children every 8 weeks and adjust the stander to lower levels of support as the child gains control. | Device | Single subject design case series |
Primary outcome
Change in sensory motor processes
Time frame: 9 months and 1 and 3 months post training
Change in sensory motor processes as evidenced by kinematic measures during sitting balance perturbation tasks.
2 secondary outcomes
Change in gross motor functional skills (e.g. sitting, crawling, standing)
Time frame: 9 months and 1 & 3 months post training
Segmental Assessment of Trunk Control
Time frame: 2, 4, 6, 8 and 9 months and 1 & 3 months post training
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 7 Sep 2020.
- Background: PubMed 21940611Goodworth AD, Peterka RJ. Sensorimotor integration for multisegmental frontal plane balance control in humans. J Neurophysiol. 2012 Jan;107(1):12-28. doi: 10.1152/jn.00670.2010. Epub 2011 Sep 21.
- Background: PubMed 19403751Goodworth AD, Peterka RJ. Contribution of sensorimotor integration to spinal stabilization in humans. J Neurophysiol. 2009 Jul;102(1):496-512. doi: 10.1152/jn.00118.2009. Epub 2009 Apr 29.
- Background: PubMed 22832568Saavedra SL, van Donkelaar P, Woollacott MH. Learning about gravity: segmental assessment of upright control as infants develop independent sitting. J Neurophysiol. 2012 Oct;108(8):2215-29. doi: 10.1152/jn.01193.2011. Epub 2012 Jul 25.
- Background: PubMed 20699770Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.
- 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.
Sandra Saavedra, MS, PT, PhD principal investigator
University of Hartford
Adam Goodworth, MS, PhD principal investigator
University of Hartford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cerebral Palsy, run by University of Hartford at 1 site in United States.
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 3 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 7 Sep 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 United States. 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?
Change in sensory motor processes (time frame: 9 months and 1 and 3 months post training). 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 NCT02246751, which also lists 4 linked publications.
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 7 Sep 2020.