Cerebral PalsyCP_TTNCT02097836
Targeted Training for Trunk Control_case Series Cerebral Palsy
A study testing Targeted Training in people with Cerebral Palsy and Traumatic Brain Injury, run by University of Oregon.
Trial summary
If a child with cerebral palsy does not develop independent sitting balance by 4 years of age, their prognosis for walking is very poor. Surprisingly little is known about how to facilitate head control or upright sitting balance and functional mobility in the child who is not developing these skills. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Cerebral Palsy, Traumatic Brain Injury
- What is being tested?
- Targeted Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Jan 2010
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neurologic diagnosis that results in a deficit in trunk control (i.e. cerebral palsy, traumatic brain injury)
- age 4-17 years
- Gross Motor Function Classification System (GMFCS) level III, IV or V for children with cerebral palsy
Who cannot join
- spinal fixation
- fixed scoliosis
- uncontrolled seizures
About this study
Official title: Segmental Training for Trunk Control a Pilot Study for Children With Moderate to Severe Motor Impairment.
If a child with cerebral palsy does not develop independent sitting balance by 4 years of age, their prognosis for walking is very poor. Surprisingly little is known about how to facilitate head control or upright sitting balance and functional mobility in the child who is not developing these skills. This is one of the first studies that will examine intermediate stages in the development of the postural control system in children with neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which trunk control is trained in children segment by segment using a specific training device. This study aims to examine kinematic and electromyographic changes in a case series of children who undergo a 6-month Targeted Training intervention.
- Conditions
- Cerebral Palsy, Traumatic Brain Injury
- Being tested
- Targeted Training
- Keywords
- postural control, Targeted Training, cerebral palsy, trunk segments
- Medical subject headings
- Cerebral Palsy, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted TrainingDevice
Custom training devices were imported from The Movement Centre for research purposes. 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.
| Study group | Role | What they receive |
|---|---|---|
| Single subject case series | Experimental | Targeted training, 5-6 days a week for 6 months, minimum of 20 minutes per day Receives: Device: Targeted Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function Measure
Measured: 6 months and followup post training 12 months
Probe data, balance
timed balance task
Measured: baseline, intervention, 2 months post intervention
Secondary outcomes (4)
Change in head stability
Change in alignment and stability of head postural sway during quiet sitting
Measured: 6 months, 1,3, and 12 months post intervention
Change in muscle activation strategy during quiet sitting with different levels of external support.
Measured: 6 months, 1 and 3 months post intervention
Change in Pediatric Evaluation of Disability Inventory (PEDI)
Measured: 6 months and 1,3, 12 months post intervention
Qualitative Parent, Teacher report
Measured: during intervention and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJan 2010
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra L Saavedra, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097836
- Sponsor's protocol ID
- CP_TT_2008
- Acronym
- CP_TT
- Status last verified
- Sep 2017
- First submitted
- 24 Mar 2014
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental Training for Trunk Control a Pilot Study for Children With Moderate to Severe Motor Impairment.
- ClinicalTrials.gov ID
- NCT02097836
- Acronym / sponsor ID
- CP_TT / CP_TT_2008
- Conditions
- Cerebral Palsy, Traumatic Brain Injury
- Keywords
- postural control, Targeted Training, cerebral palsy, trunk segments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Mar 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.
If a child with cerebral palsy does not develop independent sitting balance by 4 years of age, their prognosis for walking is very poor. Surprisingly little is known about how to facilitate head control or upright sitting balance and functional mobility in the child who is not developing these skills. This is one of the first studies that will examine intermediate stages in the development of the postural control system in children with neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which trunk control is trained in children segment by segment using a specific training device. This study aims to examine kinematic and electromyographic changes in a case series of children who undergo a 6-month Targeted Training intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single subject case series | Experimental | Device: Targeted TrainingTargeted training, 5-6 days a week for 6 months, minimum of 20 minutes per day |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- neurologic diagnosis that results in a deficit in trunk control (i.e. cerebral palsy, traumatic brain injury)
- age 4-17 years
- Gross Motor Function Classification System (GMFCS) level III, IV or V for children with cerebral palsy
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 TrainingCustom training devices were imported from The Movement Centre for research purposes. 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. | Device | Single subject case series |
Primary outcome
Change in Gross Motor Function Measure
Time frame: 6 months and followup post training 12 months
Probe data, balance
Time frame: baseline, intervention, 2 months post intervention
timed balance task
4 secondary outcomes
Change in head stability
Time frame: 6 months, 1,3, and 12 months post intervention
Change in muscle activation strategy during quiet sitting with different levels of external support.
Time frame: 6 months, 1 and 3 months post intervention
Change in Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: 6 months and 1,3, 12 months post intervention
Qualitative Parent, Teacher report
Time frame: during intervention and post intervention
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 14 Sep 2017.
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
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 L Saavedra, PhD principal investigator
University of Oregon
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Training in people with Cerebral Palsy and Traumatic Brain Injury, run by University of Oregon.
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 14 Sep 2017. 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 Gross Motor Function Measure (time frame: 6 months and followup post training 12 months). The study lists 2 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 14 Sep 2017.