Cerebral PalsyAPPLESNCT02567630
Early Childhood Constraint Therapy in Cerebral Palsy
A study testing Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy in people with Cerebral Palsy, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is a prospective interventional study involving young children who will all receive non-invasive, passive assessments of sensory and motor function. In addition a subpopulation of young children with cerebral palsy will participate in a randomized controlled trial of constraint-induced movement therapy, a… Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2015to 31 Dec 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 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- CP children (n=72): Inclusion criteria will be diagnosis of hemiparetic or asymmetric CP as determined by published algorithms and neurologic exam.
- TD children (n=144): Inclusion criteria will be GA and sex-matched compared to the CP group, with CA at assessment matched to the CP group at baseline (72 children) and at the 7-month assessment (72 children). Exclusion criteria will be any motor or sensory impairment as defined by neurologic exam and/or scaled motor scores below 8 for CA on the Bayley III and cognitive impairment or delays as described for the CP group.
Who cannot join
- CP children: exclusion criteria will be CP with Gross Motor Function Classification Score (GMFCS) of 4-5, corresponding to poor or absent mobility and neck control; receipt of Botox to the affected extremity within 3 months of study entry; or scores of <70 on the Bayley Scales of Infant Development (Bayley III) cognitive composite.
- TD children: Exclusion criteria will be any motor or sensory impairment as defined by neurologic exam and/or scaled motor scores below 8 for CA on the Bayley III and cognitive impairment or delays as described for the CP group.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Early Childhood Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy
This is a prospective interventional study involving young children who will all receive non-invasive, passive assessments of sensory and motor function. In addition a subpopulation of young children with cerebral palsy will participate in a randomized controlled trial of constraint-induced movement therapy, a routinely prescribed therapy used in clinical practice for children with motor difficulties. The study attempts to apply a rigorous scientific approach to study a widely used but poorly studied practice. The design is an RCT with wait-list controls to allow all children to benefit from the therapy, even if they are randomized to the control group. All children, regardless of group allocation will continue with their standard of care occupational and physical therapy throughout the study.
Read the detailed description
Cerebral palsy (CP) is the most common physical disability in childhood.1 It affects 3.6/100 children in the US2 with ~10,000 new diagnoses every year. The prevalence of CP in developing countries is estimated to be ~5-10 times greater. CP is a disorder resulting from sensory and motor impairments due to perinatal brain injury, with lifetime consequences that range from poor adaptive and social function to communication and emotional disturbances,9 all contributing to a shortened life expectancy. The societal costs are difficult to estimate but the financial burden is well over $1 M per life affected. A growing number of evidence-based therapies aim to improve gross motor function through changes in body structures and function in children with CP (e.g. hip surveillance, surgery). However, infants with CP have a fundamental disadvantage in recovering motor function: they do not receive accurate sensory feedback from their movements, leading to neglect of an affected extremity and difficulty learning new movements, a process called developmental disregard (DD). As a consequence, even children who receive time- and resource-intensive standard therapies have stable or declining motor function and developmental trajectories that do not "catch up" to those of typically developing children. DD can then lead to school-age learning problems, decreased participation in physical and social activities and costly long-term mental and physical morbidities.
Constraint-Induced Movement Therapy (CIMT) is one of the few effective neurorehabilitative strategies shown to improve upper extremity motor function in adults and older children with CP, potentially overcoming developmental disregard. It is mainly applicable to CP patients who are diagnosed with asymmetric or hemiparetic forms of the disorder, in which one side of the body is more affected than the other. CIMT is based on the premise that preferential use of an affected upper extremity (by constraining the less affected one), and shaping with repetition of movement by skilled therapists, can overcome neglect and restore function of that extremity.
The investigators are conducting a randomized trial of CIMT in children with CP using a wait-list control group. This design allows every child with CP to eventually receive the treatment and avoids issues of equipoise. The RCT portion of the study extends only for a 7-month period, from baseline to 6 months after the 1-month CIMT ends. For CP wait-listed controls, the study continues for 6 months following the CMIT intervention, separate from the completed RCT. We will reference data from both groups to a cohort of typically developing (TD) children to determine developmental trajectories.
- Conditions
- Cerebral Palsy
- Being tested
- Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral PalsyBehavioural
The CIMT intervention includes 3 components: (1) placement of a removable soft constraint for ½ each day, with a non-invasive wear monitor (2) demonstration and prescribed home-use of a sensory kit (3) and a reach/grasp tool. The intervention lasts 4 weeks as has been published in older children as well as used in infant trial descriptions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics of reach
We will use a motion analysis system tracks reflective markers at a rate of 240 Hz with spatial precision at the 1-mm level to capture movement in three-dimensional space. Markers will be positioned bilaterally on the head of the second metacarpal bone and on the object. Tracker software will be used to determine the three-dimensional position of the hand as it approaches each object, and to construct segments, angles and moments using Matlab software.
For each trial, approach velocity and movement units (marked by changes in speed or position) will be calculated. A single movement unit is defined as the portion of reach between one acceleration and another. The sum composite of movement units in one reach attempt is defined as smoothness. The motion tracking data will also be used to determine the time from presentation to first contact, time from first contact to grasp and approach velocity on the unilateral task.
Measured: Change from Baseline to Post intervention (1 month), and 6 months later
Somatosensory processing measurement by ERP
A high-density array of 128 electrodes embedded in soft sponges (Geodesic Sensor Net, EGI, Inc., Eugene, OR) will be used to record ERPs with a sampling rate of 1000 Hz, filters set to 0.1-400 Hz. All electrodes will be referred to Cz and re-referenced offline to an average reference. Recording of brainwaves will be controlled by Net Station (v. 4.3; EGI, Inc., Eugene, OR). E-Prime (v. 2.0, PST, Inc., Pittsburgh, PA) software will control stimulus delivery. Air puffs will be delivered using a custom-made apparatus with two flexible nozzles, one positioned approximately 0.5" below the palm of hand secured in a molded soft holder (puff condition), the other placed in proximity but directed away (sham condition). The pressure at the skin surface is 5 psi, or less than the pressure of the smallest microfilament used to test for neuropathies. For each hand, 60 puffs will be presented randomly interspersed with 60 sham trials.
Measured: Change from Baseline to Post intervention (1 month), and 6 months later
Bayley Scales of Infant and Toddler Development (Bayley III) - 3rd Edition
The Bayley III is the gold standard for the evaluation of former NICU graduates, and we have extensive experience using it in the Follow-Up Clinic. The motor scales provide a developmental and functional assessment, address unimanual as well as bimanual skills, are normed against a large population and designed to be adjusted for varying degrees of prematurity.
The Bayley fine motor items for 6-24 months (score range: 0-42) measure prehension, motor planning, grasping patterns, and eye-hand coordination. The examiner is masked to intervention vs. control group membership and administers the fine motor subscale twice, repeating unilateral items for right and left hands. Most (about 80%) of the Bayley fine motor items for infants aged 6 to 24 months require unilateral reach and grasp.
In addition to standard testing, separate scores will be obtained to characterize the difference between more and less affected extremity.
Measured: Change from Baseline to Post intervention (1 month), and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study start5 Oct 2015
- Primary completion31 Jan 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie Maitre, Nationwide Children's Hospital
- Investigators
- Nathalie L Maitre, MD, PhD, Principal investigator, Nationwide Childrens hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567630
- Sponsor's protocol ID
- IRB15-00547
- Acronym
- APPLES
- Status last verified
- Feb 2020
- First submitted
- 26 Aug 2015
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maitre NL, Jeanvoine A, Yoder PJ, Key AP, Slaughter JC, Carey H, Needham A, Murray MM, Heathcock J; BBOP group. Kinematic and Somatosensory Gains in Infants with Cerebral Palsy After a Multi-Component Upper-Extremity Intervention: A Randomized Controlled Trial. Brain Topogr. 2020 Nov;33(6):751-766. doi: 10.1007/s10548-020-00790-5. Epub 2020 Aug 3.
PubMed 32748303Chorna O, Heathcock J, Key A, Noritz G, Carey H, Hamm E, Nelin MA, Murray M, Needham A, Slaughter JC, Maitre NL. Early childhood constraint therapy for sensory/motor impairment in cerebral palsy: a randomised clinical trial protocol. BMJ Open. 2015 Dec 7;5(12):e010212. doi: 10.1136/bmjopen-2015-010212.
PubMed 26644127
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02567630
- Acronym / sponsor ID
- APPLES / IRB15-00547
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Oct 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.
This is a prospective interventional study involving young children who will all receive non-invasive, passive assessments of sensory and motor function. In addition a subpopulation of young children with cerebral palsy will participate in a randomized controlled trial of constraint-induced movement therapy, a routinely prescribed therapy used in clinical practice for children with motor difficulties. The study attempts to apply a rigorous scientific approach to study a widely used but poorly studied practice. The design is an RCT with wait-list controls to allow all children to benefit from the therapy, even if they are randomized to the control group. All children, regardless of group allocation will continue with their standard of care occupational and physical therapy throughout the study.
Detailed description
Cerebral palsy (CP) is the most common physical disability in childhood.1 It affects 3.6/100 children in the US2 with ~10,000 new diagnoses every year. The prevalence of CP in developing countries is estimated to be ~5-10 times greater. CP is a disorder resulting from sensory and motor impairments due to perinatal brain injury, with lifetime consequences that range from poor adaptive and social function to communication and emotional disturbances,9 all contributing to a shortened life expectancy. The societal costs are difficult to estimate but the financial burden is well over $1 M per life affected. A growing number of evidence-based therapies aim to improve gross motor function through changes in body structures and function in children with CP (e.g. hip surveillance, surgery). However, infants with CP have a fundamental disadvantage in recovering motor function: they do not receive accurate sensory feedback from their movements, leading to neglect of an affected extremity and difficulty learning new movements, a process called developmental disregard (DD). As a consequence, even children who receive time- and resource-intensive standard therapies have stable or declining motor function and developmental trajectories that do not "catch up" to those of typically developing children. DD can then lead to school-age learning problems, decreased participation in physical and social activities and costly long-term mental and physical morbidities.
Constraint-Induced Movement Therapy (CIMT) is one of the few effective neurorehabilitative strategies shown to improve upper extremity motor function in adults and older children with CP, potentially overcoming developmental disregard. It is mainly applicable to CP patients who are diagnosed with asymmetric or hemiparetic forms of the disorder, in which one side of the body is more affected than the other. CIMT is based on the premise that preferential use of an affected upper extremity (by constraining the less affected one), and shaping with repetition of movement by skilled therapists, can overcome neglect and restore function of that extremity.
The investigators are conducting a randomized trial of CIMT in children with CP using a wait-list control group. This design allows every child with CP to eventually receive the treatment and avoids issues of equipoise. The RCT portion of the study extends only for a 7-month period, from baseline to 6 months after the 1-month CIMT ends. For CP wait-listed controls, the study continues for 6 months following the CMIT intervention, separate from the completed RCT. We will reference data from both groups to a cohort of typically developing (TD) children to determine developmental trajectories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- CP children (n=72): Inclusion criteria will be diagnosis of hemiparetic or asymmetric CP as determined by published algorithms and neurologic exam.
- TD children (n=144): Inclusion criteria will be GA and sex-matched compared to the CP group, with CA at assessment matched to the CP group at baseline (72 children) and at the 7-month assessment (72 children). Exclusion criteria will be any motor or sensory impairment as defined by neurologic exam and/or scaled motor scores below 8 for CA on the Bayley III and cognitive impairment or delays as described for the CP group.
Key exclusion criteria (2 listed)
- CP children: exclusion criteria will be CP with Gross Motor Function Classification Score (GMFCS) of 4-5, corresponding to poor or absent mobility and neck control; receipt of Botox to the affected extremity within 3 months of study entry; or scores of <70 on the Bayley Scales of Infant Development (Bayley III) cognitive composite.
- TD children: Exclusion criteria will be any motor or sensory impairment as defined by neurologic exam and/or scaled motor scores below 8 for CA on the Bayley III and cognitive impairment or delays as described for the CP group.
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 |
|---|---|---|
| Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral PalsyThe CIMT intervention includes 3 components: (1) placement of a removable soft constraint for ½ each day, with a non-invasive wear monitor (2) demonstration and prescribed home-use of a sensory kit (3) and a reach/grasp tool. The intervention lasts 4 weeks as has been published in older children as well as used in infant trial descriptions. | Behavioural | – |
Primary outcome
Kinematics of reach
Time frame: Change from Baseline to Post intervention (1 month), and 6 months later
We will use a motion analysis system tracks reflective markers at a rate of 240 Hz with spatial precision at the 1-mm level to capture movement in three-dimensional space. Markers will be positioned bilaterally on the head of the second metacarpal bone and on the object. Tracker software will be used to determine the three-dimensional position of the hand as it approaches each object, and to construct segments, angles and moments using Matlab software. For each trial, approach velocity and movement units (marked by changes in speed or position) will be calculated. A single movement unit is defined as the portion of reach between one acceleration and another. The sum composite of movement units in one reach attempt is defined as smoothness. The motion tracking data will also be used to determine the time from presentation to first contact, time from first contact to grasp and approach velocity on the unilateral task.
Somatosensory processing measurement by ERP
Time frame: Change from Baseline to Post intervention (1 month), and 6 months later
A high-density array of 128 electrodes embedded in soft sponges (Geodesic Sensor Net, EGI, Inc., Eugene, OR) will be used to record ERPs with a sampling rate of 1000 Hz, filters set to 0.1-400 Hz. All electrodes will be referred to Cz and re-referenced offline to an average reference. Recording of brainwaves will be controlled by Net Station (v. 4.3; EGI, Inc., Eugene, OR). E-Prime (v. 2.0, PST, Inc., Pittsburgh, PA) software will control stimulus delivery. Air puffs will be delivered using a custom-made apparatus with two flexible nozzles, one positioned approximately 0.5" below the palm of hand secured in a molded soft holder (puff condition), the other placed in proximity but directed away (sham condition). The pressure at the skin surface is 5 psi, or less than the pressure of the smallest microfilament used to test for neuropathies. For each hand, 60 puffs will be presented randomly interspersed with 60 sham trials.
Bayley Scales of Infant and Toddler Development (Bayley III) - 3rd Edition
Time frame: Change from Baseline to Post intervention (1 month), and 6 months later
The Bayley III is the gold standard for the evaluation of former NICU graduates, and we have extensive experience using it in the Follow-Up Clinic. The motor scales provide a developmental and functional assessment, address unimanual as well as bimanual skills, are normed against a large population and designed to be adjusted for varying degrees of prematurity. The Bayley fine motor items for 6-24 months (score range: 0-42) measure prehension, motor planning, grasping patterns, and eye-hand coordination. The examiner is masked to intervention vs. control group membership and administers the fine motor subscale twice, repeating unilateral items for right and left hands. Most (about 80%) of the Bayley fine motor items for infants aged 6 to 24 months require unilateral reach and grasp. In addition to standard testing, separate scores will be obtained to characterize the difference between more and less affected extremity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Derived from this study: PubMed 32748303Maitre NL, Jeanvoine A, Yoder PJ, Key AP, Slaughter JC, Carey H, Needham A, Murray MM, Heathcock J; BBOP group. Kinematic and Somatosensory Gains in Infants with Cerebral Palsy After a Multi-Component Upper-Extremity Intervention: A Randomized Controlled Trial. Brain Topogr. 2020 Nov;33(6):751-766. doi: 10.1007/s10548-020-00790-5. Epub 2020 Aug 3.
- Derived from this study: PubMed 26644127Chorna O, Heathcock J, Key A, Noritz G, Carey H, Hamm E, Nelin MA, Murray M, Needham A, Slaughter JC, Maitre NL. Early childhood constraint therapy for sensory/motor impairment in cerebral palsy: a randomised clinical trial protocol. BMJ Open. 2015 Dec 7;5(12):e010212. doi: 10.1136/bmjopen-2015-010212.
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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.
Nathalie L Maitre, MD, PhD principal investigator
Nationwide Childrens hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy in people with Cerebral Palsy, run by Nationwide Children's Hospital 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 2 inclusion and 2 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 Feb 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?
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?
Kinematics of reach (time frame: Change from Baseline to Post intervention (1 month), and 6 months later). The study lists 3 primary outcomes in all. 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 NCT02567630, which also lists 2 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 18 Feb 2020.