Clinical Trials by Geographic Location

Clinical Trials Highlighted By Region - September 2022

The Cerebral Palsy Foundation is committed to sharing the most up to date Cerebral Palsy clinical trial and research study information with you on an ongoing basis. 

Every month we'll highlight new or innovative clinical trials around the United States that may be a fit for you or your family member.  Check back often for what's new and exciting in the world of cerebral palsy research.

Currently, there are 73 clinical trails actively recruiting participants around the United States in different geographic locations. We have highlighted a few below. You can click on each link to learn more about the trial or study, including where it is located and what medical or research institution is involved.  We've included research studies and trials focusing on both children and adults with different types of cerebral palsy.

IMPORTANT: * ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine. Listing a study on ClinicalTrials.gov does not mean it has been evaluated by the Cerebral Palsy Foundation and does not constitute medical advice.  Before participating in a study, talk to your health care provider and learn about the risks and potential benefits.

Nationwide and NIH Based Clinical Studies
Map of the United States colored blue to indicate multistate or NIH based studies
1) Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders

Study Description

Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch gait, an abnormal way of walking. Knee crouch has many causes, so no single device or approach works best for everybody. This study's adjustable brace provides many types of walking assistance. Researchers will evaluate brace options to find the best solution for each participant, and whether one solution works best for the group.

Three forms of assistance will be provided at the knee joint including a passive-damper component, functional electrical stimulation (FES) to the quadriceps, and a motorized assist. One form will provide controllable resistance at the knee to strengthen muscles and promote knee extension after the resistance is removed. These will be compared to traditional bracing which typically improves crouch by blocking some or all motion at one or both joints. We hypothesize that all assistive configurations will improve gait alignment and performance compared to the non-assisted conditions. We further hypothesize that a best solution for each participant will exist, but may vary across subjects due to the heterogeneity of these movement disorders. 

https://www.clinicaltrials.gov/ct2/show/NCT01961557

Eligibility:

  • Children 5 - 17 years old with CP.
  • Healthy volunteers 5 - 17 years old.

Contacts: Jesse H Matsubara(301) 451-7530  jesse.matsubara@nih.gov  and Thomas C Bulea, M.D.(301) 451-7533 buleatc@mail.nih.gov

2) Dopamine and Motor Learning in Cerebral Palsy

Study Description

Cerebral palsy (CP) is the most common lifelong motor disability. Dopamine (DA) is a neurotransmitter that plays a role in cognition, emotions, and behavior. DA may also play a role in motor skill learning. Genes associated with DA function may impair an individual's ability to learn new cognitive or motor skills. Some children with CP learn motor skills quickly, while others struggle. Researchers at the National Institutes of Health want to know if DA gene variations are to blame for some of this variation.

https://clinicaltrials.gov/ct2/show/NCT02839733

Eligibility:

  • People ages 5-25 with and without CP who can follow the protocol and attend and perform training sessions

Contacts: Mayra J Medrano (301) 451-7529 mayra.medrano@nih.gov and Diane L Damiano, Ph.D. (301) 451-7544 damianod@cc.nih.gov

3) Cerebral Palsy Hip Outcomes Project - International Multi-Center Study

Study Description

The primary goal of this project is to assess the efficacy of various intervention strategies in preventing or alleviating symptoms associated with hip instability in children with severe cerebral palsy, with the validated Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire serving as the primary outcome measure of health-related quality of life for this population.

https://clinicaltrials.gov/ct2/show/NCT01987882t

Eligibility:

  • 2-18 year olds with a working diagnosis of cerebral palsy or cerebral palsy-like condition
  • A migration percentage ≥ 30%
  • Non-ambulatory; the primary mode of mobility is a wheelchair
  • Parent/primary caregiver must understand one of the languages in which the CPCHILD has been translated, culturally adapted and validated.

Contacts: Dr. Unni Narayanan, MBBS, MSc, FRCSC unni.narayanan@sickkids.ca and Ashley Ferkul, BA ashley.ferkul@sickkids.ca

4) Perinatal Arterial Stroke: A Multi-Site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

Study Description

The proposed study is a Phase III trial designed to assess the efficacy of two different doses of I-ACQUIRE for children 8 to 36 months with PAS and hemiparesis. 240 children will be randomly assigned to one of 3 treatment groups (N=80 per group). 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity.

https://clinicaltrials.gov/ct2/show/NCT03910075

Eligibility:

  • Child between 8-36 months with hemiparesis and a diagnosis of Perinatal Arterial Stroke (PAS)
  • Parental permission to provide the child's clinical MRI to the study
  • Parent(s) willing to participate in the home therapy component
  • One parent English language proficient and will take the lead in interacting with study staff and completing self-administered forms and interviews in English

Contacts: Laura Bateman, B.S. 540-526-2033 laurapb2@vt.edu and Stephanie DeLuca, Ph.D. 540-526-2098 Stephdeluca@vt.edu

5) Neonatal Seizure Registry - Developmental Functional Evaluation (NSR-DEV)

Study Description

Neonatal seizures due to brain injury are associated with high risk of neurodevelopmental disability in infancy. Although prognosis in early childhood is a critical question for parents and providers, outcomes beyond infancy are generally unknown. Further, parents of infants with neonatal seizures are at risk for mental health disorders, which can undermine their ability to care for a child with medical complexity and may contribute to impaired child development. Participants will be enrolled at one of nine sites across the USA and evaluated using developmental questionnaires and in-person neurodevelopmental testing. Parent well-being will be assessed at each time point.

https://clinicaltrials.gov/ct2/show/NCT04337697

Eligibility:

  • Children who are 2-8 years old enrolled in NSR-II
  • Alive at the start of the NSR-DEV study period
  • Parent(s) who are English or Spanish literate (with assistance of interpreter)

Contacts: Hannah C. Glass, MDCM, MAS 415-476-3785 hannah.glass@ucsf.edu and Yasmeen A. Rezaishad, BS 415-476-3785 yasmeen.rezaishad@ucsf.edu

6) Pain Burden in Children and Adolescents with Cerebral Palsy (CPPain)

Study Description

Pain in children and adolescents with cerebral palsy (CP) is a significant health challenge that so far has received too little attention. The goal of the CPPain program is to reduce the pain experience and effects of children and adolescents living with CP. The purpose of basic data collection is to provide in-depth knowledge of the pain burden of children and adolescents with CP.This knowledge is needed to develop targeted pain-relieving interventions for this vulnerable group of children, who are burdened with the challenges associated with chronic illness. In the next step, nested intervention will be co-created with children and adolescents with CP, their parents as well as health care professionals, and other professional caregivers involved in or responsible for management of pain based on existing research and baseline findings.

https://clinicaltrials.gov/ct2/show/NCT04219020

Eligibility:

  • Children 0-18 years with a CP diagnosis registered in the Cerebral Palsy Registry of Norway (CPRN), or recruited through child habilitation centers, patient organizations or social media advertising campaigns (USA, Canada, Finland & Sweden)
  • Siblings 12-18 years of a child/adolescent with CP (survey only)
  • Clinicians identified by parents and/or children with CP as providers of pain-related care

Contacts: Randi Dovland Andersen, PhD +47 934 53 441 and Olav Aga Kildal, MD +47 477 06 094

7) Cerebral Palsy and the Study of Brain Activity During Motor Tasks

Study Description

Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS) and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it is active. EEG records electrical activity in the brain. Both have been used safely for many years, even in very young children. NIRS or EEG can be used while a person is moving to show which parts of the brain are the most active. Researchers want to use NIRS and EEG to study brain activity during movement in people with cerebral palsy and healthy volunteers. Learning more about how people with and without cerebral palsy use their brain to control their muscles may lead to new ways of training people with cerebral palsy to move better.

https://www.clinicaltrials.gov/ct2/show/NCT01829724

Eligibility:

  • Individuals at least 5 years of age who have cerebral palsy.
  • Healthy volunteers at least 5 years of age.

Contact: Functional & Applied Biomechanics, (301) 412-5989, ccrmdfab@mail.nih.gov and Diane L Damiano, Ph.D., (301) 451-7544, damianod@cc.nih.gov

North/Northeastern States (ME,VT, NH, MA, RI, CT, NJ, NY, PA, OH, IN, MI)
Map of the United States with the Northern / Northeastern States highlighted
1) Immersive Virtual Reality for Visuo Motor Skill Assessment in Children with Hemiplegia

Study Description

The purpose of this study is to evaluate low-cost head mounted display virtual reality as a realistic assessment tool for visual-motor integration deficits in children with hemiplegia. The long-term goals of our research program are to: 1) Inform clinical decision-making practices by providing families and clinicians with precise, accurate information about children's abilities; and 2) Generate new knowledge about visual-motor integration impairments to enhance the effectiveness of both virtual and conventional rehabilitation interventions.

https://clinicaltrials.gov/ct2/show/NCT04612049

Eligibility:

  • Children 7 - 16 years old with hemiplegia (due to CP or stroke)
  • Gross Motor Function Classification System (GMFCS) Levels I-III
  • Manual Ability Classification System (MACS) Levels I-II
  • Ability to read and write English
  • Sufficient hearing, vision and cognition to respond to auditory and visual cues.

2) Home Based Tele-Exercise for People with Chronic Neurological Impairments

Study Description

This study aims to examine how effective seated Zoom exercise classes are for a person with CNI for addressing cardiovascular health, physical wellness and quality of life.  If these classes prove to be effective, online platforms could be a viable avenue for those with CNI to exercise and increase/maintain wellness without having to leave their homes. The entire process, including screening and consenting, will be done via Zoom and Redcap.

https://clinicaltrials.gov/ct2/show/NCT04564495

Eligibility:

  • Adults aged 18 - 75 with chronic (>6 months) neurological impairments
  • Participants who can provide a medical clearance to participate in the program and remain seated for at least an hour
  • Heart rate/BP considerations, per each participant's MD
  • Participants must be able to don/doff HR monitor without assistance, or have assistance if necessary
  • Participants must maintain their current exercise/physical activity routine during the course of the study
  • Clinically stable with no other neurological, medical or cognitive impairments
  • Reliable Internet connection and ability to use Zoom platform
  • Participants must speak and understand English
  • No contraindication/limitations to exercise
  • Currently exercising 2 days or less per week

Contacts: Kathleen Friel, PhD  914-368-3116  kaf3001@med.cornell.edu

3) The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy - Teachers College - Columbia University

Study Description

A recent systematic review found that therapeutic interventions that adopted the principles of motor learning with intensive training improved functional upper limb movement in children with unilateral CP.  The purpose of this study is to conduct a multi-center randomized control trial (RCT) to determine whether 90 hours of HABIT-ILE improves functional motor skills, activity and motivation in children with CP when dosed in a camp format at 6-hours/day, 5 days/week for three weeks and 6-hours/day, one day/week for 15 weeks.

https://clinicaltrials.gov/ct2/show/NCT03940989

Eligibility:

  • Children 5 - 17 years old with bilateral cerebral palsy
  • Need to live within commuting distance of Columbia University (NY, NY)
  • Gross Motor Function Classification System (GMFCS) levels II-IV
  • Able to get up from a chair with standby assist, sit on a mat table with upper extremity support, understand directions, and walk 10 steps with/without assistive device and standby assist
  • Ability to understand and speak english
  • Willing to restrict Botox/Dysport use for 3 months prior to each of the 4 full assessments
  • Willing to be randomized to either camp format

Contacts: Andrew Gordon, PhD  212-678-3326  ag275@tc.columbia.edu

4) Real World Testing of Brain-Computer Interface

Study Description

The goal of this project is to test a new augmentative and alternative communication brain computer interface (AAC-BCI) device comparing gel and dry electrode headgear used for communication while providing clinical care. Data on communication performance, user satisfaction, and perceptions of communication effectiveness are gathered over monthly visits along with the satisfaction and perceptions of communication effectiveness by the family support persons.

https://www.clinicaltrials.gov/ct2/show/NCT04026581

Eligibility:

  • Individuals 14 years and older with severe communication disabilities and minimal movement impairment
  • Natural speech does not meet daily communication needs requiring using a speech generating device
  • Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display

Contacts: Shannon Carney  412-489-5527  scarney@aacinstitute.org and Katya Hill, PhD  412-523-6424  khil@pitt.edu

South/Southeastern States (VA, WV, KY, DE, MD, TN, AL, MS, NC, SC, GA, FL)
Map of the United States with the Southern States highlighted in purple
1) Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders

Study Description

Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch gait, an abnormal way of walking. Knee crouch has many causes, so no single device or approach works best for everybody. This study's adjustable brace provides many types of walking assistance. Researchers will evaluate brace options to find the best solution for each participant, and whether one solution works best for the group.

Three forms of assistance will be provided at the knee joint including a passive-damper component, functional electrical stimulation (FES) to the quadriceps, and a motorized assist. One form will provide controllable resistance at the knee to strengthen muscles and promote knee extension after the resistance is removed. These will be compared to traditional bracing which typically improves crouch by blocking some or all motion at one or both joints. We hypothesize that all assistive configurations will improve gait alignment and performance compared to the non-assisted conditions. We further hypothesize that a best solution for each participant will exist, but may vary across subjects due to the heterogeneity of these movement disorders. 

https://www.clinicaltrials.gov/ct2/show/NCT01961557

Eligibility:

  • Children 5 - 17 years old with CP.
  • Healthy volunteers 5 - 17 years old.

Contacts: Jesse H Matsubara(301) 451-7530  jesse.matsubara@nih.gov  and Thomas C Bulea, M.D.(301) 451-7533 buleatc@mail.nih.gov

2) Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study in Adults

Study Description

The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities.The secondary aim is to compare the results to a previous M2M study that groups participants based on disability type rather than functional mobility. The third aim is to consider adherence (defined as attendance to the 12-week program) as a variable that could affect results.

https://clinicaltrials.gov/ct2/show/NCT03797378

Eligibility:

  • Adults 18 to 70 years old with a primary diagnosis of head injury, stroke, multiple sclerosis, spinal cord injury, spina bifida, Parkinson disease, cerebral palsy by a physician
  • Able to use upper limbs and/or lower limbs to exercise and follow instructions
  • Physician clearance to participate
  • Willing to participate in an exercise program three times per week
  • Conversant in and reads English

Contacts: Hui-Ju Young, PhD  205-403-5521  hjyoung@uab.edu

3) Short-Burst Interval Treadmill Training Cerebral Palsy (Louisiana SITE)

Study Description

Ambulatory children with cerebral palsy (CP) walk predominately in low intensity stride rates with little variability, thus limiting walking activity and ability to participate in daily life. In contrast, typically developing (TD) children engage in short bursts of intense walking activity interspersed with varying intervals of low intensity walking within daily life. The proposed research will be the first step in a continuum of research that is expected to direct locomotor training protocols and rehab strategies across pediatric disabilities and positively affect walking performance and mobility for children with CP.

https://clinicaltrials.gov/ct2/show/NCT04026295

Eligibility:

  • Children 6 - 10 years old with bilateral spastic cerebral palsy 
  • Gross Motor Function Classification Levels II & III

Contacts: Noelle Moreau, PhD, PT  504-568-4291  NMorea@lsuhsc.edu, 

4) I-C-Fun In Children with Cerebral Palsy

Study Description

Our previous study proved that when paired with strength training, remote limb ischemic conditioning (RLIC) improves muscle strength and activation in healthy young adults and motor learning in healthy older adults. Our current work is to determine if RLIC enhances muscle power, dynamic balance, and walking performance in children with CP. This study will allow us to design and execute randomized controlled trials in children with CP as well as other neurological conditions.

https://www.clinicaltrials.gov/ct2/show/NCT04598711

Eligibility:

  • Children 6 - 16 years old diagnosed with unilateral or diplegia cerebral palsy (CP)
  • Gross Motor Function Classification System (GMFCS) levels I-III

Contacts: Swati M Surkar  252-744-6244  surkars19@ecu.edu  and  John Willson  252-744-6241  willsonj@ecu.edu

Central/Northern Central States (WI, MN, IA, IL, MO, AR, LA, TX, OK, KS, NE, SD, ND)
Map of the United States with Central and North Central States highlighted in pink
1) Perinatal Stroke: Brain Reorganization During Infancy

Study Description

This will be a multiple-visit observational study done to identify possible bioindicators of recovery and repair of motor corticospinal pathways which may be targeted by future interventions in infants with perinatal stroke. Researchers will use non-invasive brain stimulation, neuroimaging, and behavioral assessments to analyze associations between development patterns and potential diagnosis of CP.

https://www.clinicaltrials.gov/ct2/show/NCT05013736

Eligibility:

  • Infants with corrected gestational age between term age and 24 months of age at study enrollment
  • Radiologically-confirmed acute unilateral or bilateral brain lesions, including perinatal stroke, neonatal hemorrhagic or thrombotic stroke, involving the motor cortex and/or subcortical structures, and intracranial hemorrhage, involving the motor cortex and/or subcortical white matter, or periventricular leukomalacia
  • English-speaking parent/legal guardian (able to provide consent)

Contacts: Bernadette Gillick, PhD, MSPT  608-262-3079  bgillick@wisc.edu

2) COMET- C: Community Outreach Model of Education and Training on Communication - Focus Group 

Study Description

Researchers at the Shirley Ryan Ability Lab are seeking adults with communication difficulties over 21 with cerebral palsy, and other disabilities to share their experiences interacting with businesses/service providers during a two hour focus group. The goal of the research study is to learn about participants' experiences when they communicate with said providers.

For more information please call the Center for Aphasia research at 312-238-6163 or email Elissa Larkin, elarkin@sralab.org.

3) Stepping to understand lower limb impairments in bilateral cerebral palsy

Study Description

The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy (BCP) during stepping tasks. Individuals with BCP sustain a neonatal brain injury that leads to altered control to the lower limbs. This can make stepping up or down a curb or stair challenging and is especially important as performance in stair-climbing is associated with limitations to overall mobility and community participation in cerebral palsy. Consenting participants will be instructed to perform multiple step-ups and step-downs on a single raised platform. The parameters of the stepping task may change by adding or subtracting weights from the body.

https://clinicaltrials.gov/ct2/show/NCT04957277

Eligibility:

  • 5 - 19 year olds with the ability to independently step up, with or without assistive devices.
  • Typically developing with no diagnosed medical conditions that affect movement, OR with a diagnosis of bilateral cerebral palsy (including diplegia, tetraplegia, and quadriplegia) where the lower limbs are more affected than the upper limbs

Contacts: Theresa Moulton, PT, DPT, PhD  312-503-3342  theresa-moulton@northwestern.edu

4) robot based gait training therapy for pediatric population with cerebral palsy using the cpwalker

Study Description

This trial is being conducted to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments. Participants will engage in an 8-week training program, consisting of 2-3 sessions per week based on the level of gait impairment. Percentage range of motion (ROM), partial body weight support (PWBS), and gait velocity are the principal parameters under variation during training. Screening, baseline, and post-training testing sessions will be conducted.

https://clinicaltrials.gov/ct2/show/NCT03937700

Eligibility:

  • 11 - 21 year olds with a diagnosis of CP with spastic diplegia
  • Gross Motor Function Classification System score of 2-4
  • Maximum weight of 75kg
  • Height range of approximately 110cm to 170cm
  • Ability to understand and follow verbal cues
  • Lower limb measurements meet specifications of CPWalker
  • Cognition sufficient to communicate pain or discomfort and follow one step direction from the investigator

Contacts: Sara Prokup, DPT  312-238-1355  sprokup@ricres.org  and  Matt McGuire, DPT  312-238-3457  mmcguire@ricres.org

Western States (NM, CO, WY, MT, ID, UT, AZ, NV, OR, WA, CA)
Map of the United States with Western States highlighted in dark green
1) The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy - Shriners Hospital for Children - Portland, Oregon

Study Description

A recent systematic review found that therapeutic interventions that adopted the principles of motor learning with intensive training improved functional upper limb movement in children with unilateral CP.  The purpose of this study is to conduct a multi-center randomized control trial (RCT) to determine whether 90 hours of HABIT-ILE improves functional motor skills, activity and motivation in children with CP when dosed in a camp format at 6-hours/day, 5 days/week for three weeks and 6-hours/day, one day/week for 15 weeks.

https://clinicaltrials.gov/ct2/show/NCT03940989

Eligibility:

  • Children 5 - 17 years old with bilateral cerebral palsy
  • Need to live within commuting distance of Shriners Hospitals for Children-Portland (Portland, OR)
  • Gross Motor Function Classification System (GMFCS) levels II-IV
  • Able to get up from a chair with standby assist, sit on a mat table with upper extremity support, understand directions, and walk 10 steps with/without assistive device and standby assist
  • Ability to understand and speak english
  • Willing to restrict Botox/Dysport use for 3 months prior to each of the 4 full assessments
  • Willing to be randomized to either camp format

Contacts:  Susan Sienko, PhD 503-221-3481 ssienko@shrinenet.org and 

2) Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children with Cerebral Palsy (START-PLAY-CP) - Los Angelas,  Seattle and Omaha

Study Description

Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments. The purpose of the proposed project is to compare the efficacy of these two fully developed physical therapy interventions in 8-24 months olds with or at high risk of having Cerebral Palsy (CP).

https://clinicaltrials.gov/ct2/show/NCT04230278 or https://start-play.unl.edu/SIT-PT/what-is-sit-pt/

Eligibility:

  • Dx or clinical signs of cerebral palsy (CP) previously described
  • Between 8-24 months of age (corrected for prematurity as applicable) at study entry
  • Able to prop sit for 3 seconds, maintain the head at least to the level of neutral alignment with the trunk supported at the axilla, exhibit some spontaneous movement of the arms and visually focus on a toy or person's face for at least 3 seconds in any position.
  • Gross motor delay with a Bayley IV gross motor subscale score less than 5.5 (1.5 standard deviation below mean)

Contacts: Stacey Dusing  323-442-1022  stacey.dusing@pt.usc.edu, Sandra Willett, PhD, PT  402-559-6415  swillett@unmc.edu,  Lin-Ya Hsu, PhD  206-669-2492  linyahsu@uw.edu

3) Short-Burst Interval Treadmill Training Cerebral Palsy - Seattle Site

Study Description

Ambulatory children with cerebral palsy (CP) walk predominately in low intensity stride rates with little variability, thus limiting walking activity and ability to participate in daily life. In contrast, typically developing (TD) children engage in short bursts of intense walking activity interspersed with varying intervals of low intensity walking within daily life. The proposed research will be the first step in a continuum of research that is expected to direct locomotor training protocols and rehab strategies across pediatric disabilities and positively affect walking performance and mobility for children with CP.

https://clinicaltrials.gov/ct2/show/NCT04026295

Eligibility:

  • Children 6 - 10 years old with bilateral spastic cerebral palsy 
  • Gross Motor Function Classification Levels II & III

Contacts: Kristie F Bjornson, PhD, PT  206-884-2066  kristie.bjornson@seattlechildrens.org, and Neil Panlasigui, BS  206-884-2066  neil.panslasigui@seattlechildrens.org