Clinical Trials by Geographic Location

1) Virtual study: Measuring everyday experience in infants at risk for cerebral palsy

Study Description:

The purpose of the study is to learn more about everyday activity in infants at risk for cerebral palsy. Caregivers will receive text messages 10 times throughout their day (8 days total) with a link to a quick survey about their child’s current activities. The survey will take about 1 minute to complete each time. 

Lab website

Eligibility:

Infants 5 months to 12 months with cerebral palsy, perinatal brain injury, or documentation of clinical assessments (General Movements Assessment, HINE) indicating high risk for CP

Contact: Kari Kretch, PT, DPT, PhD, 323-442-0191, kretch@usc.edu 

2) 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

3) 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

4) 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

5) 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

6) 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

7) 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

8) 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

9) TELEHEALTH VIRTUAL REALITY GAMING ON CARDIOMETABOLIC HEALTH AMONG YOUTH WITH CEREBRAL PALSY

Study Description

VR gaming delivered via telehealth may be an optimal method of promoting sustainable exercise behavior among large groups of youth. Home-based telehealth programs that incorporate 'virtual' behavioral coaching (tele-coaching) are a desirable approach for promoting non-supervised, exercise behavior among people with disabilities who do not have convenient access to community programs.

The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group. The secondary purpose is to understand behavioral mechanisms that explain participation in exergaming through semi-structured interviews with participants from both groups at post-intervention or dropout. 

https://clinicaltrials.gov/ct2/show/NCT05336227

Eligibility:

• Age 13-24
• medical diagnosis of cerebral palsy
• physician clearance to participate
• access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
• a caregiver to support the child

Contacts: Raven Young (205) 638-6445,   ravensamuel@uabmc.edu  and Byron Lai, PhD  (205) 638 - 9790 ext 8-9725, blai@uabmc.edu    
 

1) Understanding Treatments for Dysarthria

Study Description

Our research seeks to address this gap by (1) Comparing the effectiveness of 3 speech modification strategies and (2) Identifying acoustic and kinematic markers that predict which strategies will be optimal for individual children and adolescents.

Eligibility:

• Children and adolescents between the ages of 8 and 17
• Have a medical diagnosis of CP
• Have reduced speech intelligibility
• Are able to repeat short sentences (at least 2-3 words in length)
• Speak English as a primary language.
• Have no reported hearing loss
• Are within traveling distance of Boston, Massachusetts (Note: we will cover parking costs for families to park in a campus garage or handicap accessible lot. We cannot reimburse families for other travel costs or lodging.)

Contact: smilespeechlab@northeastern.edu or Dr. Kristen Allison, the principal investigator, at 617-373-3697 or k.allison@northeastern.edu.

2) Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children with Hemiplegic Cerebral Palsy
 

Study Description: To explore if modified, commercially available, joystick-operated, ride-on-cars can be used to promote bilateral arm function in children with hemiplegic Cerebral Palsy. Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. 
 

Eligibility:

• 3 years - 8 years
• Diagnosis of CP
• Unilateral/Hemiplegia;
• Have had no physical trauma (including surgery) in the past 6 months
• Live near or can travel to University of Connecticut, Storrs, CT

Contact: Sudha M Srinivasan, PhD, 860-486-6192, sudha.srinivasan@uconn.edu

3) 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.

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

4) Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Study Description

The purpose of this study is to test the efficacy of a motor learning-based postural and reaching control intervention delivered with the robotic Trunk-Support-Trainer (TruST) compared to the same motor learning-based intervention delivered with Static Trunk Support Equipment in children with cerebral palsy (CP) classified as III and IV with the Gross Motor Function Classification System (GMFCS).

Eligibility:

• Age 6-17 years
• Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia
• Gross Motor Function Classification Systems-Expanded & Review (GMFCS) levels III or IV
• Ability to sit 5s with trunk support between mid-ribs and pelvis
• Ability to follow simple instructions

Contacts: Karen Chin 212-678-3332, cpresearch@tc.columbia.edu

1) Examining the Effect of Eye Gaze Technology on Children With Cortical Visual Impairment

Study Description:

The goal of this study is to learn about eye gaze technology's use as an assessment and intervention of visual skills and the impact on occupational performance in children with cortical/cerebral visual impairment. The main questions the study aims to answer are:
•    Does the use of eye gaze technology with graded visual activities improve visual abilities:
•    Does an improvement in visual abilities improve occupational performance? - What are the factors that correlate with improved visual abilities?

https://clinicaltrials.gov/study/NCT06067607

Eligibility: 
•    Diagnosed with Cortical/Cerebral Visual Impairment by Physician
•    2-10 years of age
•    Parent or Caregiver available for interview

Contact:  Tammy Bruegger, OTD, 816-501-4342, Tammy.Bruegger@rockhurst.edu or Sunni Alford, OTD, 816-501-3269, sunni.alford@rockhurst.edu
 

2) 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

3) 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.

4) 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

5) 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