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.
Currently there are 30 studies recruiting adults in the United States. Below we have highlighted a few diverse studies that have different areas of research focus. To search the full list of studies, visit clinicaltrials.gov . Each month we will highlight a few studies that may covering different topics of interest.
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.
1) Operant conditioning of the soleas stretch reflex
Individuals with CP face significant challenges due to spasticity that causes activity and participation restrictions with increase in secondary conditions. This is caused by injury to the upper motor neurons causing disruption to the neural circuitry responsible for maintaining motor tone. A novel intervention, OC of the H reflex has shown promising effects to reduce spasticity and improve motor function in people with stroke and spinal cord. Its many known benefits include easy administration, non-invasive technique, no side effects, and long-term retention. In the study, the investigators will attempt to decrease the increased muscle tone of individuals with CP.
- Age 18 and Above
- Diagnosis of spastic U/L Cerebral Palsy
- Gross Motor Function Classification System level I-III
- Stable medical background
- Current medication will remain unchanged for 3 months
- Provides informed consent
- Can walk at least 10 meters with or without assistive device
- Meets minimum study procedure requirements (elicitation of H-reflex).
2) Tele-Rehabilitation Home Exercise Program for Adults
This study aims to determine if a tele-rehabilitation home exercise program is feasible to promote adherence to a fitness and mobility exercise program in ambulatory adults with cerebral palsy (GMFCS I, II, III) aged 21- 60 year old, and second, to determine if a tele-health exercise program improves fitness and functional mobility for participants.
- Adults 21- 60 with spastic cerebral palsy (unilateral or bilateral)
- Gross Motor Function Classification System (GMFCS) Level I to III
- No orthopedic surgery in past year or botox in past 3 months
- Able to follow directions & attend for 20-30 minutes, stand independently up to 1 minutes with or without an assistive device, and walk independently up to 2 minutes with or without an assistive device
- Must have a laptop, tablet or smart phone to do the program
Contacts: Michael Spinner, MS, ACSM - CEP 212-305-9416 firstname.lastname@example.org and Lauren Winterbottom, MS, OTR/L 212-305-6722 email@example.com
3) Pain and Anatomical Correlation on MRI
The investigators hope to use MRI biomarkers to identify and characterize sensorimotor network disruption patterns associated with chronic pain and sensory deficits in CP. Investigators will use existing information in the medical record as well as subjective reports from interview, physical exam data, and anatomical and functional MRI data to non-invasively identify brain and spine injury correlates of pain and sensory deficits.
- Individuals with CP 8 years and older
Contacts: Collen Lenz, MS (443) 923-2706 CPpainStudy@kennedykrieger.org and Nicole Gorny, MS (443) 923-9272 CPpainStudy@kennedykrieger.org
4) MOVEMENT TO MUSIC
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.
- Between 18 to 70 years
- 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 firstname.lastname@example.org
5) Powered Wearable Orthoses
The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).
- Between 5 and 75 years old, inclusive.
- Either a healthy volunteer or a diagnosis of a neurologically-based walking disorder due to stroke, spinal cord injury, Parkinson's disease, or cerebral palsy.
- Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
- Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
- The ability to read and understand English.
- Able to walk at least 30 feet with or without a walking aid (GMFCS Level I-III for individuals with cerebral palsy)
Contacts: Zach Lerner, PhD 928-523-1787 Zachary.Lerner@nau.edu
6) Transcutaneous Stimulation for Neurological Populations
The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury.
- Individuals 10 to 70 years old with a neurologic condition
- Can walk 20 yards, with or without an assistive device, and have a stable medical condition
- Are capable of performing simple cued motor tasks and who can follow 2-3 step commands
- Have ability to attend up to 5 sessions per week physical therapy sessions and testing activities
- Have adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period.
- Can read and speak English
Contacts: Siddhi R Shrivastav, BPTh, MS 973-444-1940 email@example.com and Chet T Moritz, PhD 206-221-2842 firstname.lastname@example.org
7) Impact of Community Based Wellness Programs on the Triple Aim
People with disabilities experience a staggering incidence of secondary conditions that can result in death or negatively impact their health, participation in the community, and quality of life. Many of these chronic secondary conditions are preventable. The Institute for Healthcare Improvement has advocated for optimizing care through programs that simultaneously improve health and the patient experience of care, while reducing cost, called the "Triple Aim." In order to identify potential models of healthcare delivery for individuals with disabilities that are effective in achieving the Triple Aim, we will conduct a rigorous research project to evaluate the impact of two different models of care on the Triple Aim: 1) a community-based care management program delivered by a non-profit organization through waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with disabilities between ages 55-64.
- 7 years and older
- Individuals who are eligible for the Community Partners program
- Individuals who are eligible for the Community LIFE program between the age of 55-64
Contacts: Zara Ambadar, PhD 412-608-6118 email@example.com
8) Mobile Health Self-Management
This study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.
- 12 years or older with a diagnosis of a chronic and complex condition such as Spina Bifida, Spinal Cord Injury, Cerebral Palsy and Traumatic Brain Injury, etc.
- Live in a community setting (not within a residential facility that provides care to them)
- Pass all the functional screening tests which include basic usage of a smart phone, and impairment severity assessments
Contacts: Zara Ambadar, PhD 412-608-6118 firstname.lastname@example.org
9) Brain Computer Interface
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.
- 14 years and older with a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
- Natural speech does not meet daily communication needs requiring using a speech generating device
- Able to read a standard computer screen
- Able to follow instructions
- English as their native language
Contacts: Katya Hill, PhD 412-523-6424 email@example.com
10) Peripheral Modulation of Muscle Stiffness and Spasticity
This is a trial of human recombinant hyaluronidase injections in individuals with post-stroke upper limb muscle stiffness. The investigators will recruit 50 individuals, 25 males and 25 females, who will be randomized to receive either hyaluronidase plus saline or normal saline injections (first injection) in Phase 1 of the study over 5 visits. Then participants will cross over to Phase 2 to receive a second injection, where the treatment arm will receive the placebo and the placebo arm will receive the treatment. This design will ensure that all participants receive the drug treatment, which will facilitate recruitment.
- 18 years and older
- Ischemic or hemorrhagic stroke 6-120 months prior
- Moderately-severe muscle stiffness, score of 2-3
- Lack of full passive and active range of motion in at least 2/4 areas (shoulder, elbow, forearm, wrist) in the hemiparetic upper limb;
- Willingness to have MRI, complete all clinical assessments, and comply with study protocols;
- Ability to give informed consent and HIPPA certifications; and
Contacts: Maria Fernanda Pena Prieto, MD 410-955-1347 firstname.lastname@example.org and Matthew Bird, MA 410-955-1381 email@example.com
11) Sensorimotor Control During Postural Transitions in CP
The purpose of this study is to investigate whether a light electrical stimulation to leg muscles and joints can help people with Cerebral Palsy (CP) maintain balance during everyday tasks such as getting up from a chair and walking. Children and young adults with CP can have trouble with daily tasks such as standing up, sitting down on the chair and turning. The difficulty in maintaining balance sometimes lead to falls. This raises risk of disability in CP as children age into teens and adults. Current treatments are not very effective. In this study, children and young adults will be asked to stand up from a stool, walk in a straight line, turn, walk back and sit down on the stool. Participants will receive electrical stimulation at a very low intensity that cannot be felt to help increase their sensory perception. The investigators will evaluate treatment by testing balance, and other functional measures.
- Ages 8-24 with a diagnosis of CP and GMFCS level I-II
- Ability to stand up from a chair and start walking.
- Migration index of proximal hip (MIGR) < 40% femoral head covering in acetabulum
- At least 0° passive dorsiflexion range of motion (ROM)
- Sufficient visuoperceptual, cognitive and communication skills
- Seizure-free or well-controlled seizures
- No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability
- Ability to communicate pain or discomfort
- Ability to assent/consent or obtain parent/guardian consent
Contacts: Samuel CK Lee, PT, PhD 302-831-2450 firstname.lastname@example.org and Khushboo Verma, PT 302-831-7611 email@example.com
12) functional strength training and virtual reality for children with cp
*PLEASE NOTE THE ELIGIBILITY CRITERIA FOR THIS STUDY INCLUDES ADULTS UP TO AGE 30*
Virtual reality (VR) has shown to be effective to improve arm function in children with cerebral palsy (CP). Recently, functional strength training (FST) starts to show to improve arm function in patients with stroke but has not been extensively explored in children with CP. This pilot study is to examine the effect of FST and VR on improving arm function in children with CP as well as the neuroplasticity changes in the brain related to the level of improvement.
- Children with spastic CP between ages 5-18 years; adults with spastic CP between 19-30 years
- Have a Manual Ability Classification System (MACS) level I-III
- Able to sit with trunk supported
- Are able to reach forward for more than half of their arm length
- Are able to follow three-step commands
- Are able to see video screen (with or without corrected vision); and
- Their primary caregiver is willing to follow the desired intervention "dosing" and all evaluation measurements, including MRI.
Contacts: Yuping Chen, ScD, PT 404-413-1256 firstname.lastname@example.org
13) Reinforcing CP Robotic Training with Auditory Feedback
The purpose of this study is to create a platform to prolong the adaption obtained from the cable-actuated gait training and encourage the individuals with CP to provide self-care at home.
- Adults with cerebral palsy (18-65 years old)
- Ambulation of a distance of 100 feet with or without the use of assistive devices.
Contacts: Jiyeon Kang 716-645-6063 email@example.com
14) Cerebral Palsy and the Study of Brain Activity During Motor Tasks
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.
- Individuals at least 5 years of age who have cerebral palsy
- Healthy volunteers at least 5 years of age.
Contacts: Functional & Applied Biomechanics (301) 412-5989 firstname.lastname@example.org Diane L Damiano, PhD (301) 451-7544 email@example.com