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

Location: Virtual

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

2) Promoting Upright Mobility in Infants with CP Using a Robotic "BabyG" Unweighting System 
 

Study Description

The purpose of the study is to evaluate the effects of 12 weeks of mobility training while in a computer-controlled (robotic) unweighting system (BabyG) on motor development rate in infants diagnosed with or at high risk for cerebral palsy (CP) who are less than 18 months old at enrollment compared to a 12-week period when they are not participating in training.The protocol entails 12 weeks of BabyG training and 12 weeks without. Training will be 90 minutes per week: either two 45-minute sessions or three 30-minute sessions. All participants will undergo tests during the 24 weeks.

https://clinicaltrials.gov/study/NCT06593886

Eligibility:  

• 5 months to 18 months (adjusted for prematurity for those 37 weeks or less)
• Diagnosis of CP or high risk of CP
• Ability to push up on extended arms in prone for at least 10 seconds or demonstrates an interest in moving from one place to another by rolling
• Scooting or other means. 

Location:  NIH, Bethesda, MD
Contact: Mark N Dhason, (301) 451-7529, mark.dhason@nih.gov
 

3) 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.

Location: NIH, Bethesda, MD

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

4) Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children with Movement Disorders
 

Study Description:

The purpose of the study is to learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder. This study takes place over 1 year and is split into three 12-week phases. During 1 phase, participants will continue with their standard therapy. In phase 2, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches. In phase 3, participants take the exoskeleton home where they walk in the device at least 1 hour per day, 5 days per week, for 12 weeks. Walking ability will be retested after each phase.

https://clinicaltrials.gov/study/NCT05726591

Eligibility:

• 3 years – 17 years

• Diagnosis of CP

• Able to walk 10 feet with or without assistance

Location: NIH, Bethesda, MD
Contact: Mayra J Medrano, 301-451-7529, mayra.medrano@nih.gov, Thomas C Bulea, M.D, 301-451-7533, buleatc@mail.nih.gov

5) Effectiveness of Robotic Gait Training and Physical Therapy for Children and Youth with Cerebral Palsy
 

Study Description:

The purpose of the study is to compare: 1) a walking training program with the Lokomat® robotic device (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular maintenance therapy condition (CONT) for ambulatory children and youth with CP. The three intervention programs will consist of sixteen 50-minute sessions given twice weekly over 8 to 10 weeks. 

https://clinicaltrials.gov/study/NCT02391324

Eligibility: 

• 5 years to 18 years
• Ambulatory CP
• GMFCS II or III

Locations: Shirley Ryan Ability Lab, Chicago, IL; University of Alberta, Alberta, Canada; Holland Bloorview, Toronto, Canada

Contact: Lesley Wiart, PhD, 780-492-2971, lwiart@ualberta.ca   

6) 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

1) Locomotor Learning in Infants at High Risk for Cerebral Palsy

Study Description:
The purpose of the study is to characterize the evolution of locomotor learning - early spontaneous movement, prone locomotion (crawling), and upright locomotion (walking) - over the first 18 months of life in infants at high risk for cerebral palsy (CP). This study is over 18 months in 3 phases. The first phase will be the monthly observation of early spontaneous leg movements from 1-4 months of age. The prone locomotor intervention (crawling therapy) phase occurs from 5-9 months of post-term age, or end earlier if the child achieves the ability to crawl six feet. Treatment is 3 times per week for 15-30 minutes. The upright locomotor intervention (walking therapy) will be 9-18 months of age, or begin earlier and end early depending on the baby. Treatment will be 3 times per week for 30 minutes. Infants will receive dynamic weight support (DWS) for the duration of the 30-minute therapy session.
 

https://www.clinicaltrials.gov/study/NCT04561232

Eligibility:

• Less than 6 weeks
• Early Developmental Brain Injury associated with high risk for cerebral palsy including periventricular leukomalacia, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, hydrocephalus, stroke, neonatal seizures, or intracranial cystic lesion.

Location: Children’s Hospital of Philadelphia, Philadelphia, PA
Contact: Laura Prosser PhD, 215-590-2495, prosserl@chop.edu

2) NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

Study Description:

The purpose of this study is to investigate if a person with weakness or paralysis in one or both arms, can use the NuroSleeve combined powered arm brace (orthosis) and muscle stimulation system to help restore movement in one arm sufficient to perform daily activities. Participants will receive a customized NuroSleeve and undergo 8 weeks of occupational therapy using the NuroSleeve (135 minutes per week for 8 weeks: this can be done as 45 minutes three times per week, 68 minute sessions twice per week, or one 135 minute once per week).

https://clinicaltrials.gov/ct2/show/NCT04798378

Eligibility:

• 4 years and up
• Arm Weakness
• No joint contracture, spasticity or other limitations to range of motion in the affected lower limb(s) precluding the operation of a wearable, powered orthotic device on the arm

Location: Thomas Jefferson University, Philadelphia, PA
Contact: Erica Jones, 215-503-4042, CenterNR@jefferson.edu 

2) A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia

Study Description:

The purpose of this study is to assess the feasibility and utility of 2 types of play-based training programs co-delivered by researchers and caregivers within home/community settings to promote arm function among 3-to-8-year-old children with hemiplegia. Two investigators will assess the feasibility of implementation and acceptance/satisfaction associated with a researcher-caregiver co-delivered community-based training program involving either joystick-operated powered ride-on toys (SPEED training) or creative upper extremity training (CRAFT training).
The investigators will also compare the effects of these 2 types of training programs on children's arm motor function and spontaneous use of their affected arm during daily activities.

https://clinicaltrials.gov/study/NCT06579027

Eligibility:

• 3 years to 8 years
• Diagnosis of hemiplegia or clear asymmetry in upper extremity strength and control
• Can maintain sitting for at least 15 minutes.

Location:  University of Connecticut, Storrs, CT
Contact: Sudha M Srinivasan, PhD, 860-486-6192, sudha.srinivasan@uconn.edu

4) Whole Body Vibration and Serial Casting for Children with CP 

Study Description:

The purpose it to study if serial casting in combination with Whole Body Vibration results in more rapid clinical change therefore reducing the need for prolonged intervention. This is a randomized trial comparing serial casting only; serial casting plus exercise; and serial casting, exercise and whole body vibration on ankle range of motion.

https://clinicaltrials.gov/study/NCT06693388

Eligibility: 

• 3 years to 17 years
• GMFCS levels I-III

• can stand with upper extremity support or less 

Location:  Nationwide Children's Hospital, Columbus, Ohio
Contact: Ben Reader, DPT, 614-722-8374
ben.reader@nationwidechildrens.org

5) 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).

https://classic.clinicaltrials.gov/ct2/show/NCT04897347

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

Location: Columbia University, NYNY

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

Location: Kansas City, MO

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) Acceptability and Efficacy of GO MOVE

Study Description:
The purpose of this study is to learn about the acceptability and efficacy of Go Move, a mobile website developed to assist youth with unilateral cerebral palsy and their caregivers with setting goals and selecting exercises and activities to meet the goals. Participants will set up and participate in a goal-driven home program using the Go Move mobile website. Participants will spend 1 hour and 15 minutes per week for 6 weeks working on their home program and will complete pre-intervention and post-intervention assessments.

https://clinicaltrials.gov/study/NCT06048419

Eligibility:

• 3 years – 17 years
• Unilateral CP
• GMFCS levels 1 or 2
• MACS levels 1-3 
• Age 3-17 years old
• Ability to follow directions and complete the assessment protocol
• Ability to access the GO MOVE webpage on a personal device

Location: Scottish Rite Hospital For Children, Frisco, TX
Contact: Angela Shierk, PhD, 469-412-7172 ext 1045, angela.shierk@tsrh.org or
Heather Roberts, PhD, 214-794-8117, hroberts3@twu.edu

4) Robot Based Gait Training Therapy for Pediatric Population with Cerebral Palsy Using the CPWalker
 

Study Description:

The Purpose of this study is to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy. Participants will Participate in 16-24 gait training sessions in the CPWalker over the course of 8 weeks with each session lasting up to 2 hours.

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

Eligibility:

• 11 years to 21 years 
• Bilateral CP
• GMFCS II-IV
• Maximum weight of 75kg
• Height range of approximately 110cm to 170cm
• Able to follow instructions and communicate pain or discomfort.

Location: Shirley Ryan Ability Lab, Chicago, IL
Contact: Sara Prokup, DPT, 312-238-1355, sprokup@ricres.org, Matt McGuire, DPT, 312-238-3457, mmcguire@ricres.org 

5) Robotic Exoskeleton Gait Training in Adolescents with Cerebral Palsy

Study Description:

The Purpose of this study is to take a fresh new approach on how robotic exoskeletons can be used in a therapeutic setting. As opposed to using them as a compensation tool, we are proposing to use them to perturb the legs to drive beneficial neuroplasticity in the key brain areas that govern the leg motor actions.Participants will undergo baseline mobility/brain imaging/cognitive testing. After completing the baseline tests, the participants with CP will undergo the therapeutic gait training using either traditional physical therapy or utilizing a robotic exoskeleton consisting of 24, 60 minute treatment sessions that will be performed 3 times-a-week for an 8-week period. After completing all of the therapeutic gait training sessions, the participants will repeat the same assessments that were completed at baseline. The two groups will be compared based on the assessments for therapeutic outcomes.

https://www.clinicaltrials.gov/study/NCT05158218

Eligibility:

• 14 years to 30 years
• Diagnosis of CP

Location: Boys Town National Research Hospital, Boys Town, NE
Contact: Max J Kurz, PhD, 531-355-8916, max.kurz@boystown.org