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95 Cerebral Palsy Trials
Power is an online platform that helps thousands of Cerebral Palsy patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Children with cerebral palsy have increased muscle tone which often results in decreased active and passive movement at the ankle. While many management strategies exist (including passive stretching, WBV, serial casting, Botox, and surgical tendon lengthening), the utilization of WBV in combination with active exercises and serial casting has not been previously explored. Serial casting is the repeated application of a fiberglass cast (such as that applied to manage stable fractures) on a scheduled (usually weekly basis) to gradually increase the range of motion at a specific joint. It is theorized that combining previously established standard of care practices may result in more rapid clinical change, and hence reduce the need for prolonged intervention; ultimately reducing healthcare costs.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:3 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Rhizotomy, Orthopedic Interventions, Cancer, Others
Must Not Be Taking:Botox
45 Participants Needed
Tele-Video CIMT for Cerebral Palsy
Columbus, OhioThe CHAMP-T2 study is a pilot test of the efficacy of constraint induced movement therapy (CIMT) when delivered by tele-video in the child's home or home-like environment. This study will examine the pre-, post-intervention function a hemiparetic limb in children who have hemiplegic cerebral palsy. The purpose is to provide an effect size estimate that will inform the design of a future study that will compare tele-delivered CIMT with usual and customary care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 10
Sex:All
Key Eligibility Criteria
Disqualifiers:Previous High Dose CIMT, Surgery, Medically Unstable, Behaviorally Impaired, Others
Must Not Be Taking:Botulinum Toxin
10 Participants Needed
Valbenazine for Cerebral Palsy
Columbus, OhioThis trial is testing valbenazine, a medication that may help reduce involuntary movements. It targets children and adults with cerebral palsy who have these movements. The drug works by balancing chemicals in the brain to control movement better. Valbenazine has a longer duration of action and improved side effect profile compared to other similar medications.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Dyskinesia From Other Conditions, Suicidal Behavior, Substance Abuse, Others
80 Participants Needed
Aquatic Therapy for Cerebral Palsy
Columbus, OhioThe purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention for children ages 3-9 with neuromotor deficits such as cerebral palsy. The intervention takes place in a warm water therapy pool, twice a week for ten weeks and targets swim safety skills, upper extremity function and self care participation and performance.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:3 - 9
Sex:All
Key Eligibility Criteria
Disqualifiers:Compromised Airway, Uncontrolled Seizures
36 Participants Needed
Radiosurgery for Spasticity
Columbus, OhioA scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Inability To Lie Supine, Others
22 Participants Needed
Intensive Infant Rehabilitation for Perinatal Stroke
Columbus, OhioThis trial is testing a new therapy program called I-ACQUIRE for infants who have had a stroke. The program involves intensive sessions with therapists to help improve movement and strength. The study will compare two different amounts of therapy to usual treatments to see which works best.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:8 - 36
Sex:All
216 Participants Needed
Let's Move Program for Infants with Cerebral Palsy
Cincinnati, OhioThe intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:3 - 8
Sex:All
Key Eligibility Criteria
Disqualifiers:Oxygen Dependence, Significant Visual Deficits, Remote Location, Others
20 Participants Needed
Shockwave Therapy for Erectile Dysfunction
Cleveland, OhioThe purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Cardiac Disease, Others
Must Not Be Taking:SSRI, Psychotropic
186 Participants Needed
iovera° System for Muscle Spasms
Pittsburgh, PennsylvaniaThis multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Stroke, Brain Injury, Spinal Injury, Others
Must Be Taking:Oral Baclofen
132 Participants Needed
Nasopharyngeal Airway for Sleep Apnea
Ann Arbor, MichiganThis research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:3 - 23
Sex:All
40 Participants Needed
Wellness Programs for Disabilities
Pittsburgh, PennsylvaniaPeople 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." Studies have shown that the Triple Aim can be achieved through programs that facilitate community integration; however the U.S. healthcare system lacks a paradigm of care for individuals with disabilities that promotes community integration. 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.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:
Age:7+
Sex:All
130 Participants Needed
MHealth System for Chronic Health Conditions
Pittsburgh, PennsylvaniaThis 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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12+
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Intellectual Disability, Psychiatric Illness, Others
160 Participants Needed
Cognitive Behavioral Therapy for Chronic Pelvic Pain Syndrome
Ann Arbor, MichiganThis trial tests a brief cognitive behavioral therapy to help people with chronic pelvic pain. It aims to teach skills for managing pain and symptoms with minimal clinician help. The study focuses on adults with conditions like interstitial cystitis and chronic prostatitis, which are hard to treat with current methods. The therapy works by changing how patients think about and cope with their pain. Cognitive Behavioral Therapy (CBT) has been shown to be an effective treatment for chronic pain in numerous studies.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Urethral Stricture, Pelvic Malignancy, Major Psychiatric Disorder, Others
240 Participants Needed
Wheelchair Skills Training for Mobility Impairments
Grand Rapids, MichiganThis trial tests a training program called Skills on Wheels, which helps children with physical disabilities learn to use manual wheelchairs on their own. The goal is to make them more confident and safe in using their wheelchairs, and to improve their social skills and participation in activities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 17
Sex:All
4 Participants Needed
Wheelchair Skills Training for Cerebral Palsy
Grand Rapids, MichiganFor children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Cannot Sit For 60 Minutes, Own Power Wheelchair, Others
16 Participants Needed
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal limitations. Current literature indicates pain as a common experience for children with CP but has been understudied in this population. Moreover, inadequate post-operative pain control can result in negative physiologic and psychological complications and lead to poor surgical outcomes. Currently, perioperative pain management following orthopaedic procedures in pediatric patients follows traditional protocols that rely on the administration of opioid medications despite their known adverse side effects including nausea, vomiting, itching, constipation, urinary retention, confusion, and respiratory depression.
Epidural anesthesia is a key modality in traditional pain management for pediatric patients with CP given its proven efficacy in decreasing pain and managing spasticity. Yet, administering epidural anesthesia in this patient population poses several risks including damage to preexisting intrathecal baclofen pumps, iatrogenic infection, and technically demanding insertion given high rates of concomitant neuromuscular scoliosis. Alternatively, multimodal analgesic injections theoretically offer an efficacious adjunct to traditional pain management protocols with a lower risk profile. Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo showed decreased pain scores and narcotic consumption postoperatively in this patient population. Based on these promising results, the objective of this randomized control trial is to evaluate the efficacy of a multimodal surgical site injection compared to epidural anesthesia for postoperative pain control following operative management of hip dysplasia in pediatric patients with CP.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:< 18
Sex:All
Key Eligibility Criteria
Disqualifiers:Allergy To Injection, Epidural Reaction
Must Not Be Taking:Opioids
90 Participants Needed
Load Modulation for Cerebral Palsy
Chicago, IllinoisThe purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:5 - 19
Sex:All
30 Participants Needed
Robotic Gait Training + Physical Therapy for Cerebral Palsy
Chicago, IllinoisRobot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to support its effectiveness compared to best practice physical therapy is lacking. This research consists of a randomized controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The goal of the RCT 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 (aged 5- 18 years). The three intervention programs will consist of sixteen 50-minute sessions given twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four groups with respect to walking-related motor skills as measured by the Gross Motor Function Measure. The secondary objectives are to compare each intervention's impact on walking abilities, individualized goals, fitness, balance, physical activity levels, child's belief in ability to do physical activity, participation and quality of life. The investigators will also evaluate the extent of carryover or progress 3 months after the intervention. The qualitative part of the study will consist of interviews of children and parents after they have finished the study intervention. The information from the interviews will assist us with interpretation of the outcome results (areas of impact and amount of change) from the RCT. In particular, the interviews will 1) provide insight into their experiences with the trial interventions, 2) identify the mobility-related outcomes that are important to families and the factors that influence their preferences, and 3) explain the family values, experiences and contextual factors that influenced participation in the study. This research will provide information needed to allow clinicians and families to make informed choices about Lokomat therapy and physical therapy options in relation to their child's functional goals and abilities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 18
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Spasticity, Hip Instability, Others
Must Not Be Taking:Botulinum Toxin
160 Participants Needed
Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness
Mississauga, OntarioThe research is being done to compare two methods of creating AFOs: 1. The traditional method, which involves manually creating a mold from a plaster cast of the client's limb. This is time-consuming and labor-intensive; and 2. The newer method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. We want to know whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:8+
Sex:All
50 Participants Needed
Metformin for Cerebral Palsy
Toronto, OntarioThis trial is testing a diabetes medication in children with cerebral palsy to see if it can help them move and think better by improving how their bodies use energy.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:5 - 18
Sex:All
3 Participants Needed
Functional Electrical Stimulation for Cerebral Palsy
Toronto, OntarioPhysical rehabilitation interventions that promote activity-dependent neuroplasticity are desired for children with CP as this will result in improved motor skill and function. In adult neurological populations, such as stroke and spinal cord injury, FES is a recommended, evidence-based intervention that addresses motor and sensory impairments and promotes neuroplasticity. The evidence base supporting the safety, feasibility and efficacy of FES for youth with CP is rapidly growing, yet FES is not commonly used in Canadian pediatric rehabilitation. Through interviews with Canadian pediatric physical and occupational therapists, we identified numerous barriers to FES implementation, including a lack of knowledge and training in FES, difficulty accessing FES equipment, and a perceived lack of time to deliver FES within a treatment session. To address these barriers, we have developed an implementation intervention for FES that consists of an online course and toolkit for physical and occupational therapists. As a next step, we will evaluate the effects of the implementation intervention on pediatric therapists' knowledge, confidence and use of FES.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:All
Sex:All
18 Participants Needed
Virtual Intervention for Infants with Cerebral Palsy
Toronto, OntarioThis will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, the investigators will enhance understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. The results of this study will help inform the design of a larger, multi-center randomized controlled trial.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:4 - 5
Sex:All
150 Participants Needed
Robotic Walking Device for Child Movement Disorders
Bethesda, MarylandThis trial tests a robotic exoskeleton that helps children with walking difficulties due to conditions like cerebral palsy or spinal cord injury. The device can either assist or challenge their walking to strengthen muscles and improve movement. Children will use the exoskeleton in different settings to see if it improves their ability to walk. Robotic exoskeletons have been increasingly used in pediatric rehabilitation to assist children with cerebral palsy in improving their walking abilities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:3 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Seizures, Pregnancy, Others
44 Participants Needed
Knee-Ankle-Foot Brace for Cerebral Palsy
Bethesda, MarylandBackground:
- 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.
Objective:
- To evaluate a new brace to improve crouch gait in children with CP.
Eligibility:
* Children 5 17 years old with CP.
* Healthy volunteers 5 17 years old.
Design:
* All participants will be screened with medical history and physical exam.
* Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG described below.
* Participants with CP will have 6 visits.
* Visit 1:
\<TAB\>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow their movement.
\<TAB\>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle activity.
\<TAB\>3. Participants knee movement will be tested.
\<TAB\>4. Participants will walk 50 meters.
\<TAB\>5. Participants legs will be cast to make custom braces.
* Visit 2:
* Participants will wear their new braces and have them adjusted.
* Steps 1 3 will be repeated.
* EEG: Small metal discs will be placed on the participants scalp. They record brain waves.
* Participants will have electrical stimulation of their knees and practice extending them.
* Participants will take several walks with the braces in different settings.
* Visits 3 5: participants will repeat the walking and some other steps from visit 2.
* Visit 6 will repeat visit 2.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 100
Sex:All
Key Eligibility Criteria
Disqualifiers:Seizure History, Pregnancy, Others
85 Participants Needed
BabyG Harness for Cerebral Palsy
Bethesda, MarylandBabyG is a soft harness attached to a robotic system mounted overhead. While wearing the harness, the infant is free to move around a 10-by-10-foot play area with a padded floor. The harness helps support the infant s weight; it also slows any falls and catches the body before it hits the floor. BabyG can be adjusted to support 5% to 50% of the infant s weight.
Participants will be in the study for 24 weeks, including 12 weeks with 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 such as:
A test to measure an infant s ability to perform tasks such as rolling, sitting, crawling, and walking.
A test to assess nerve function, movements, reflexes, posture, and muscle tone.
A test of brain activity while moving. The infant will be fitted with a snug cap with 64 electrodes. Then the infant will be placed in the BabyG harness and encouraged to take steps on a motorized treadmill. Their movements will be filmed.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:5 - 18
Sex:All
Key Eligibility Criteria
Disqualifiers:Orthopedic, Neuromuscular, Cardiovascular, Others
Must Not Be Taking:Baclofen
60 Participants Needed
Focused Ultrasound Pallidotomy for Cerebral Palsy
Washington, District of ColumbiaThe primary objective of the proposed study is to evaluate the safety of ExAblate Transcranial MRgFUS as a tool for creating bilateral or unilateral lesions in the globus pallidus (GPi) in patients with treatment-refractory secondary dystonia due to dyskinetic cerebral palsy
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 22
Sex:All
Key Eligibility Criteria
Disqualifiers:Primary Dystonia, Severe Spasticity, Others
Must Be Taking:Anti-dystonic Medications
10 Participants Needed
Cognitive Behavioral Therapy for Chronic Pain in Cerebral Palsy
Baltimore, MarylandThe purpose of this study is to understand if cognitive behavioral therapy can feasibly be provided to groups of adults with cerebral palsy and chronic pain via virtual group therapy sessions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Prior CBT, Recent Trauma, Others
40 Participants Needed
Hyaluronidase for Muscle Spasms
Baltimore, MarylandThis trial tests if using a special enzyme can help people who have stiff arm muscles after a stroke. The enzyme works by reducing substances that cause muscle tightness, which may improve arm movement and strength. This new therapy aims to reduce muscle stiffness by breaking down certain substances in the muscles.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Parkinson's, ALS, MS, Others
Must Not Be Taking:Botulinum Toxin, Baclofen, Phenol, Others
56 Participants Needed
Specialized vs Standard Physical Therapy for Cerebral Palsy
Richmond, VirginiaThe purpose of the proposed project is to compare the efficacy of two fully developed physical therapy interventions in 8-24 months olds with or at high risk of having Cerebral Palsy (CP). 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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 24
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Visual Impairment, Uncontrolled Seizures, Others
150 Participants Needed
Early Developmental Intervention for Premature Babies
Richmond, VirginiaInfants born very preterm (≤28 weeks of gestation) are at high risk of having developmental disabilities including cerebral palsy, coordination impairments, attention deficit and learning disabilities. Impairment including reduced postural control, movement variability, visual motor skills, and motor learning are common during the first months of life and are associated with later developmental disabilities. However, infant born very preterm rarely receive evidence based therapeutic intervention in the first months of life when basic science and animal intervention studies suggest the greatest efficacy. Barriers to enrollment in services delay the onset of services and delivery models rarely support targeted preventative intervention or enhanced parent engagement during in the transition from the neonatal intensive care unit (NICU) to home.
Targeted intervention supporting postural control and motor learning in the NICU have resulted in short term motor gains. Interventions that enhance parent's ability to read their infant's cues and provide engagement opportunities improve maternal mental health and infant social and cognitive outcomes in the short-term. The purpose of this randomized clinical trial is to evaluate the efficacy of an intervention that combines evidence based motor intervention and parent engagement to enhance the parent's ability to provide daily motor and cognitive opportunities resulting in improved motor and cognitive outcomes.
Supporting Play Exploration and Development Intervention (SPEEDI) uses guided participation to empower parents in reading infant's behavioral cues, identifying ideal times for interaction, and enriching the environment and learning opportunities. Parents participate in 5 session in 3 weeks while learning principles of engagement, readiness for interaction, and to provide early motor and cognitive learning opportunities. Parents provide 20 minutes of motor and cognitive play based enrichment daily for 12 weeks with bi-weekly physical therapist support. The parent is empowered to determine the infant's current abilities and advance the activities to the "Just Right Challenge" throughout the 12 weeks, likely continuing after the intervention.
The efficacy of SPEEDI will be assessed during delivery at 2 time point; the transition from the NICU to home (around the infant's due date) and at 3-4 months of adjusted age (after the infants due date). Ninety infants will be randomly assigned to a Usual Care group, SPEEDI_Early, or SPEEDI_Later group. Group differences will be assessed in developmental outcomes on the motor and cognitive scales of the Bayley Scales for Infant and Toddler Development as well as the Early Problem Solving Indicator and Gross Motor Function Measure at the end of each intervention period, 12 and 24 months of age.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:< 6
Sex:All
85 Participants Needed
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Frequently Asked Questions
How much do Cerebral Palsy clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Cerebral Palsy clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Cerebral Palsy trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Cerebral Palsy is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Cerebral Palsy medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Cerebral Palsy clinical trials ?
Most recently, we added tDCS + CIMT for Cerebral Palsy, Electrical Stimulation for Cerebral Palsy and Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness to the Power online platform.