Orthopedics Clinical Research

Researchers at Nationwide Children’s Hospital and Ohio State University are seeking volunteers to participate in a pediatric physical therapy treatment study for children with gross motor delays to find out the most effective service delivery of rehabilitation.

Your child may be eligible for this study if you or your child meets the following criteria:

• Is between 2 and 8 years of age

• Diagnosis of motor delay or CP in GMFCS levels I- V

• Is able to participate in outpatient physical therapy and attend visits consistently

• Parent/Caregiver agrees to participate in long-term follow up

Your child will receive a total of 40 hours of physical therapy delivered in either 1 hour or 2 hour sessions depending on group assignment, along with 9 monthly physical therapy consultations and 4 assessments. All participants will be compensated for study participation. Parking will be covered for everyone.

For more information, please contact the ACHIEVE study team, let by Dr. Jill Heathcock, at 614-572-5446, or email ACHIEVE@osumc.edu.

Study ID: IRB16-00492

Researchers at Nationwide Children’s Hospital and Ohio State University are seeking volunteers to participate in a pediatric physical therapy treatment study for young children with significant gross motor delays to find out the most effective service delivery of rehabilitation for young children with significant motor delays. 

Your child may be eligible for this study if you or your child meets the following criteria:

• Is between 6 months-24 months of age

• Has persistent delays in motor skills, Is between 6 months-24 months of age

• Is able to participate in outpatient physical therapy and attend visits consistently

• Parent/Caregiver agrees to participate in long-term follow up

A total of 20 session and monthly home visits are provided, the frequency of sessions differs for participants based on the group assignment. All participants will be compensated for study participation. Parking will be covered for everyone.

For more information, please contact the ACHIEVE study team, let by Dr. Jill Heathcock, at 614-572-5446, or email DRIVE@osumc.edu.

Study ID: IRB15-01025

The APPLES Study: A Positive Parent-focused training for upper Limb Experience with Sensory-motor feedback

What is the purpose of this study?

The purpose of this study is to evaluate the effectiveness of a soft mitt constraint on a weaker hand and parent-directed interactions on arm function for young children with hemiplegic cerebral palsy (CP).

Infants and young toddlers in this study will use a non-invasive, soft mitt for Constraint Induced Movement Therapy (CIMT), a therapy that is well-tested in older children with CP, along with specific games and activities.

Image: APPLES Study constraint participant crawling in a session with Helen Carey, PT, DHSc, PCS

• Some of the participants in this study will have CP, while others will not have motor difficulties.

• The study team will test how well a soft mitt used on the more affected hand, along with therapeutic activities taught by physicial therapists (from Nationwide Children's Hospital and The Ohio State University) may help improve motor function for participants with CP.

• Children enrolled in this study that do not have CP will only participate in assessment visits and will not use the soft mitt.

Who can participate in this study?

Infants and toddlers between the ages of 9-27 months at the time of enrollment are eligible for this study, after signed parental consent has been completed.

• Ages 9 to 27 months at the start of the study

• Infants with cerebral palsy who have one side of their body stronger than the other

• Infants without cerebral palsy and no other motor difficulties to participate as controls

Caregivers must be willing to have their child with cerebral palsy wear a soft mitt for six (6) hours at a time and provide two (2) daily at-home sessions lasting 15 minutes each. After the mitt is taken off, caregivers will need to play with their child using two-handed toys as much as possible. Training and support by therapists, as well as materials for activities, will be provided to caregivers.

Caregivers must also be willing to come to Nationwide Children's Hospital for assessments, and transportation will be arranged as needed.

What will happen during this study?

There will be several visits during this study:

• Participants with cerebral palsy will have assessment and training visits.

• Participants without motor difficulties will only have assessment visits.

Assessment appointments will take between 45-60 minutes. During the appointment, research therapists will assess your child using standard movement assessments. A test called "Event-Related Potential (ERP)" will also be performed to measure natural brain electricity and record your infant's brain waves, using soft sensors placed on your child's head with a net, like a shower cap.

At the end of the first assessment visit, therapists will teach caregivers of participants with CP how to do activities at home using the mitts and supplies that we provide.

This study is randomized. This means that young infants and toddlers with CP will be randomly assigned to one of two groups:

• For children with CP, participants in both groups will receive the soft mitt constraint intervention.

• The difference between the two groups will be the timing of the start of these additional therapy services.

  • Your child will continue their regular therapy visits regardless of his/her group study assignment and regardless of his/her participation in the study.

  • In addition to providing materials to caregivers, we will also compensate you for your time.

Who can I contact for more information?

Please contact the APPLES study team, led by Nathalie Maitre, MD, PhD, by phone at (614) 935-6626 or by email at ApplesStudyGroup@NationwideChildrens.org.

Purpose of study:

When patients have spinal surgery, electrodes are placed in many places on the body to measure the nerve signals coming from the spinal cord. This is called motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). The anesthesia that is used to keep patients asleep during surgery can either be given through an intravenous catheter (IV) or inhaled through the breathing tube. Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At this hospital we typically use inhaled anesthesia and are able to successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than the other for measuring MEP and SSEP.

Who can participate: 

Patients with idiopathic scoliosis.

What will happen during the study: 

This study will consist of one visit and will last from the time you are taken back to the operating room until the day after your surgery. You will be taken to surgery and be put to sleep with gas that you inhale. After you are asleep you will have an IV started and a tube will be placed in your throat to help you breathe. You will receive anesthesia either through the IV or through the breathing tube, which will keep you asleep and without pain until the surgery is finished. Electrodes will be placed on your head, trunk, arms, and legs to measure MEP and SSEP. MEP and SSEP will be measured 4 times during the surgery. You will also have about 6 mls (½ tablespoon) of blood taken right after you go to sleep, at the end of your surgery, and the day after your surgery. The total amount of blood will not be more than about 20 mls or 1½ tablespoons. This blood will be taken from your IV so you will not have an extra needle stick.

Who to contact: 

Julie Rice, RN, BSN, CCRC 355-3142 Julie.Rice@nationwidechildrens.org.