Orthotic Device for Cerebral Palsy

Recruiting at 1 trial location

Overseen By Alice Chu, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Mild or severe hand disability, Botox, orthopaedic surgery, severe contractures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3 months

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new orthotic device designed to help children with cerebral palsy improve hand function. The device, called an Upper Extremity Orthotic, uses elbow movement to assist finger release, potentially enhancing the ability to grasp and release objects. The trial includes two groups: one using the orthotic device with occupational therapy and another using occupational therapy alone. Children aged 4-17 with cerebral palsy, who have moderate to severe hand disabilities and can actively move their elbow, might be suitable candidates. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could significantly improve hand function in children with cerebral palsy.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this orthotic device is safe for children with cerebral palsy?

Research has shown that arm and hand braces, like the one tested in this study, can help children with cerebral palsy. They may enhance the accuracy and control of arm and hand movements.

In past studies, these braces have been used safely with children who have cerebral palsy, and no major safety issues were reported. This indicates the brace is generally well-tolerated. While every treatment carries some risks, evidence so far suggests this brace is usually safe for children with cerebral palsy.

Consulting a healthcare professional about any concerns before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for cerebral palsy focus on physical therapy to improve motor skills. However, the upper extremity orthotic device is unique because it combines with occupational therapy to enhance arm and hand function. This orthotic device is designed to provide targeted support and alignment, potentially improving the effectiveness of therapy sessions. Researchers are excited about this treatment because it could offer a more integrated approach, combining physical support with therapeutic exercises to accelerate improvements in motor abilities. By addressing both physical and functional needs, this approach might lead to better outcomes for individuals with cerebral palsy.

What evidence suggests that this orthotic device is effective for improving upper extremity function in children with cerebral palsy?

Research shows that special devices called upper extremity exoskeletons can help children with cerebral palsy move their arms more accurately and improve control and performance. In this trial, one group of participants will receive an upper extremity orthotic device combined with occupational therapy, while another group will receive occupational therapy alone. These devices assist children in better controlling their limbs, especially when they have difficulty using their hands. The device works with the body's natural movements, like bending the elbow, to help fingers open and close. This makes it a promising tool for children with severe cerebral palsy. A small study using a similar device showed positive results when used with therapy focused on specific goals. This suggests that such a device could greatly help children who have trouble moving their hands. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for children aged 4-17 with cerebral palsy who have moderate to severe hand disabilities. They must be able to move their elbow, follow commands, and participate in setting goals and doing repetitive tasks.

Inclusion Criteria

I am aged 4-17 with cerebral palsy and have moderate to severe hand disability but can move my elbow and follow commands.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an upper extremity orthotic device and occupational therapy to improve upper extremity function

3 months

Regular visits for therapy sessions

Follow-up

Participants are monitored for changes in upper extremity function using assessments like Melbourne Assessment-2 and CHEQ

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Occupational Therapy
• Upper Extremity Orthotic

Trial Overview The study tests an upper extremity orthotic device (a type of dynamic splint or exoskeleton) combined with occupational therapy to improve arm function in children with limited hand use due to cerebral palsy.

How Is the Trial Designed?

Group I: Orthotic + Occupational Therapy Experimental Treatment 1 Intervention

Group II: Occupational Therapy alone Active Control 1 Intervention

Upper Extremity Orthotic is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Upper Extremity Orthotic Device for:

• Cerebral Palsy
• Upper Limb Dysfunction

Approved in United States as Upper Extremity Orthotic Device for:

• Cerebral Palsy
• Upper Limb Dysfunction

Approved in Canada as Upper Extremity Orthotic Device for:

• Cerebral Palsy
• Upper Limb Dysfunction

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

Methotrexate (Mtx) is the first-line treatment for juvenile idiopathic arthritis (JIA) due to its proven efficacy and safety, while biological agents like TNF inhibitors and tocilizumab have significantly improved outcomes for various JIA subtypes.

Biological treatments have a strong safety record in children, but require careful monitoring for rare adverse events, including serious infections and potential autoimmune complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Children with Juvenile Idiopathic Arthritis. Viswanathan, V., Murray, KJ.[2018]

A custom dynamic elbow brace significantly improved functional outcomes for a child with neonatal brachial plexus palsy by allowing controlled movement and resistance exercises, which helped activate muscles effectively.

The brace, when used alongside other therapeutic interventions, enhanced muscle strength, motor control, and overall mobility, demonstrating its effectiveness as a therapeutic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Implementation of a Custom Dynamic Elbow Brace for Children With Neonatal Brachial Plexus Palsy: A Case Report. Torrey, M.[2023]

Etanercept has shown general efficacy in treating juvenile idiopathic arthritis (JIA) based on one randomized controlled trial and six uncontrolled studies, but the overall evidence for other biologics like adalimumab and infliximab is limited or lacking.

There is insufficient long-term safety data for biologics used in JIA, which means clinicians should be cautious and consider the potential risks and benefits before prescribing these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologics for the treatment of juvenile idiopathic arthritis: a systematic review and critical analysis of the evidence. Gartlehner, G., Hansen, RA., Jonas, BL., et al.[2018]

Customized adjustable orthoses effectively reduce spastic contractures in patients, as demonstrated in a case where a head-injured patient showed improved wrist and ankle function, leading to increased use of her arm for daily activities.

These orthoses allow for gradual adjustments to promote range of motion without losing progress, and while they are costly, they may save on therapy time and reduce skin complications, making them a beneficial long-term solution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Customized adjustable orthoses: their use in spasticity. Collins, K., Oswald, P., Burger, G., et al.[2005]

The new dynamic hand-wrist orthosis was well-tolerated by chronic stroke patients, with five out of six participants wearing it for an average of 6 hours daily over six months without discomfort.

The orthosis significantly improved wrist extension, reducing contractures from -29° to -12°, and led to a decrease in the use of spasticity treatments like Botulinum Toxin for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerance and effectiveness of a new dynamic hand-wrist orthosis in chronic stroke patients. Andringa, AS., Van de Port, IG., Meijer, JW.[2016]

Dynamic splints significantly improved grip strength and dexterity in children with hemiplegic cerebral palsy, indicating that splint design can enhance hand function in this population.

Static splints reduced wrist muscle activation during grip tasks but led to increased shoulder muscle recruitment in children with cerebral palsy, suggesting a compensatory mechanism when using these splints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of wrist hand splints on grip, pinch, manual dexterity, and muscle activation in children with spastic hemiplegia: a preliminary study. Burtner, PA., Poole, JL., Torres, T., et al.[2022]

A systematic review of 16 studies on upper limb orthoses for children with cerebral palsy revealed a lack of clear reasons for prescription and no strong link between the intended outcomes and the effects observed.

The findings highlight the need for better documentation and classification of orthosis prescriptions, as well as the importance of using valid outcome measures to evaluate the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for prescription, and effectiveness of, upper limb orthotic intervention for children with cerebral palsy: a systematic review. Garbellini, S., Robert, Y., Randall, M., et al.[2019]

In a study of 260 patients with systemic-onset juvenile idiopathic arthritis (JIA), serious adverse events were more frequently reported in patients treated with canakinumab and tocilizumab, highlighting the need for careful monitoring of these biologics.

While overall tolerance to biologics was acceptable, specific risks such as infections were notably higher in patients treated with anakinra, and macrophage activation syndrome occurred more frequently in those receiving canakinumab and tocilizumab compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term surveillance of biologic therapies in systemic-onset juvenile idiopathic arthritis: data from the German BIKER registry. Klein, A., Klotsche, J., Hügle, B., et al.[2021]

Biologic agents, including TNF blockers and IL-targeting therapies, have significantly improved both short-term and early evidence suggests long-term outcomes for patients with juvenile idiopathic arthritis (JIA).

There are safety concerns regarding the long-term use of these biologics, particularly anti-TNF medications, which have been linked to an increased risk of malignancies after more than 2.5 years of treatment, highlighting the need for ongoing safety monitoring and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety profile of biologic therapies for juvenile idiopathic arthritis. Hashkes, PJ., Uziel, Y., Laxer, RM.[2021]

Ankle and foot orthoses may not always help children with cerebral palsy effectively, as inconsistent outcomes have been reported in research and clinical observations.

Improper fit and alignment of these orthoses, particularly when the subtalar joint is misaligned, can lead to compensatory movement patterns that hinder a child's progress and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of orthotic subtalar alignment for development and gait of children with cerebral palsy. Carmick, J.[2012]

A pilot study involving five children with cerebral palsy (ages 13 to 17) showed that a customized 3D-printed dynamic upper extremity orthosis (DUEO) combined with occupational therapy can improve upper extremity function in children with severe hand impairments.

Posttreatment assessments indicated that all participants had higher scores on at least one functional measure, with four achieving clinically meaningful improvements in their ability to use their hands, suggesting that this innovative orthosis can be an effective intervention for enhancing daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Use of a 3D-Printed Dynamic Upper Extremity Orthosis for Children With Cerebral Palsy and Severe Upper Extremity Involvement: A Pilot Study. Ragni, LB., Dlugacz, SK., Sadowsky, C., et al.[2023]

In a study of 95 patients with Juvenile Idiopathic Arthritis (JIA) treated with anti-TNFalpha blockers, various adverse events were reported, including severe headaches and thrombocytopenia associated with Etanercept, and infusion reactions and Anti-dsDNA positivity linked to Infliximab.

Unusual side effects were noted, such as the onset of Crohn's disease in three patients and behavioral modifications, highlighting the need for careful monitoring of children and young adults on anti-TNFalpha therapy to mitigate serious risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Side effects of anti-TNFalpha therapy in juvenile idiopathic arthritis]. Pontikaki, I., Gerloni, V., Gattinara, M., et al.[2019]

A lightweight wrist orthosis designed for children with Cerebral Palsy can assist in improving the coordination of arm movements, which is crucial for performing daily activities.

This device focuses on enhancing wrist movements (pronation/supination and flexion/extension) in a less obtrusive way compared to traditional robotic therapies, potentially leading to better functional outcomes for children with spastic hemiplegic CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A modular low-clearance wrist orthosis for improving wrist motion in children with cerebral palsy. Holley, D., Johnson, M., Harris, G., et al.[2020]

A new dynamic orthosis and static splint device was developed to assist elbow extension in a patient with C5 tetraplegia, allowing for improved functionality of the arm despite paralysis of the triceps muscle.

The device utilizes a rubber ring to provide extension force and features adjustable locking hinges, enabling static splinting to enhance the range of motion in the elbow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new double-purpose device for elbow extension in tetraplegia with paralysis below C5. Itzkovich, M., Catz, A., Ona, I.[2006]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cch.70163?af=R

Effectiveness of Upper Extremity Exoskeletons in Children ... Exoskeleton-based interventions improve upper limb movement accuracy, motor control and functional performance in children with cerebral palsy.

2. withpower.com withpower.com/trial/phase-cerebral-palsy-8-2021-083f3

Orthotic Device for Cerebral Palsy The purpose of this study is to assess the effectiveness of an upper extremity orthotic device in improving the upper extremity function of children with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4882829/

Minimising impairment: Protocol for a multicentre ... Upper limb orthoses are frequently prescribed for children with cerebral palsy (CP) who have muscle overactivity predominantly due to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1877056823003110

The upper limb in children with cerebral palsy. Evaluation ... Management of the upper limb in children with cerebral palsy is often complex and must be carried out by a team experienced in this field.

5. research.aota.org research.aota.org/ajot/article/77/4/7704205060/24923/Design-and-Use-of-a-3D-Printed-Dynamic-Upper

Design and Use of a 3D-Printed Dynamic Upper Extremity ... This pilot study showed that the DUEO, a 3D-printed orthosis, in conjunction with goal-directed therapy, was associated with positive changes in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05024409

Cerebral Palsy Upper Extremity Orthotic Device The purpose of this study is to assess the effectiveness of an upper extremity orthotic device in improving the upper extremity function of children with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11743387/

Robot-assisted upper limb therapy for personalized ... This comprehensive systematic review aimed to investigate the efficacy of robotic systems in improving upper limb (UL) functions in children with CP.