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?

Upper extremity therapies for children with cerebral palsy (CP) have been validated for improving function in higher functioning patients. Those who function at the lowest end of the scale, on the Manual Ability Classification System scale (MACS) III-V, comprise 34-54% of the population, but as yet have no evidence-based interventions specific to their needs. Lower functioning children often retain some voluntary control of the elbow in spite of limited finger motion. A dynamic splint, or exoskeleton, could utilize the tenodesis effect from elbow motion to drive finger release while retaining flexor tone for grasp, potentially creating a portable, home-based therapeutic tool. 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 cerebral palsy who have limited use of their hands.

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 safety data exists for orthotic devices used in cerebral palsy treatment?

The provided research does not contain specific safety data for orthotic devices used in cerebral palsy treatment. The studies focus on biologic therapies for juvenile idiopathic arthritis, discussing their efficacy and safety, particularly concerning adverse events like infections and malignancies. No information is available on orthotic devices or related treatments such as occupational therapy or dynamic splints. ^{1 2 3 4 5}

Is the Upper Extremity Orthotic a promising treatment for Cerebral Palsy?

Yes, the Upper Extremity Orthotic is a promising treatment for Cerebral Palsy. It helps improve arm and hand function, allowing children to perform daily activities better. The orthotic can be customized to fit individual needs, promoting better movement and reducing muscle tightness. It also supports wrist and elbow motion, which can lead to improved motor skills and greater independence. ^{6 7 8 9 10}

What data supports the idea that Orthotic Device for Cerebral Palsy is an effective treatment?

The available research shows that using dynamic splints, a type of orthotic device, can improve grip strength and dexterity in children with cerebral palsy. In a study, children with spastic hemiplegia, a form of cerebral palsy, showed better hand function when wearing dynamic splints compared to not wearing any splints. Specifically, their grip strength and dexterity improved significantly. This suggests that dynamic splints can help children with cerebral palsy use their hands more effectively. ^{8 11 12 13 14}

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

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Tolerance and effectiveness of a new dynamic hand-wrist orthosis in chronic stroke patients. [2016]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Rationale for prescription, and effectiveness of, upper limb orthotic intervention for children with cerebral palsy: a systematic review. [2019]

6. Italy pubmed.ncbi.nlm.nih.gov

[Side effects of anti-TNFalpha therapy in juvenile idiopathic arthritis]. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Biologics for the treatment of juvenile idiopathic arthritis: a systematic review and critical analysis of the evidence. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Long-term surveillance of biologic therapies in systemic-onset juvenile idiopathic arthritis: data from the German BIKER registry. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Management of Children with Juvenile Idiopathic Arthritis. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

The safety profile of biologic therapies for juvenile idiopathic arthritis. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

Customized adjustable orthoses: their use in spasticity. [2005]

13. England pubmed.ncbi.nlm.nih.gov

A new double-purpose device for elbow extension in tetraplegia with paralysis below C5. [2006]

14. United States pubmed.ncbi.nlm.nih.gov

A modular low-clearance wrist orthosis for improving wrist motion in children with cerebral palsy. [2020]