Specialized Hand Function Therapy for Cerebral Palsy

Overseen By Heather Roberts, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Texas Scottish Rite Hospital for Children

Disqualifiers: Uncontrolled epilepsy, Visual impairment, 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: 8

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new therapy program called Therapy Together for young children with unilateral cerebral palsy, focusing on improving hand function and daily activities. Therapy Together is a form of Constraint-Induced Movement Therapy (CIMT), which encourages use of the affected hand by restricting the unaffected hand. The trial aims to determine if this specialized therapy is more effective than usual care and whether it can be smoothly integrated into regular early intervention programs. Children who might be suitable are those at risk for or diagnosed with cerebral palsy, have difficulty using one hand, and show interest in reaching for or grasping objects. Participants will join an 8-week program to compare outcomes with those receiving standard care. As an unphased trial, this study offers a unique opportunity to contribute to innovative therapy development for children with cerebral palsy.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Therapy Together program is safe for young children with cerebral palsy?

Research has shown that pediatric constraint-induced movement therapy (CIMT) is generally well-tolerated by children with one-sided cerebral palsy. A study conducted at multiple centers found that this therapy improved hand function and daily skills in these children. No major side effects emerged, suggesting the therapy's safety. However, some studies mention that the evidence is not very strong, so while the results are promising, they are not yet conclusive. Overall, the therapy appears to be a safe option for helping children with cerebral palsy improve their hand function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Therapy Together program for cerebral palsy because it offers a unique approach to improving hand function through specialized therapy. Unlike standard care, which typically involves generalized early intervention therapies, Therapy Together is specifically designed to engage participants in a targeted 8-week program. This focused approach aims to provide more effective outcomes by concentrating on the specific challenges faced in hand function, offering a promising alternative to traditional methods.

What evidence suggests that the Therapy Together program is effective for improving hand function in children with cerebral palsy?

Research has shown that constraint-induced movement therapy (CIMT) can greatly improve hand use in children with cerebral palsy. One study found CIMT more helpful than regular therapy, while another demonstrated better arm function with CIMT compared to general rehabilitation. Although some research suggests the need for further studies to confirm these findings, current evidence supports CIMT's ability to enhance arm and hand function. In this trial, participants in the "Therapy Together" arm will undergo an 8-week CIMT program, which could effectively help young children with one-sided cerebral palsy improve hand use. Meanwhile, participants in the "Usual Care" arm will receive standard early intervention care. ^{2 3 6 7 8}

Who Is on the Research Team?

Angela Shierk, PhD

Principal Investigator

Scottish Rite for Children

Are You a Good Fit for This Trial?

This trial is for young children aged 3 months to 2 years and 11 months who are at risk for or have been diagnosed with cerebral palsy, show uneven use of their hands, and can focus on objects visually. They should be interested in objects and try to reach or grab them with the less functional arm.

Inclusion Criteria

I can see and focus on objects.

I have weakness or difficulty moving one of my arms.

You have difficulty using one hand more than the other.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete the 8-week Therapy Together program, which includes caregiver education and coaching on implementing therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to improve arm/hand function.

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of hand function and occupational performance.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Therapy Together
• Usual Care

Trial Overview

The study tests 'Therapy Together,' a program designed to improve hand function in kids with unilateral cerebral palsy. Over eight weeks, it's compared against usual care to see if there's better progress in hand skills and daily activities.

How Is the Trial Designed?

Group I: Therapy Together Experimental Treatment 1 Intervention

Participants will complete the 8-week Therapy Together program.

Group II: Usual Care Active Control 1 Intervention

Participants will complete 8 weeks of usual care in early intervention.

Therapy Together is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Therapy Together for:

• Unilateral Cerebral Palsy

Approved in European Union as Constraint-Induced Movement Therapy for:

• Hemiplegic Cerebral Palsy
• Unilateral Cerebral Palsy

Approved in Canada as CIMT for:

• Unilateral Cerebral Palsy
• Hemiparesis associated with Cerebral Palsy

Who Is Running the Clinical Trial?

Texas Scottish Rite Hospital for Children

Lead Sponsor

Trials

23

Recruited

9,000+

American Occupational Therapy Foundation

Collaborator

Trials

14

Recruited

380+

Published Research Related to This Trial

The systematic review found that modified constraint-induced movement therapy (CIMT) showed a significant treatment effect in improving upper limb function in children with hemiplegic cerebral palsy, based on one trial's results.

While there were positive trends favoring CIMT and Forced Use protocols, the overall evidence is limited, suggesting that these therapies should be considered experimental until more rigorous research is conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy. Hoare, BJ., Wasiak, J., Imms, C., et al.[2018]

Constraint-induced movement therapy (CIMT) shows potential benefits for children with hemiplegic cerebral palsy, with one study indicating positive effects on upper limb skills and another showing significant improvements in hand function with modified CIMT.

However, the overall evidence is limited and considered experimental, highlighting the need for more rigorous and adequately powered randomized controlled trials to confirm the effectiveness of CIMT and its variations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy: a Cochrane systematic review. Hoare, B., Imms, C., Carey, L., et al.[2018]

Children with hemiplegic cerebral palsy showed significant improvements in hand strength and dexterity after a 2-week Constraint-Induced Movement Therapy (CIMT) program, which included 4 hours of therapy daily and wearing bi-valve casts.

Electromyography (EMG) analysis indicated increased muscle activation during pinch tasks, suggesting that CIMT not only enhances functional abilities but also positively affects underlying muscle activation patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of constraint-induced movement therapy on hand skills and muscle recruitment of children with spastic hemiplegic cerebral palsy. Stearns, GE., Burtner, P., Keenan, KM., et al.[2009]

In a study involving 42 children with hemiplegic cerebral palsy, both Constraint-Induced Movement Therapy (CIMT) and Hand-Arm Intensive Bimanual Therapy (HABIT) resulted in significant improvements in hand function, as measured by the Jebsen-Taylor Test and Assisting Hand Assessment, with benefits maintained for 6 months.

While both therapies were effective, HABIT showed greater progress towards self-determined goals, suggesting that bimanual training may offer additional advantages in achieving personalized functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Gordon, AM., Hung, YC., Brandao, M., et al.[2022]

Constraint-induced movement therapy (CIMT) has shown significant effectiveness in improving upper extremity use in children with hemiplegic cerebral palsy, particularly in studies with rigorous designs, where large treatment effects were observed.

The review highlighted variability in study designs and outcomes, indicating a need for more standardized research methods to determine the optimal intensity and components of CIMT for different children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bound for success: a systematic review of constraint-induced movement therapy in children with cerebral palsy supports improved arm and hand use. Huang, HH., Fetters, L., Hale, J., et al.[2018]

A multisite randomized controlled trial involving 18 children with unilateral cerebral palsy found that both 3 hours and 6 hours of constraint-induced movement therapy (CIMT) per day for 21 days led to significant improvements in upper extremity function, maintained at 6 months post-treatment.

The study showed no significant difference in the maintenance of gains between the two dosage groups, indicating that both treatment durations were effective in enhancing motor skills without a clear advantage for the longer duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized controlled trial of pediatric constraint-induced movement therapy: 6-month follow-up. Case-Smith, J., DeLuca, SC., Stevenson, R., et al.[2019]

Constraint-Induced Movement Therapy (CIMT) has been shown to effectively improve hand function in children with hemiplegic cerebral palsy, enhancing their independence.

This systematic review included 15 relevant studies, indicating that while CIMT is beneficial compared to no intervention, there are inconsistencies in its effectiveness regarding muscle tone and protective extension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Constraint-Induced Movement Therapy on Functions of Cerebral Palsy Children. Jamali, AR., Amini, M.[2022]

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