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?

The goal of this clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. The main question\[s\] it aims to answer are: * Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care? * Is it feasible to implement the Therapy Together program within the standard care, early intervention framework? Participants will participate in an 8-week pediatric constraint-induced movement therapy program. Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.

Will I have to stop taking my current medications?

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

Is Constraint-Induced Movement Therapy (CIMT) safe for children with cerebral palsy?

The research on Constraint-Induced Movement Therapy (CIMT) for children with cerebral palsy does not report any safety concerns, suggesting it is generally safe for use in this population. ^{1 2 3 4 5}

How is the treatment Therapy Together (CIMT) different from other treatments for cerebral palsy?

Therapy Together, or Constraint-Induced Movement Therapy (CIMT), is unique because it involves restraining the less-affected hand to encourage the use of the affected hand, promoting better hand function through intensive practice. This approach is different from other treatments as it specifically targets increasing the spontaneous use of the affected limb, helping to overcome developmental disregard where the affected limb is often ignored. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment Therapy Together, Constraint-Induced Movement Therapy (CIMT), Pediatric Constraint-Induced Movement Therapy, Usual Care, Standard Care, Conventional Care for cerebral palsy?

Research shows that Constraint-Induced Movement Therapy (CIMT) can improve hand function in children with cerebral palsy by encouraging the use of the affected hand through intensive practice and restraining the less-affected hand. Studies indicate that CIMT leads to better hand skills and muscle activation, which are important for functional gains in children with hemiplegic cerebral palsy. ^{1 3 4 5 6}

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

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]

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]

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]

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]

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 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]

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]

Citations

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

Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of constraint-induced movement therapy on hand skills and muscle recruitment of children with spastic hemiplegic cerebral palsy. [2009]

3. Iran pubmed.ncbi.nlm.nih.gov

The Effects of Constraint-Induced Movement Therapy on Functions of Cerebral Palsy Children. [2022]

4. England 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. [2018]

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

Multicenter randomized controlled trial of pediatric constraint-induced movement therapy: 6-month follow-up. [2019]

6. United States 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy. [2018]