30 Participants Needed

Specialized Hand Function Therapy for Cerebral Palsy

AS
HR
Overseen ByHeather Roberts, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Texas Scottish Rite Hospital for Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 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.12345

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.12456

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.13467

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.

Research Team

AS

Angela Shierk, PhD

Principal Investigator

Scottish Rite for Children

Eligibility Criteria

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.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Therapy TogetherExperimental Treatment1 Intervention
Participants will complete the 8-week Therapy Together program.
Group II: Usual CareActive Control1 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

Find a Clinic Near You

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+

Findings from Research

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

References

Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. [2022]
Effects of constraint-induced movement therapy on hand skills and muscle recruitment of children with spastic hemiplegic cerebral palsy. [2009]
The Effects of Constraint-Induced Movement Therapy on Functions of Cerebral Palsy Children. [2022]
Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy: a Cochrane systematic review. [2018]
Multicenter randomized controlled trial of pediatric constraint-induced movement therapy: 6-month follow-up. [2019]
Bound for success: a systematic review of constraint-induced movement therapy in children with cerebral palsy supports improved arm and hand use. [2018]
Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy. [2018]
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