Therapy Together program for children with unilateral cerebral palsy
Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program
NA · Texas Scottish Rite Hospital for Children · NCT06040619
This study tests if a new therapy program can help young children with unilateral cerebral palsy improve their hand skills and everyday activities better than standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Months to 71 Months |
| Sex | All |
| Sponsor | Texas Scottish Rite Hospital for Children (other) |
| Locations | 1 site (Frisco, Texas) |
| Trial ID | NCT06040619 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Therapy Together program, a pediatric constraint-induced movement therapy designed for young children with unilateral cerebral palsy. Participants aged 3 months to 5 years will engage in an 8-week intervention that includes caregiver education and play-based therapeutic activities aimed at improving hand function and occupational performance. The study compares outcomes between children receiving the Therapy Together program and those receiving usual care, while also assessing the feasibility of implementing this program within standard early intervention frameworks.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 months to 5 years with unilateral cerebral palsy or at risk for developing it, who exhibit asymmetric hand use.
Not a fit: Patients with uncontrolled epilepsy, significant visual impairment, severe behavioral problems, or those unable to complete the assessment protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance hand function and daily performance in young children with unilateral cerebral palsy.
How similar studies have performed: Previous studies on constraint-induced movement therapy have shown promising results, suggesting that this approach may be effective for similar conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * at risk for developing cerebral palsy or have been diagnosed with cerebral palsy * children ages 3 months to 5 years 11 months * present with asymmetric hand use * present with a unilateral upper limb impairment * able to visually attend to objects * demonstrate an interest in objects * attempt to reach for or grasp objects with the impaired upper extremity Exclusion Criteria: * uncontrolled epilepsy * significant visual impairment * severe behavioral problems * inability to complete the assessment protocol.
Where this trial is running
Frisco, Texas
- Scottish Rite for Children — Frisco, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Angela Shierk, PhD — Scottish Rite for Children
- Study coordinator: Angela Shierk, PhD
- Email: angela.shierk@tsrh.org
- Phone: (469) 412-7172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, Hemiplegic Cerebral Palsy, constraint induced movement therapy, caregiver coaching