Implementation of Therapy Together

Texas Scottish Rite Hospital for Children

Status: Enrolling

Conditions: Cerebral Palsy; Hemiplegic Cerebral Palsy

Treatments: Behavioral: Usual Care; Behavioral: Therapy Together

Study type: Interventional

Funder types: Other

Identifiers

NCT06040619

STU-2023-0553

Details and patient eligibility

About

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.

Full description

A randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 yrs 11 mo) with unilateral cerebral palsy (or at risk for developing cerebral palsy) and caregivers comparing Therapy Together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of Therapy Together within early intervention.

Therapy Together Program:

The Therapy Together program 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. The child and caregiver complete 8 sessions with their therapist. The therapist is trained to educate the caregiver on the Therapy Together program, demonstrate how to engage the child in therapeutic activities, and observe the caregiver implement the program during each weekly session. The first 7 intervention visits focus on constraint-induced movement therapy (CIMT) and the final intervention visit focuses on bimanual therapy (use of two hands).

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 71 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Therapy Together

Experimental group

Description:

Participants will complete the 8-week Therapy Together program.

Treatment:

Behavioral: Therapy Together

Usual Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Care