Feasibility and Effectiveness of Therapy Together

Texas Scottish Rite Hospital for Children

Status: Active, not recruiting

Conditions: Cerebral Palsy

Treatments: Behavioral: Therapy Together - 4 hour group; Behavioral: Therapy Together - 1 hour group

Study type: Interventional

Funder types: Other

Identifiers

NCT07225673

STU-2019-1211

Details and patient eligibility

About

this study proposes to compare the feasibility and effectiveness of 2 methods of delivery of Therapy Together, a caregiver and child intensive upper limb therapy program for children with CP and children at risk for developing CP ages 3 months - 4 years 11 months.

Full description

One group will complete 32 hours onsite (4 hour weekly sessions) and 30 minutes of therapeutic activity at home, and the second group will complete 8 hours onsite and 1 hour of therapeutic activity at home. Both groups will aim to complete 56 hours of the intervention.

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 coaching sessions. 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: 37 estimated patients

Sex: All

Ages: 3 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• present with asymmetric hand
• at risk for developing CP or children that have been diagnosed with CP
• must be able to visually attend to objects
• demonstrate an interest in objects
• attempt to reach for or grasp them 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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

37 participants in 2 patient groups

4 hour group

Active Comparator group

Description:

The 4-hour group completed 32 hours in clinic and 24 hours at home (30 minutes per day) to complete the Therapy Together program.

Treatment:

Behavioral: Therapy Together - 4 hour group

1 hour group

Active Comparator group

Description:

The 1-hour group completed 8 hours of in-clinic therapy and 48 hours of home-based activities (1 hour per day) to complete the Therapy Together program.

Treatment:

Behavioral: Therapy Together - 1 hour group