Feasibility and Effectiveness of Therapy Together
- Conditions
- Cerebral Palsy
- Registration Number
- NCT07225673
- Lead Sponsor
- Texas Scottish Rite Hospital for Children
- Brief Summary
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.
- Detailed 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 37
- 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
- uncontrolled epilepsy
- significant visual impairment
- severe behavioral problems
- inability to complete the assessment protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mini-Assisting Hand Assessment pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention] The Mini-Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assesses bimanual hand function for children with cerebral palsy aged 8-18 months (measured in logits/units)
Assisting Hand Assessment pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units)
- Secondary Outcome Measures
Name Time Method Canadian Occupational Performance Measure pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention The Canadian Occupational Performance Measure is an interview-based assessment of self-perception of performance of everyday living activities (measured on a scale from 1-10)
Developmental Assessment for Young Children, Second Edition (DAYC-2) pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention The Developmental Assessment for Young Children is an interview and observation based norm-referenced developmental assessment (raw scores 0 or 1, converted to standard scores)
Weekly Caregiver Log weekly for 8 weeks The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4
Trial Locations
- Locations (1)
Scottish Rite for Children
🇺🇸Frisco, Texas, United States
Scottish Rite for Children🇺🇸Frisco, Texas, United States