Cerebral Palsy
Conditions
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).
Interventions
BEHAVIORALTherapy Together - 4 hour group
a caregiver partnered constraint induced movement therapy program
BEHAVIORALTherapy Together - 1 hour group
a caregiver partnered constraint induced movement therapy program
Sponsors
Texas Scottish Rite Hospital for Children
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed