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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 hour group | Active Comparator | The 4-hour group completed 32 hours in clinic and 24 hours at home (30 minutes per day) to complete the Therapy Together program. |
|
| 1 hour group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy Together - 4 hour group | Behavioral | a caregiver partnered constraint induced movement therapy program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Assisting Hand Assessment | 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) | pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention] |
| Assisting Hand Assessment | 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) | pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Occupational Performance Measure | 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) | pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Shierk | Scottish Rite for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottish Rite for Children | Frisco | Texas | 75034 | United States |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Therapy Together - 1 hour group | Behavioral | a caregiver partnered constraint induced movement therapy program |
|
| Developmental Assessment for Young Children, Second Edition (DAYC-2) |
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) |
| pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention |
| Weekly Caregiver Log | The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4 | weekly for 8 weeks |