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Behavioural Intervention
Specialized Hand Function Therapy for Cerebral Palsy
N/A
Recruiting
Led By Angela Shierk, PhD
Research Sponsored by Texas Scottish Rite Hospital for Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
present with a unilateral upper limb impairment
able to visually attend to objects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess a therapy program that helps young children with cerebral palsy improve hand function and occupational performance. Participants will receive 8 weeks of therapy and researchers will compare to usual care to see if there is a benefit.
Who is the study for?
This trial is for young children aged 3 months to 2 years and 11 months who are at risk for or have been diagnosed with cerebral palsy, show uneven use of their hands, and can focus on objects visually. They should be interested in objects and try to reach or grab them with the less functional arm.
What is being tested?
The study tests 'Therapy Together,' a program designed to improve hand function in kids with unilateral cerebral palsy. Over eight weeks, it's compared against usual care to see if there's better progress in hand skills and daily activities.
What are the potential side effects?
Since this trial involves therapy rather than medication, side effects may include fatigue or frustration during sessions. However, specific side effects will depend on individual responses to the therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have weakness or difficulty moving one of my arms.
Select...
I can see and focus on objects.
Select...
I am at risk for or have been diagnosed with cerebral palsy.
Select...
I can try to grab things with my affected arm.
Select...
My child is between 3 months and 2 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assisting Hand Assessment
Hand Assessment for Infants
Mini-Assisting Hand Assessment
Secondary study objectives
Canadian Occupational Performance Measure
Developmental Assessment for Young Children, Second Edition (DAYC-2)
Measure of Hand and Arm Performance
Other study objectives
Interviews with therapists and caregivers
Pre-training and Post-training Therapist Survey
Weekly Caregiver Log
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Therapy TogetherExperimental Treatment1 Intervention
Participants will complete the 8-week Therapy Together program.
Group II: Usual CareActive Control1 Intervention
Participants will complete 8 weeks of usual care in early intervention.
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Who is running the clinical trial?
Texas Scottish Rite Hospital for ChildrenLead Sponsor
21 Previous Clinical Trials
8,992 Total Patients Enrolled
4 Trials studying Cerebral Palsy
114 Patients Enrolled for Cerebral Palsy
American Occupational Therapy FoundationOTHER
13 Previous Clinical Trials
347 Total Patients Enrolled
Angela Shierk, PhDPrincipal InvestigatorScottish Rite for Children
2 Previous Clinical Trials
70 Total Patients Enrolled
2 Trials studying Cerebral Palsy
70 Patients Enrolled for Cerebral Palsy
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