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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

Study 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.Check my eligibility

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.See study design

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 below

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I have weakness or difficulty moving one of my arms.

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I can see and focus on objects.

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I am at risk for or have been diagnosed with cerebral palsy.

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I can try to grab things with my affected arm.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assisting Hand Assessment

Hand Assessment for Infants

Mini-Assisting Hand Assessment

Secondary outcome measures

Canadian Occupational Performance Measure

Developmental Assessment for Young Children, Second Edition (DAYC-2)

Measure of Hand and Arm Performance

Other outcome measures

Interviews with therapists and caregivers

Pre-training and Post-training Therapist Survey

Weekly Caregiver Log

+1 more

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Texas Scottish Rite Hospital for ChildrenLead Sponsor

18 Previous Clinical Trials

8,808 Total Patients Enrolled

3 Trials studying Cerebral Palsy

90 Patients Enrolled for Cerebral Palsy

American Occupational Therapy FoundationOTHER

12 Previous Clinical Trials

333 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research trial accepting senior citizens as participants?

"For this trial, participants must be between 3 and 35 months old."

Answered by AI

Does the current protocol allow for enrollment?

"This clinical research is actively seeking participants, as indicated on the trial's page hosted on clinicialtrials.gov. The information was first made available to the public on November 1st of 2023 and has since been revised once more in 13th of that same month."

Answered by AI

What criteria are necessary to be considered a viable candidate for this trial?

"This medical trial requires 30 infants between the ages of 3 months and 35 months who are either at risk for cerebral palsy or have already been diagnosed with it. Furthermore, those accepted must demonstrate an interest in objects, a unilateral upper limb impairment, and be able to attend visually to them. Additionally they need to display attempts to reach out for or grasp items using their impaired upper extremity."

Answered by AI

How many people have been enlisted for this clinical trial?

"Affirmative. Clinicaltrials.gov currently corroborates that this clinical trial is actively accepting patients; the original posting was on November 1st 2023 and it has been amended as recently as November 13th, 2023. The plan calls for enrolling 30 participants from one site location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Implementation of Therapy Together

Angela Shierk 2023. "Implementation of Therapy Together". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06040619.

All > Cerebral Palsy