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Orthotic Device

Orthotic Device for Cerebral Palsy

N/A
Recruiting
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* diagnosis of cerebral palsy, age 4-17 years, moderate-severe hand disability as graded by the Manual Ability Classification System, active movement of the elbow, ability to follow commands and participate in goal-making and repetitive tasks
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights

Summary

This trial aims to test the effectiveness of a special device that can help children with cerebral palsy who have limited use of their hands. The device is like a brace that can be worn on the arm

Who is the study for?
This trial is for children aged 4-17 with cerebral palsy who have moderate to severe hand disabilities. They must be able to move their elbow, follow commands, and participate in setting goals and doing repetitive tasks.
What is being tested?
The study tests an upper extremity orthotic device (a type of dynamic splint or exoskeleton) combined with occupational therapy to improve arm function in children with limited hand use due to cerebral palsy.
What are the potential side effects?
While the document does not specify side effects, typical concerns may include discomfort from wearing the device, skin irritation, or muscle fatigue during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Assisting Hand Assessment from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
Change in Children's Hand Use Experience Questionnaire from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment
Therapeutic procedure

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Orthotic + Occupational TherapyExperimental Treatment1 Intervention
Group II: Occupational Therapy aloneActive Control1 Intervention

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Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,346 Total Patients Enrolled
~12 spots leftby Sep 2025
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