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Orthotic Device

Orthotic + Occupational Therapy 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months

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

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

Primary outcome measures

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

+1 more

Secondary outcome measures

Change in motion analysis parameters from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Orthotic + Occupational TherapyExperimental Treatment1 Intervention

Group II: Occupational Therapy aloneActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,196 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available openings for patients to participate in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is actively seeking eligible participants. The trial was initially posted on January 1st, 2023 and recently updated on December 21st, 2023. With two sites involved in the trial, a total of 36 patients are being sought for enrollment."

Answered by AI

Which individuals are eligible to participate in this clinical investigation?

"To be eligible for enrollment in this study, candidates must meet specific criteria. These include having a confirmed diagnosis of cerebral palsy and being between the ages of 4 and 17 years old. Additionally, participants should have moderate to severe hand disability as determined by the Manual Ability Classification System. Other requirements include active movement of the elbow, ability to follow instructions, and willingness to engage in goal-oriented activities and repetitive tasks."

Answered by AI

Is the study actively seeking participants who are above the age of 50?

"To be eligible for enrollment in this study, participants must have an age between 4 and 17 years old."

Answered by AI

How large is the participant pool in this medical study?

"Indeed, the information provided on clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking eligible participants. The initial posting date for this study was January 1, 2023, and the most recent update occurred on December 21, 2023. The trial aims to enroll a total of 36 patients across two designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cerebral Palsy Upper Extremity Orthotic Device

Alice Chu, MD 2023. "Cerebral Palsy Upper Extremity Orthotic Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05024409.

All > Cerebral Palsy