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Cerebral Palsy Upper Extremity Orthotic Device

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Enrolling

Conditions

Cerebral Palsy

Treatments

Other: Occupational Therapy
Device: Upper Extremity Orthotic

Study type

Interventional

Funder types

Other

Identifiers

NCT05024409
Pro2020000653

Details and patient eligibility

About

Upper extremity therapies for children with cerebral palsy (CP) have been validated for improving function in higher functioning patients. Those who function at the lowest end of the scale, on the Manual Ability Classification System scale (MACS) III-V, comprise 34-54% of the population, but as yet have no evidence-based interventions specific to their needs. Lower functioning children often retain some voluntary control of the elbow in spite of limited finger motion. A dynamic splint, or exoskeleton, could utilize the tenodesis effect from elbow motion to drive finger release while retaining flexor tone for grasp, potentially creating a portable, home-based therapeutic tool. The purpose of this study is to assess the effectiveness of an upper extremity orthotic device in improving the upper extremity function of children with cerebral palsy who have limited use of their hands.

Enrollment

36 estimated patients

Sex

All

Ages

4 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • mild or extremely severe hand disability, Botox or orthopaedic surgery within the past 6 months, severe contractures, lack of voluntary arm motion, unable to follow commands due to severe cognitive impairment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Orthotic + Occupational Therapy
Experimental group
Treatment:
Device: Upper Extremity Orthotic
Occupational Therapy alone
Active Comparator group
Treatment:
Other: Occupational Therapy

Trial contacts and locations

2

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Central trial contact

Alice Chu, MD

Data sourced from clinicaltrials.gov

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