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Cerebral Palsy Upper Extremity Orthotic Device

NCT ID: NCT05024409

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Orthotic + Occupational Therapy

Group Type EXPERIMENTAL

Upper Extremity Orthotic

Intervention Type DEVICE

3D printed orthotic which uses elbow motion to facilitate finger extension

Occupational Therapy alone

Group Type ACTIVE_COMPARATOR

Occupational Therapy

Intervention Type OTHER

6 weekly sessions of occupational therapy, without use of an assistive orthotic device

Interventions

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Upper Extremity Orthotic

3D printed orthotic which uses elbow motion to facilitate finger extension

Intervention Type DEVICE

Occupational Therapy

6 weekly sessions of occupational therapy, without use of an assistive orthotic device

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Alice Chu, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rutgers NJMS

Newark, New Jersey, United States

Site Status RECRUITING

Children's Specialized Hospital

Union, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alice Chu, MD

Role: CONTACT

Phone: 973 972 2076

Email: [email protected]

Facility Contacts

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Alice Chu, MD

Role: primary

Janelle Lenzo-Werner

Role: primary

Other Identifiers

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Pro2020000653

Identifier Type: -

Identifier Source: org_study_id