Recruiting

Upper Extremity Orthotic

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05024409

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Upper Extremity Orthotic

Occupational Therapy

Study Details

Brief summary:

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.

Conditions

Cerebral Palsy

Study ID

NCT05024409

Start date

Jan 1, 2023

Status verified date

Dec, 2023

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Orthotic + Occupational Therapy

active comparator: Occupational Therapy alone

Interventions

Upper Extremity Orthotic

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

Occupational Therapy

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

Primary outcome measure

  • 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 [ Time Frame: through study completion, an average of 6 months ]
  • Change in Melbourne Assessment-2 from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment [ Time Frame: through study completion, an average of 6 months ]
  • 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 [ Time Frame: through study completion, an average of 6 months ]
  • Change in range of motion for shoulder, elbow, forearm, wrist, and fingers from 1) pre to post treatment; 2) post treatment to 3 month followup, and 3) pre treatment to 3 mos after cessation of treatment [ Time Frame: pre treatment, immediate post treatment, and 3 month followup ]

Central Contacts and Locations

Central contacts

Alice Chu, MD

973 972 2076chual@njms.rutgers.edu

Locations

Rutgers NJMS

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Alice Chu, MD

973-972-2076chual@njms.rutgers.edu

Children's Specialized Hospital

Recruiting

Union, New Jersey, United States, 07083

Contacts

Janelle Lenzo-Werner

888-244-5373jlenzo-werner@childrens-specialized.org

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Dec 26, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2023-12-26.