Cerebral Palsy Upper Extremity Orthotic Device

NCT05024409 | Unknown

• 1 other identifier: Pro2020000653
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• 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

  The Assisting Hand Assessment (AHA) is a test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance. An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session. The scale is 0-100, and a higher score indicates better function. A change of +5 is clinically significant.

  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

  The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of movement, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement. The full test comprises 14 test items which require a child to reach to, grasp, release and manipulate simple objects. Each child's test performance is video recorded for subsequent scoring. Scoring is completed across the 30 score items using a three, four or five point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale. A raw score scale change of 3 for range of motion, dexterity, and fluency; and a change of 4 for accuracy is considered clinically significant.

  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

  CHEQ is a newly developed questionnaire. It has been developed for children and adolescents with decreased function in one hand, for example hemiplegic CP, obstetric brachial plexus palsy (OBPP) and upper limb reduction deficiency, and for their parents. The scale is 0-100, with the higher score indicating better abilities.

  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

  pre treatment, immediate post treatment, and 3 month followup

Secondary Outcomes (1)

• 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

  pre treatment, immediate post treatment

Study Arms (2)

Orthotic + Occupational Therapy

EXPERIMENTAL

Device: Upper Extremity Orthotic

Occupational Therapy alone

ACTIVE COMPARATOR

Other: Occupational Therapy

Interventions

Upper Extremity Orthotic DEVICE

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

Orthotic + Occupational Therapy

Occupational Therapy OTHER

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

Occupational Therapy alone

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Rutgers NJMS

Newark, New Jersey, 07103, United States

RECRUITING

Children's Specialized Hospital

Union, New Jersey, 07083, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Alice Chu, MD

CONTACT

973 972 2076; chual@njms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 27, 2021
• Study Start: January 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)