Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy

NCT03122171 | Completed Results

• 1 other identifier: 16-02093
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in improving the upper extremity function of children with cerebral palsy who have limited use of their hands. Twelve children, aged 4-17 years, who have cerebral palsy and limitations in their ability to use their hands, will be enrolled. All participants will be fitted with a 3D printed arm/hand prosthesis and receive 8 occupational therapy sessions. Each subject will be evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up. The evaluation will include assessment of (1)passive and active arm/hand movement and (2)functional hand skills using several standardized tests. The results from the pre-treatment and the two post-treatment evaluations will be compared.

Conditions

Cerebral Palsy; Prosthesis User

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score

  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. Scores based on 22-items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective). The range of sum scores is 22-88 points. A clinical significant increase in score indicates an increase in quality of performance.

  Week 8

• Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment

  The PMAL is a structured interview in which the caregiver reports "How Often" (amount) and "How Well" (quality of movement) the child uses their involved upper limb when completing 22 activities of daily living. Scores range from 0-10; the higher the score, the better the quality of movement. An increase in PMAL score indicates a higher amount of upper extremity use and better quality of movement.

  8 weeks

• Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores

  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 motion, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement. An increase in score indicates an increase in upper limb movement quality.

  Week 8

Secondary Outcomes (1)

• Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment

  8 weeks

Study Arms (1)

Prosthesis

EXPERIMENTAL

Other: Occupational Therapy Treatment

Interventions

Occupational Therapy Treatment OTHER

Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).

Prosthesis

Eligibility Criteria

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

You may qualify if:

• Diagnosis: cerebral palsy
• years old
• MACS levels III - V
• Active movement of wrist or elbow

You may not qualify if:

• MACS levels I, II
• Botox or orthopedic surgery in past 6 months
• Severe contractures
• Lack of voluntary arm motion

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

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

Results Point of Contact

• Title: Alice Chu, MD
• Organization: Rutgers-New Jersey Medical School

chual@njms.rutgers.edu

(973) 972-2076

Study Officials

• Alice Chu, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: April 1, 2017
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: November 20, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-10

Locations

US (1)