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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122171
• Other study ID #: 16-02093
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: January 13, 2020

Study information

• Verified date: October 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosis: cerebral palsy

• 4-17 years old

• MACS levels III - V

• Active movement of wrist or elbow

Exclusion Criteria:

• MACS levels I, II

• Botox or orthopedic surgery in past 6 months

• Severe contractures

• Lack of voluntary arm motion

Related Conditions & MeSH terms

• Cerebral Palsy
• Prosthesis User

Intervention

Other:
• Occupational Therapy Treatment
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).

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment	The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. 7 sub-tests will be reported on. Higher scores indicate better HRQOL (Health-Related Quality of Life), an increase in score indicates an increase in HRQOL.	8 weeks