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

Not Applicable

Completed

• Conditions: Cerebral Palsy; Prosthesis User
• Interventions: Other: Occupational Therapy Treatment

• Registration Number: NCT03122171
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-13
• Status Verified: 2020-10
• Results First Submitted: 2020-10-29
• Results First Submitted QC: 2020-10-29
• Last Update Submitted: 2020-10-29
• Results First Posted: 2020-11-20
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Diagnosis: cerebral palsy
• 4-17 years old
• MACS levels III - V
• Active movement of wrist or elbow

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prosthesis	Occupational Therapy Treatment	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores	Week 8	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.
Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment	8 weeks	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.
Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score	Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment	8 weeks	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States