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Completed

NCT Number: NCT03122171

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Prosthesis User

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2017
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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